News Archives - Diadem DX

Diadem Unveils Novel Findings on Early Alzheimer’s Disease Detection Using p53-Specific Antibody at CTAD 2024

minnac — Fri, 01 Nov 2024 07:30:13 +0000

Diadem Unveils Novel Findings on Early Alzheimer’s Disease Detection Using p53-Specific Antibody at CTAD 2024

Milano, Italy, November 1, 2024<\/strong> \u2013 Diadem SpA, in partnership with researchers from the University of Texas Medical Branch, led by Prof. Rakez Kayed from the Mitchell Center for Neurodegenerative Disorders, presented groundbreaking findings at the 2024 Clinical Trials on Alzheimer\u2019s Disease (CTAD) conference. The study focused on U-p53AZ, a conformational variant of the p53 protein linked to Alzheimer\u2019s disease (AD). Using a U-p53AZ-specific antibody developed by Diadem, the team identified the presence of this misfolded protein in human brain tissue, providing critical insights into AD pathology.<\/p>\n
<\/p>\n
Managing cognitive decline and dementia is particularly challenging in the early stages, partly due to the lack of reliable and affordable biomarkers. Misfolding of the p53 protein, detected by U-p53AZ, has been developed as a prognostic tool for AD. Previous studies showed that measuring U-p53AZ levels in plasma using a proprietary antibody could predict the risk of significant cognitive deterioration in Alzheimer’s disease (AD). This current study extends those findings by applying the U-p53AZ antibody to brain tissue, further validating its role in AD diagnosis.<\/p>\n
<\/p>\n
Researchers applied U-p53AZ to brain samples from various Braak stages, which track AD progression. The antibody selectively bound to misfolded p53 in AD tissues, with minimal binding in healthy controls. Co-staining with phosphorylated tau (pTau), a key AD marker, reinforced the association between p53 misfolding and tau pathology, suggesting a strong link to AD progression.<\/p>\n
<\/p>\n
Prof. Rakez Kayed stated, \u201cThe co-localization of misfolded p53 with phosphorylated tau suggests a mechanistic interaction that warrants further investigation, particularly as a target for early diagnostic intervention.\u201d His comments underscore the significance of the findings in identifying new diagnostic and therapeutic strategies.<\/p>\n
<\/p>\n
Dr. Sam Agus, Chief Medical Officer at Diadem, added, \u201cOur results demonstrate that U-p53AZ not only identifies a conformation-specific form of p53 linked to Alzheimer\u2019s disease but also correlates with disease severity through Braak staging.<\/p>\n
<\/p>\n
The study expands on prior work (Piccirella et al, JPAD, 2022), positioning U-p53AZ as a robust tool for both early and advanced AD detection. Its potential for clinical application in diagnostic settings is significant, particularly in light of its ability to distinguish AD-related p53 misfolding from normal p53 conformations.<\/p>\n
<\/strong><\/p>\n
For more information, contact:<\/strong>
Diadem:
Michael Rasche
CEO
execadmin@diademdx.co.uk<\/p>\n
About Diadem SpA<\/strong>
Diadem SpA is a leader in diagnostic solutions for Alzheimer\u2019s and neurodegenerative diseases. Based in Milano, Italy, Diadem focuses on early detection to improve patient outcomes.<\/p>","tablet":"
Milan, Italy and Secaucus, NJ<\/strong> -- October 25, 2023 \u2013 Diadem SpA, (Diadem), a company developing one of the first blood-based tests for the early and accurate prediction of clinical progression to Alzheimer\u2019s disease (AD), today announced that it has formed a strategic collaboration with Quest Diagnostics (NYSE: DGX), the nation\u2019s leading provider of diagnostic information services, designed to improve access to high quality blood tests for evaluating the risk of Alzheimer\u2019s disease.<\/p>\n
Under terms of the agreement, Diadem has licensed exclusive U.S. rights to the intellectual property of its AlzoSure\u00ae Predict blood-based prognostic technology to Quest for the purpose of developing, validating and marketing a laboratory-developed test service for providers and patients in the U.S. Financial details of the agreement were not disclosed.<\/p>\n
The U.S. Food and Drug Administration granted the AlzoSure\u00ae test Breakthrough Device Designation in January 2022. The test helps identify a variant of the p53 protein that is implicated in AD.<\/p>\n
\"Reliable, convenient and affordable blood tests are essential to the identification of AD risk in early stages, when interventions hold the greatest potential to slow disease progression,\" said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. \"We are encouraged by the clinical research and FDA breakthrough designation for AlzoSure\u00ae and the opportunity to broaden quality and access to AD testing options supporting better patient care.\"<\/p>\n
\u201cWe are delighted to be working with Quest, an industry leader and innovator in novel prognostic and diagnostic tests for Alzheimer's disease, to advance the development and commercialization of test options in the U.S. based on our AlzoSure Predict\u00ae technology,\u201d said Paul Kinnon, Chief Executive Officer of Diadem. \u201cThe decade of work by our researchers and collaborators to clinically validate this important technology is bearing fruit as new therapies and growing knowledge about Alzheimer\u2019s disease are providing hope that early interventions may slow or stop disease progression. We see AlzoSure\u00ae Predict as a potentially valuable contributor in this effort and view Quest as the ideal collaborator to help make the benefits of the AlzoSure\u00ae technology widely available to patients and their healthcare providers as part of Quest\u2019s quality test portfolio.\u201d<\/p>\n
A large body of clinical data supports the utility of Diadem\u2019s AlzoSure\u00ae Predict blood-based technology, suggesting it can help identify whether or not individuals over the age of 50 will experience significant cognitive decline due to Alzheimer\u2019s disease up to six years before the onset of symptoms (area under the curve greater than 98%). Data presented at the Alzheimer\u2019s Association International Conference in July 2023 confirmed the strong prognostic performance of AlzoSure\u00ae Predict based on longitudinal data from 479 individuals aged 60-85 who participated in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study.<\/p>\n
This comprehensive dataset enabled evaluation of the performance of AlzoSure\u00ae Predict in assessing the risk that study participants would experience a significant cognitive decline to Alzheimer\u2019s disease over time, and in identifying the timeframe during which this decline would occur (2 years for \u201crapid progressors\u201d and 6 years for \u201cslow progressors\u201d).<\/p>\n
More than 6 million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Conventional tests for Alzheimer\u2019s involve specialist-delivered PET scans and cerebral spinal fluid testing in symptomatic individuals. New blood tests offer the potential for primary care physicians as well as specialists to identify people at risk for Alzheimer's disease even before symptoms manifest.<\/p>\n
Quest Diagnostics has a long-standing history of advancing diagnostic innovation in the field of dementia, including Alzheimer's disease. The company\u2019s AD-Detect\u2122 portfolio features blood tests to evaluate risk associated with amyloid beta (AB) 42\/40 proteins as well as ApoE genetic risk. The company\u2019s AD-test services also include panels by cerebrospinal fluid (CSF) that help providers assess amyloid beta 42, tau and ApoE status. The company continues to explore the potential of other biomarkers for assessing AD risk that may complement its existing portfolio. For more information, visit Questforthecure.com.<\/p>\n
About AlzoSure\u00ae Predict<\/strong><\/p>\n
AlzoSure\u00ae Predict is a non-invasive biomarker blood-based technology that uses a proprietary antibody (U-p53AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. The utility of AlzoSure\u00ae Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure\u00ae Predict\u2019s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the E.U. AlzoSure\u00ae Predict requires only 1mL of blood to detect the risk of Alzheimer\u2019s disease at the asymptomatic and early symptomatic stage. The AlzoSure\u00ae Predict technology can also identify individuals at high risk of progressing to Alzheimer\u2019s disease within 2 years. Research has also demonstrated that AlzoSure\u00ae Predict can discriminate between the different kinds of dementia with high accuracy.<\/p>\n
About Diadem<\/strong><\/p>\n
Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer\u2019s disease. The lack of accurate, accessible and affordable diagnostic tools has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem\u2019s rapid, accurate and cost-effective AlzoSure\u00ae Predict blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are now potentially achievable. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support adoption and use. Diadem is preparing for commercialisation of AlzoSure\u00ae Predict in collaboration with global strategic partners. The company is also developing AlzoSure\u00ae Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.mywebpreview.co.uk\/.<\/p>","phone":"
Milan, Italy and San Francisco, California, December 5, 2022<\/strong> \u2013 Diadem SpA, a company developing the first blood-based test for the early prediction of progression to Alzheimer\u2019s disease (AD), presented clinical data at the 15^{th<\/sup> Clinical Trials on Alzheimer\u2019s Disease (CTAD) conference highlighting the accuracy and clinical utility of its AlzoSure^{\u00ae<\/sup> Predict prognostic blood test for Alzheimer\u2019s Disease (AD), setting the stage for commercialization in the U.S. beginning in 2023.<\/p>\n\n}}
In the presentation by Diadem Chief Medical Officer Dr. Sam Agus on December 2^{nd<\/sup>, Diadem discussed how AlzoSure^{\u00ae<\/sup> Predict can aid pharmaceutical and biotechnology companies for screening, enrichment and stratification of patient populations to facilitate Alzheimer\u2019s disease clinical trials. Use of the test enables drug developers to identify individuals who will experience a decline to Alzheimer\u2019s dementia up to six years in advance of diagnosis with high confidence, regardless of their cognitive, amyloid, or tau measurement status at the time of testing. This type of patient stratification can improve clinical trial recruitment and the odds of success, as it ensures that patients participating in the trials have a very high probability of developing full-blown AD.<\/p>\n\n}}
Additionally, Dr. Agus discussed the utility of the test as a screening tool to enable physicians and patients to identify those at high risk of developing AD very early in the disease process, when therapies may be most effective. The likely approval of new drugs such as lecanemab from Eisai and Biogen, which shows promising signs of slowing cognitive decline in early AD, highlights the need for accurate and economical screening tools to select patients most likely to benefit from early treatment.<\/p>\n\n
\u201cThis is an exciting time in the battle against Alzheimer\u2019s disease,\u201d said Paul Kinnon, CEO of Diadem. \u201cAdvances in AD diagnosis and therapies are finally providing hope that we can begin to slow or stop the progression of this terrible disease that impacts so many individuals and families. We see AlzoSure^{\u00ae<\/sup> Predict playing a key role in this progress, with its wide potential accessibility and its ability to enhance AD clinical trials and to identify individuals at high risk for progression to AD. As we expected, global market research we are in the process of conducting is showing that both individuals and physicians indicate strong interest in early access to better diagnostic tools for Alzheimer\u2019s.\u201d<\/p>\n\n}
Mr. Kinnon continued, \u201cOur studies show that AlzoSure^{\u00ae<\/sup> Predict is able to predict cognitive decline to AD dementia with an AUC greater than 90%, regardless of the cognitive, amyloid, or tau status of the patient at the time of the test. AlzoSure also showed superiority compared to Pib-PET amyloid imaging in predicting decline to AD dementia in patients before, or with, early signs of cognitive deficits. We now are in the final stages of further validating these findings using longitudinal data from the U.S.-based Alzheimer's Disease Research Centers (ADRC) and Alzheimer\u2019s Disease Neuroimaging Initiative (ADNI) cohorts, and look forward to releasing results in the coming months. We also are preparing for the commercial launch of AlzoSure^{\u00ae<\/sup> Predict in the U.S. in the new year, in collaboration with a major diagnostics partner.\u201d<\/p>\n\n}}
AlzoSure^{\u00ae<\/sup> Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer\u2019s disease up to six years before diagnosis. AlzoSure^{\u00ae<\/sup> Predict uses a proprietary antibody (U-p53^{AZ<\/sup>) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. Previous studies<\/a><\/span> suggest that this p53 variant has utility as a diagnostic and as a predictive biomarker to identify individuals likely to progress to AD up to six years before symptoms appear.<\/p>\n}}}
The utility of AlzoSure^{\u00ae<\/sup> Predict is supported by}clinical data<\/a><\/span> from a large longitudinal study that was the basis for AlzoSure^{\u00ae<\/sup> Predict\u2019s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the EU. AlzoSure^{\u00ae<\/sup> Predict requires only 1mL of blood and 4 to 5 days for analysis to detect AD at the asymptomatic and prodromal (early symptomatic) stage, with an accuracy greater than 95% up to at least 6 years in advance of the clinical onset of symptoms. Previous research also demonstrated that AlzoSure^{\u00ae<\/sup> Predict can discriminate between the different kinds of dementia with high accuracy.<\/p>\n}}}
About Diadem<\/strong><\/p>\n
Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer\u2019s disease. The lack of accurate, accessible and affordable diagnostic tools is a major contributor to the absence of effective treatments for this devastating condition. As a result, patients are not diagnosed until late in the illness, when effective treatment is no longer possible. Diadem\u2019s rapid, accurate and cost-effective blood-based prognostic test makes it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are far more feasible. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support widespread adoption and use. Diadem is preparing for commercialisation of AlzoSure^{\u00ae<\/sup><\/strong> Predict in collaboration with global strategic partners. The company is also developing AlzoSure^{\u00ae<\/sup> Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit}}diademdx.mywebpreview.co.uk\/.<\/a><\/p>"}},"slug":"et_pb_text"}" data-et-multi-view-load-tablet-hidden="true" data-et-multi-view-load-phone-hidden="true">
Milano, Italy, November 1, 2024 – Diadem SpA, in partnership with researchers from the University of Texas Medical Branch, led by Prof. Rakez Kayed from the Mitchell Center for Neurodegenerative Disorders, presented groundbreaking findings at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference. The study focused on U-p53AZ, a conformational variant of the p53 protein linked to Alzheimer’s disease (AD). Using a U-p53AZ-specific antibody developed by Diadem, the team identified the presence of this misfolded protein in human brain tissue, providing critical insights into AD pathology.

Managing cognitive decline and dementia is particularly challenging in the early stages, partly due to the lack of reliable and affordable biomarkers. Misfolding of the p53 protein, detected by U-p53AZ, has been developed as a prognostic tool for AD. Previous studies showed that measuring U-p53AZ levels in plasma using a proprietary antibody could predict the risk of significant cognitive deterioration in Alzheimer’s disease (AD). This current study extends those findings by applying the U-p53AZ antibody to brain tissue, further validating its role in AD diagnosis.

Researchers applied U-p53AZ to brain samples from various Braak stages, which track AD progression. The antibody selectively bound to misfolded p53 in AD tissues, with minimal binding in healthy controls. Co-staining with phosphorylated tau (pTau), a key AD marker, reinforced the association between p53 misfolding and tau pathology, suggesting a strong link to AD progression.

Prof. Rakez Kayed stated, “The co-localization of misfolded p53 with phosphorylated tau suggests a mechanistic interaction that warrants further investigation, particularly as a target for early diagnostic intervention.” His comments underscore the significance of the findings in identifying new diagnostic and therapeutic strategies.

Dr. Sam Agus, Chief Medical Officer at Diadem, added, “Our results demonstrate that U-p53AZ not only identifies a conformation-specific form of p53 linked to Alzheimer’s disease but also correlates with disease severity through Braak staging.

The study expands on prior work (Piccirella et al, JPAD, 2022), positioning U-p53AZ as a robust tool for both early and advanced AD detection. Its potential for clinical application in diagnostic settings is significant, particularly in light of its ability to distinguish AD-related p53 misfolding from normal p53 conformations.

For more information, contact:
Diadem:
Michael Rasche
CEO
execadmin@diademdx.co.uk

About Diadem SpA
Diadem SpA is a leader in diagnostic solutions for Alzheimer’s and neurodegenerative diseases. Based in Milano, Italy, Diadem focuses on early detection to improve patient outcomes.

The post Diadem Unveils Novel Findings on Early Alzheimer’s Disease Detection Using p53-Specific Antibody at CTAD 2024 appeared first on Diadem DX.

Diadem Appoints Michael Rasche as Chief Executive Officer

clairenicholson078 — Wed, 10 Jul 2024 11:00:08 +0000

Diadem Appoints Michael Rasche as Chief Executive Officer

Brings International Perspective and Extensive Experience Across Multiple Life Sciences Sectors to Advance Diadem’s Pioneering Prognostic Technology for the Early Detection of Alzheimer’s Disease

<\/strong><\/p>\n
<\/strong><\/p>\n
Milan, Italy \u2013 July 10, 2024<\/strong> \u2013 Diadem SpA, (Diadem), a company developing one of the first blood-based tests for the early and accurate prediction of clinical progression to Alzheimer\u2019s disease (AD), today announced that Michael Rasche has been named Chief Executive Officer (CEO) and a member of the Board of Directors. Mr. Rasche brings Diadem more than three decades of experience in driving life sciences\u00a0 innovations to commercial success across Europe and the Americas. The company also announced that\u00a0 former CEO Paul Kinnon will continue to serve on the Diadem SpA board and has been named Chairman of Diadem US, Inc.<\/p>\n
<\/p>\n
Dr. Gerald M\u00f6ller, Chair of Diadem\u2019s Board of Directors, commented, \u201cI am delighted that Michael will be leading Diadem at this exciting time for the company. Michael\u2019s broad experience spans leadership roles in market development, sales and general management in our industry. His drive, skills and commitment have enabled him to successfully commercialize multiple innovative products. The growing number of therapeutic options for AD highlight the importance of identifying and monitoring Alzheimer\u2019s patients early, with growing evidence that early interventions can slow disease progression. Our AlzoSure^{\u00ae<\/sup><\/strong> prognostic test can accurately identify individuals who will progress to AD years before the disease manifests. With Michael on board and Paul\u00b4s continued activities we will be optimally positioned for the upcoming growth phase of Diadem.<\/span><\/p>\n}
<\/p>\n
Mr. Rasche noted, \u201cI am thrilled at the opportunity to lead Diadem as we move to rapidly commercialize the AlzoSure^{\u00ae<\/sup><\/strong> products\u2014a truly innovative approach to improving the management of Alzheimer\u2019s disease. \u00a0Diadem has already amassed an impressive amount of clinical data demonstrating the accuracy and utility of AlzoSure<\/span>^{\u00ae<\/sup><\/strong> as a prognostic test for AD, and our research suggests additional applications as well. I look forward to working with our team and our partners to advance our business and ensure that the benefits of AlzoSure^{\u00ae<\/sup><\/strong> are widely available to relevant stakeholders around the globe.\u201d<\/p>\n}}}
<\/p>\n
Michael Rasche has more than 30 years of leadership experience in high growth international healthcare and life sciences firms across Europe and the Americas. Most recently, he was Chief Commercial Officer at transformational diagnostics firm miDiagnostics. Previously Rasche was President and General Manager of International Business at Metabolon, where he oversaw operations and commercial activities during a period of very rapid growth. At Definiens, an AstraZeneca company, Rasche helped expand the business as Chief Commercial Officer, achieving 50% growth and setting the stage for major partnering agreements. He has also held leadership positions with Ayoxxa, Dako (now part of Agilent), Roche and Bayer Diagnostics.<\/p>\n
<\/p>\n
Diadem\u2019s AlzoSure^{\u00ae<\/sup><\/strong> Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 will experience significant cognitive decline due to Alzheimer\u2019s disease up to six years before the onset of symptoms. Its utility is supported by clinical data from a large longitudinal study that was the basis for AlzoSure^{\u00ae<\/sup><\/strong> Predict\u2019s CE-IVD marking clearance and a Breakthrough Device designation from the U.S. Food & Drug Administration. Diadem has formed a strategic collaboration granting Quest Diagnostics exclusive U.S. rights to the intellectual property of the AlzoSure^{\u00ae<\/sup><\/em> Predict mass spectrometry assay for the purpose of developing, validating and marketing a laboratory-developed test service for U.S. providers and patients.<\/p>\n}}}
<\/p>\n
About AlzoSure^{\u00ae<\/sup> Technology<\/strong><\/p>\n}
AlzoSure^{\u00ae<\/sup> Predict uses a proprietary antibody (U-p53^{AZ<\/sup>) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD<\/a><\/span>.<\/span> The utility of AlzoSure^{\u00ae<\/sup><\/strong> Predict is supported by a large body of clinical data, including}data<\/a><\/span> from a longitudinal study that was the basis for AlzoSure^{\u00ae<\/sup><\/strong> Predict\u2019s Breakthrough Device designation from the U.S. FDA and its CE-IVD marking in the E.U. AlzoSure^{\u00ae<\/sup><\/strong> Predict requires only 1mL of blood to detect the risk of Alzheimer\u2019s disease at the asymptomatic and early symptomatic stage. In addition, the AlzoSure^{\u00ae<\/sup><\/strong> Predict products can identify \u201crapid progressors\u201d at high risk of progressing to Alzheimer\u2019s disease within two years. Diadem is also developing AlzoSure^{\u00ae<\/sup><\/em> Confirm for the differential diagnosis of Alzheimer\u2019s disease and other dementias. AlzoSure^{\u00ae<\/sup> Confirm is a blood-based assay that uses a different set of protein fingerprints to measure levels of the unfolded p53 protein in order to distinguish between and predict whether or not individuals will decline to AD, frontotemporal dementia, Lewy body dementia or Parkinson\u2019s disease-associated dementia. Clinical validation studies are underway.<\/p>\n}}}}}}}
<\/p>\n
About Diadem<\/strong><\/p>\n
Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer\u2019s disease. The lack of accurate, accessible and affordable diagnostic tools has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem\u2019s rapid, accurate and cost-effective AlzoSure^{\u00ae<\/sup><\/strong> Predict blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are potentially achievable. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support adoption and use. The company is also developing AlzoSure^{\u00ae<\/sup> Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit}}diademdx.co.uk<\/a>.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>","tablet":"
Milan, Italy and Secaucus, NJ<\/strong> -- October 25, 2023 \u2013 Diadem SpA, (Diadem), a company developing one of the first blood-based tests for the early and accurate prediction of clinical progression to Alzheimer\u2019s disease (AD), today announced that it has formed a strategic collaboration with Quest Diagnostics (NYSE: DGX), the nation\u2019s leading provider of diagnostic information services, designed to improve access to high quality blood tests for evaluating the risk of Alzheimer\u2019s disease.<\/p>\n
Under terms of the agreement, Diadem has licensed exclusive U.S. rights to the intellectual property of its AlzoSure\u00ae Predict blood-based prognostic technology to Quest for the purpose of developing, validating and marketing a laboratory-developed test service for providers and patients in the U.S. Financial details of the agreement were not disclosed.<\/p>\n
The U.S. Food and Drug Administration granted the AlzoSure\u00ae test Breakthrough Device Designation in January 2022. The test helps identify a variant of the p53 protein that is implicated in AD.<\/p>\n
\"Reliable, convenient and affordable blood tests are essential to the identification of AD risk in early stages, when interventions hold the greatest potential to slow disease progression,\" said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. \"We are encouraged by the clinical research and FDA breakthrough designation for AlzoSure\u00ae and the opportunity to broaden quality and access to AD testing options supporting better patient care.\"<\/p>\n
\u201cWe are delighted to be working with Quest, an industry leader and innovator in novel prognostic and diagnostic tests for Alzheimer's disease, to advance the development and commercialization of test options in the U.S. based on our AlzoSure Predict\u00ae technology,\u201d said Paul Kinnon, Chief Executive Officer of Diadem. \u201cThe decade of work by our researchers and collaborators to clinically validate this important technology is bearing fruit as new therapies and growing knowledge about Alzheimer\u2019s disease are providing hope that early interventions may slow or stop disease progression. We see AlzoSure\u00ae Predict as a potentially valuable contributor in this effort and view Quest as the ideal collaborator to help make the benefits of the AlzoSure\u00ae technology widely available to patients and their healthcare providers as part of Quest\u2019s quality test portfolio.\u201d<\/p>\n
A large body of clinical data supports the utility of Diadem\u2019s AlzoSure\u00ae Predict blood-based technology, suggesting it can help identify whether or not individuals over the age of 50 will experience significant cognitive decline due to Alzheimer\u2019s disease up to six years before the onset of symptoms (area under the curve greater than 98%). Data presented at the Alzheimer\u2019s Association International Conference in July 2023 confirmed the strong prognostic performance of AlzoSure\u00ae Predict based on longitudinal data from 479 individuals aged 60-85 who participated in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study.<\/p>\n
This comprehensive dataset enabled evaluation of the performance of AlzoSure\u00ae Predict in assessing the risk that study participants would experience a significant cognitive decline to Alzheimer\u2019s disease over time, and in identifying the timeframe during which this decline would occur (2 years for \u201crapid progressors\u201d and 6 years for \u201cslow progressors\u201d).<\/p>\n
More than 6 million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Conventional tests for Alzheimer\u2019s involve specialist-delivered PET scans and cerebral spinal fluid testing in symptomatic individuals. New blood tests offer the potential for primary care physicians as well as specialists to identify people at risk for Alzheimer's disease even before symptoms manifest.<\/p>\n
Quest Diagnostics has a long-standing history of advancing diagnostic innovation in the field of dementia, including Alzheimer's disease. The company\u2019s AD-Detect\u2122 portfolio features blood tests to evaluate risk associated with amyloid beta (AB) 42\/40 proteins as well as ApoE genetic risk. The company\u2019s AD-test services also include panels by cerebrospinal fluid (CSF) that help providers assess amyloid beta 42, tau and ApoE status. The company continues to explore the potential of other biomarkers for assessing AD risk that may complement its existing portfolio. For more information, visit Questforthecure.com.<\/p>\n
About AlzoSure\u00ae Predict<\/strong><\/p>\n
AlzoSure\u00ae Predict is a non-invasive biomarker blood-based technology that uses a proprietary antibody (U-p53AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. The utility of AlzoSure\u00ae Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure\u00ae Predict\u2019s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the E.U. AlzoSure\u00ae Predict requires only 1mL of blood to detect the risk of Alzheimer\u2019s disease at the asymptomatic and early symptomatic stage. The AlzoSure\u00ae Predict technology can also identify individuals at high risk of progressing to Alzheimer\u2019s disease within 2 years. Research has also demonstrated that AlzoSure\u00ae Predict can discriminate between the different kinds of dementia with high accuracy.<\/p>\n
About Diadem<\/strong><\/p>\n
Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer\u2019s disease. The lack of accurate, accessible and affordable diagnostic tools has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem\u2019s rapid, accurate and cost-effective AlzoSure\u00ae Predict blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are now potentially achievable. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support adoption and use. Diadem is preparing for commercialisation of AlzoSure\u00ae Predict in collaboration with global strategic partners. The company is also developing AlzoSure\u00ae Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.mywebpreview.co.uk\/.<\/p>","phone":"
Milan, Italy and San Francisco, California, December 5, 2022<\/strong> \u2013 Diadem SpA, a company developing the first blood-based test for the early prediction of progression to Alzheimer\u2019s disease (AD), presented clinical data at the 15^{th<\/sup> Clinical Trials on Alzheimer\u2019s Disease (CTAD) conference highlighting the accuracy and clinical utility of its AlzoSure^{\u00ae<\/sup> Predict prognostic blood test for Alzheimer\u2019s Disease (AD), setting the stage for commercialization in the U.S. beginning in 2023.<\/p>\n\n}}
In the presentation by Diadem Chief Medical Officer Dr. Sam Agus on December 2^{nd<\/sup>, Diadem discussed how AlzoSure^{\u00ae<\/sup> Predict can aid pharmaceutical and biotechnology companies for screening, enrichment and stratification of patient populations to facilitate Alzheimer\u2019s disease clinical trials. Use of the test enables drug developers to identify individuals who will experience a decline to Alzheimer\u2019s dementia up to six years in advance of diagnosis with high confidence, regardless of their cognitive, amyloid, or tau measurement status at the time of testing. This type of patient stratification can improve clinical trial recruitment and the odds of success, as it ensures that patients participating in the trials have a very high probability of developing full-blown AD.<\/p>\n\n}}
Additionally, Dr. Agus discussed the utility of the test as a screening tool to enable physicians and patients to identify those at high risk of developing AD very early in the disease process, when therapies may be most effective. The likely approval of new drugs such as lecanemab from Eisai and Biogen, which shows promising signs of slowing cognitive decline in early AD, highlights the need for accurate and economical screening tools to select patients most likely to benefit from early treatment.<\/p>\n\n
\u201cThis is an exciting time in the battle against Alzheimer\u2019s disease,\u201d said Paul Kinnon, CEO of Diadem. \u201cAdvances in AD diagnosis and therapies are finally providing hope that we can begin to slow or stop the progression of this terrible disease that impacts so many individuals and families. We see AlzoSure^{\u00ae<\/sup> Predict playing a key role in this progress, with its wide potential accessibility and its ability to enhance AD clinical trials and to identify individuals at high risk for progression to AD. As we expected, global market research we are in the process of conducting is showing that both individuals and physicians indicate strong interest in early access to better diagnostic tools for Alzheimer\u2019s.\u201d<\/p>\n\n}
Mr. Kinnon continued, \u201cOur studies show that AlzoSure^{\u00ae<\/sup> Predict is able to predict cognitive decline to AD dementia with an AUC greater than 90%, regardless of the cognitive, amyloid, or tau status of the patient at the time of the test. AlzoSure also showed superiority compared to Pib-PET amyloid imaging in predicting decline to AD dementia in patients before, or with, early signs of cognitive deficits. We now are in the final stages of further validating these findings using longitudinal data from the U.S.-based Alzheimer's Disease Research Centers (ADRC) and Alzheimer\u2019s Disease Neuroimaging Initiative (ADNI) cohorts, and look forward to releasing results in the coming months. We also are preparing for the commercial launch of AlzoSure^{\u00ae<\/sup> Predict in the U.S. in the new year, in collaboration with a major diagnostics partner.\u201d<\/p>\n\n}}
AlzoSure^{\u00ae<\/sup> Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer\u2019s disease up to six years before diagnosis. AlzoSure^{\u00ae<\/sup> Predict uses a proprietary antibody (U-p53^{AZ<\/sup>) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. Previous}}}studies<\/a><\/span> suggest that this p53 variant has utility as a diagnostic and as a predictive biomarker to identify individuals likely to progress to AD up to six years before symptoms appear.<\/p>\n
The utility of AlzoSure^{\u00ae<\/sup> Predict is supported by}clinical data<\/a><\/span> from a large longitudinal study that was the basis for AlzoSure^{\u00ae<\/sup> Predict\u2019s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the EU. AlzoSure^{\u00ae<\/sup> Predict requires only 1mL of blood and 4 to 5 days for analysis to detect AD at the asymptomatic and prodromal (early symptomatic) stage, with an accuracy greater than 95% up to at least 6 years in advance of the clinical onset of symptoms. Previous research also demonstrated that AlzoSure^{\u00ae<\/sup> Predict can discriminate between the different kinds of dementia with high accuracy.<\/p>\n}}}
About Diadem<\/strong><\/p>\n
Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer\u2019s disease. The lack of accurate, accessible and affordable diagnostic tools is a major contributor to the absence of effective treatments for this devastating condition. As a result, patients are not diagnosed until late in the illness, when effective treatment is no longer possible. Diadem\u2019s rapid, accurate and cost-effective blood-based prognostic test makes it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are far more feasible. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support widespread adoption and use. Diadem is preparing for commercialisation of AlzoSure^{\u00ae<\/sup><\/strong> Predict in collaboration with global strategic partners. The company is also developing AlzoSure^{\u00ae<\/sup> Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit}}diademdx.mywebpreview.co.uk\/.<\/a><\/p>"}},"slug":"et_pb_text"}" data-et-multi-view-load-tablet-hidden="true" data-et-multi-view-load-phone-hidden="true">

Milan, Italy – July 10, 2024 – Diadem SpA, (Diadem), a company developing one of the first blood-based tests for the early and accurate prediction of clinical progression to Alzheimer’s disease (AD), today announced that Michael Rasche has been named Chief Executive Officer (CEO) and a member of the Board of Directors. Mr. Rasche brings Diadem more than three decades of experience in driving life sciences innovations to commercial success across Europe and the Americas. The company also announced that former CEO Paul Kinnon will continue to serve on the Diadem SpA board and has been named Chairman of Diadem US, Inc.

Dr. Gerald Möller, Chair of Diadem’s Board of Directors, commented, “I am delighted that Michael will be leading Diadem at this exciting time for the company. Michael’s broad experience spans leadership roles in market development, sales and general management in our industry. His drive, skills and commitment have enabled him to successfully commercialize multiple innovative products. The growing number of therapeutic options for AD highlight the importance of identifying and monitoring Alzheimer’s patients early, with growing evidence that early interventions can slow disease progression. Our AlzoSure^® prognostic test can accurately identify individuals who will progress to AD years before the disease manifests. With Michael on board and Paul´s continued activities we will be optimally positioned for the upcoming growth phase of Diadem.

Mr. Rasche noted, “I am thrilled at the opportunity to lead Diadem as we move to rapidly commercialize the AlzoSure^® products—a truly innovative approach to improving the management of Alzheimer’s disease. Diadem has already amassed an impressive amount of clinical data demonstrating the accuracy and utility of AlzoSure^® as a prognostic test for AD, and our research suggests additional applications as well. I look forward to working with our team and our partners to advance our business and ensure that the benefits of AlzoSure^® are widely available to relevant stakeholders around the globe.”

Michael Rasche has more than 30 years of leadership experience in high growth international healthcare and life sciences firms across Europe and the Americas. Most recently, he was Chief Commercial Officer at transformational diagnostics firm miDiagnostics. Previously Rasche was President and General Manager of International Business at Metabolon, where he oversaw operations and commercial activities during a period of very rapid growth. At Definiens, an AstraZeneca company, Rasche helped expand the business as Chief Commercial Officer, achieving 50% growth and setting the stage for major partnering agreements. He has also held leadership positions with Ayoxxa, Dako (now part of Agilent), Roche and Bayer Diagnostics.

Diadem’s AlzoSure^® Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 will experience significant cognitive decline due to Alzheimer’s disease up to six years before the onset of symptoms. Its utility is supported by clinical data from a large longitudinal study that was the basis for AlzoSure^® Predict’s CE-IVD marking clearance and a Breakthrough Device designation from the U.S. Food & Drug Administration. Diadem has formed a strategic collaboration granting Quest Diagnostics exclusive U.S. rights to the intellectual property of the AlzoSure^® Predict mass spectrometry assay for the purpose of developing, validating and marketing a laboratory-developed test service for U.S. providers and patients.

About AlzoSure^® Technology

AlzoSure^® Predict uses a proprietary antibody (U-p53^AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. The utility of AlzoSure^® Predict is supported by a large body of clinical data, including data from a longitudinal study that was the basis for AlzoSure^® Predict’s Breakthrough Device designation from the U.S. FDA and its CE-IVD marking in the E.U. AlzoSure^® Predict requires only 1mL of blood to detect the risk of Alzheimer’s disease at the asymptomatic and early symptomatic stage. In addition, the AlzoSure^® Predict products can identify “rapid progressors” at high risk of progressing to Alzheimer’s disease within two years. Diadem is also developing AlzoSure^® Confirm for the differential diagnosis of Alzheimer’s disease and other dementias. AlzoSure^® Confirm is a blood-based assay that uses a different set of protein fingerprints to measure levels of the unfolded p53 protein in order to distinguish between and predict whether or not individuals will decline to AD, frontotemporal dementia, Lewy body dementia or Parkinson’s disease-associated dementia. Clinical validation studies are underway.

About Diadem

Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer’s disease. The lack of accurate, accessible and affordable diagnostic tools has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem’s rapid, accurate and cost-effective AlzoSure^® Predict blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are potentially achievable. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support adoption and use. The company is also developing AlzoSure^® Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.co.uk.

Corporate:

Diadem

Michael Rasche

CEO

execadmin@diademdx.co.uk

Media

Barbara Lindheim

BLL Partners for Diadem

blindheim@bllbiopartners.com

+1 (917) 355-9234

The post Diadem Appoints Michael Rasche as Chief Executive Officer appeared first on Diadem DX.

Diadem SpA Announces Exclusive U.S. Licensing Agreement with Quest Diagnostics for Its AlzoSure® Predict Alzheimer’s Disease Prognostic Technology

clairenicholson078 — Wed, 25 Oct 2023 11:23:01 +0000

Diadem SpA Announces Exclusive U.S. Licensing Agreement with Quest Diagnostics for Its AlzoSure® Predict Alzheimer’s Disease Prognostic Technology

—Quest to Develop and Market a Lab-developed Test Based on the IP of AlzoSure Predict® in the United States, Extending its Industry-leading Portfolio of Alzheimer’s Disease Blood Tests—

—Validating Clinical Data Suggests that AlzoSure® Predict’s Blood-Based Technology Can Help Identify Whether or Not Individuals Will Progress to Alzheimer’s Disease Up to 6 Years Before Diagnosis.

<\/p>\n
Milan, Italy and Secaucus, NJ<\/strong> — October 25, 2023 \u2013 Diadem SpA, (Diadem), a company developing one of the first blood-based tests for the early and accurate prediction of clinical progression to Alzheimer\u2019s disease (AD), today announced that it has formed a strategic collaboration with Quest Diagnostics (NYSE: DGX), the nation\u2019s leading provider of diagnostic information services, designed to improve access to high quality blood tests for evaluating the risk of Alzheimer\u2019s disease.<\/p>\n
Under terms of the agreement, Diadem has licensed exclusive U.S. rights to the intellectual property of its AlzoSure\u00ae Predict blood-based prognostic technology to Quest for the purpose of developing, validating and marketing a laboratory-developed test service for providers and patients in the U.S. Financial details of the agreement were not disclosed.<\/p>\n
The U.S. Food and Drug Administration granted the AlzoSure\u00ae test Breakthrough Device Designation in January 2022. The test helps identify a variant of the p53 protein that is implicated in AD.<\/p>\n
“Reliable, convenient and affordable blood tests are essential to the identification of AD risk in early stages, when interventions hold the greatest potential to slow disease progression,” said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. “We are encouraged by the clinical research and FDA breakthrough designation for AlzoSure\u00ae and the opportunity to broaden quality and access to AD testing options supporting better patient care.”<\/p>\n
\u201cWe are delighted to be working with Quest, an industry leader and innovator in novel prognostic and diagnostic tests for Alzheimer’s disease, to advance the development and commercialization of test options in the U.S. based on our AlzoSure Predict\u00ae technology,\u201d said Paul Kinnon, Chief Executive Officer of Diadem. \u201cThe decade of work by our researchers and collaborators to clinically validate this important technology is bearing fruit as new therapies and growing knowledge about Alzheimer\u2019s disease are providing hope that early interventions may slow or stop disease progression. We see AlzoSure\u00ae Predict as a potentially valuable contributor in this effort and view Quest as the ideal collaborator to help make the benefits of the AlzoSure\u00ae technology widely available to patients and their healthcare providers as part of Quest\u2019s quality test portfolio.\u201d<\/p>\n
A large body of clinical data supports the utility of Diadem\u2019s AlzoSure\u00ae Predict blood-based technology, suggesting it can help identify whether or not individuals over the age of 50 will experience significant cognitive decline due to Alzheimer\u2019s disease up to six years before the onset of symptoms (area under the curve greater than 98%). Data presented at the Alzheimer\u2019s Association International Conference in July 2023 confirmed the strong prognostic performance of AlzoSure\u00ae Predict based on longitudinal data from 479 individuals aged 60-85 who participated in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study.<\/p>\n
This comprehensive dataset enabled evaluation of the performance of AlzoSure\u00ae Predict in assessing the risk that study participants would experience a significant cognitive decline to Alzheimer\u2019s disease over time, and in identifying the timeframe during which this decline would occur (2 years for \u201crapid progressors\u201d and 6 years for \u201cslow progressors\u201d).<\/p>\n
More than 6 million Americans have Alzheimer’s, the most prevalent dementia, a number projected to reach 14 million by 2060. Conventional tests for Alzheimer\u2019s involve specialist-delivered PET scans and cerebral spinal fluid testing in symptomatic individuals. New blood tests offer the potential for primary care physicians as well as specialists to identify people at risk for Alzheimer’s disease even before symptoms manifest.<\/p>\n
Quest Diagnostics has a long-standing history of advancing diagnostic innovation in the field of dementia, including Alzheimer’s disease. The company\u2019s AD-Detect\u2122 portfolio features blood tests to evaluate risk associated with amyloid beta (AB) 42\/40 proteins as well as ApoE genetic risk. The company\u2019s AD-test services also include panels by cerebrospinal fluid (CSF) that help providers assess amyloid beta 42, tau and ApoE status. The company continues to explore the potential of other biomarkers for assessing AD risk that may complement its existing portfolio. For more information, visit Questforthecure.com.<\/p>\n
About AlzoSure\u00ae Predict<\/strong><\/p>\n
AlzoSure\u00ae Predict is a non-invasive biomarker blood-based technology that uses a proprietary antibody (U-p53AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. The utility of AlzoSure\u00ae Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure\u00ae Predict\u2019s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the E.U. AlzoSure\u00ae Predict requires only 1mL of blood to detect the risk of Alzheimer\u2019s disease at the asymptomatic and early symptomatic stage. The AlzoSure\u00ae Predict technology can also identify individuals at high risk of progressing to Alzheimer\u2019s disease within 2 years. Research has also demonstrated that AlzoSure\u00ae Predict can discriminate between the different kinds of dementia with high accuracy.<\/p>\n
About Diadem<\/strong><\/p>\n
Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer\u2019s disease. The lack of accurate, accessible and affordable diagnostic tools has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem\u2019s rapid, accurate and cost-effective AlzoSure\u00ae Predict blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are now potentially achievable. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support adoption and use. Diadem is preparing for commercialisation of AlzoSure\u00ae Predict in collaboration with global strategic partners. The company is also developing AlzoSure\u00ae Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.co.uk.<\/p>","tablet":"
Milan, Italy and Secaucus, NJ<\/strong> -- October 25, 2023 \u2013 Diadem SpA, (Diadem), a company developing one of the first blood-based tests for the early and accurate prediction of clinical progression to Alzheimer\u2019s disease (AD), today announced that it has formed a strategic collaboration with Quest Diagnostics (NYSE: DGX), the nation\u2019s leading provider of diagnostic information services, designed to improve access to high quality blood tests for evaluating the risk of Alzheimer\u2019s disease.<\/p>\n
Under terms of the agreement, Diadem has licensed exclusive U.S. rights to the intellectual property of its AlzoSure\u00ae Predict blood-based prognostic technology to Quest for the purpose of developing, validating and marketing a laboratory-developed test service for providers and patients in the U.S. Financial details of the agreement were not disclosed.<\/p>\n
The U.S. Food and Drug Administration granted the AlzoSure\u00ae test Breakthrough Device Designation in January 2022. The test helps identify a variant of the p53 protein that is implicated in AD.<\/p>\n
\"Reliable, convenient and affordable blood tests are essential to the identification of AD risk in early stages, when interventions hold the greatest potential to slow disease progression,\" said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. \"We are encouraged by the clinical research and FDA breakthrough designation for AlzoSure\u00ae and the opportunity to broaden quality and access to AD testing options supporting better patient care.\"<\/p>\n
\u201cWe are delighted to be working with Quest, an industry leader and innovator in novel prognostic and diagnostic tests for Alzheimer's disease, to advance the development and commercialization of test options in the U.S. based on our AlzoSure Predict\u00ae technology,\u201d said Paul Kinnon, Chief Executive Officer of Diadem. \u201cThe decade of work by our researchers and collaborators to clinically validate this important technology is bearing fruit as new therapies and growing knowledge about Alzheimer\u2019s disease are providing hope that early interventions may slow or stop disease progression. We see AlzoSure\u00ae Predict as a potentially valuable contributor in this effort and view Quest as the ideal collaborator to help make the benefits of the AlzoSure\u00ae technology widely available to patients and their healthcare providers as part of Quest\u2019s quality test portfolio.\u201d<\/p>\n
A large body of clinical data supports the utility of Diadem\u2019s AlzoSure\u00ae Predict blood-based technology, suggesting it can help identify whether or not individuals over the age of 50 will experience significant cognitive decline due to Alzheimer\u2019s disease up to six years before the onset of symptoms (area under the curve greater than 98%). Data presented at the Alzheimer\u2019s Association International Conference in July 2023 confirmed the strong prognostic performance of AlzoSure\u00ae Predict based on longitudinal data from 479 individuals aged 60-85 who participated in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study.<\/p>\n
This comprehensive dataset enabled evaluation of the performance of AlzoSure\u00ae Predict in assessing the risk that study participants would experience a significant cognitive decline to Alzheimer\u2019s disease over time, and in identifying the timeframe during which this decline would occur (2 years for \u201crapid progressors\u201d and 6 years for \u201cslow progressors\u201d).<\/p>\n
More than 6 million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Conventional tests for Alzheimer\u2019s involve specialist-delivered PET scans and cerebral spinal fluid testing in symptomatic individuals. New blood tests offer the potential for primary care physicians as well as specialists to identify people at risk for Alzheimer's disease even before symptoms manifest.<\/p>\n
Quest Diagnostics has a long-standing history of advancing diagnostic innovation in the field of dementia, including Alzheimer's disease. The company\u2019s AD-Detect\u2122 portfolio features blood tests to evaluate risk associated with amyloid beta (AB) 42\/40 proteins as well as ApoE genetic risk. The company\u2019s AD-test services also include panels by cerebrospinal fluid (CSF) that help providers assess amyloid beta 42, tau and ApoE status. The company continues to explore the potential of other biomarkers for assessing AD risk that may complement its existing portfolio. For more information, visit Questforthecure.com.<\/p>\n
About AlzoSure\u00ae Predict<\/strong><\/p>\n
AlzoSure\u00ae Predict is a non-invasive biomarker blood-based technology that uses a proprietary antibody (U-p53AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. The utility of AlzoSure\u00ae Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure\u00ae Predict\u2019s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the E.U. AlzoSure\u00ae Predict requires only 1mL of blood to detect the risk of Alzheimer\u2019s disease at the asymptomatic and early symptomatic stage. The AlzoSure\u00ae Predict technology can also identify individuals at high risk of progressing to Alzheimer\u2019s disease within 2 years. Research has also demonstrated that AlzoSure\u00ae Predict can discriminate between the different kinds of dementia with high accuracy.<\/p>\n
About Diadem<\/strong><\/p>\n
Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer\u2019s disease. The lack of accurate, accessible and affordable diagnostic tools has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem\u2019s rapid, accurate and cost-effective AlzoSure\u00ae Predict blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are now potentially achievable. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support adoption and use. Diadem is preparing for commercialisation of AlzoSure\u00ae Predict in collaboration with global strategic partners. The company is also developing AlzoSure\u00ae Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.mywebpreview.co.uk\/.<\/p>","phone":"
Milan, Italy and San Francisco, California, December 5, 2022<\/strong> \u2013 Diadem SpA, a company developing the first blood-based test for the early prediction of progression to Alzheimer\u2019s disease (AD), presented clinical data at the 15^{th<\/sup> Clinical Trials on Alzheimer\u2019s Disease (CTAD) conference highlighting the accuracy and clinical utility of its AlzoSure^{\u00ae<\/sup> Predict prognostic blood test for Alzheimer\u2019s Disease (AD), setting the stage for commercialization in the U.S. beginning in 2023.<\/p>\n\n}}
In the presentation by Diadem Chief Medical Officer Dr. Sam Agus on December 2^{nd<\/sup>, Diadem discussed how AlzoSure^{\u00ae<\/sup> Predict can aid pharmaceutical and biotechnology companies for screening, enrichment and stratification of patient populations to facilitate Alzheimer\u2019s disease clinical trials. Use of the test enables drug developers to identify individuals who will experience a decline to Alzheimer\u2019s dementia up to six years in advance of diagnosis with high confidence, regardless of their cognitive, amyloid, or tau measurement status at the time of testing. This type of patient stratification can improve clinical trial recruitment and the odds of success, as it ensures that patients participating in the trials have a very high probability of developing full-blown AD.<\/p>\n\n}}
Additionally, Dr. Agus discussed the utility of the test as a screening tool to enable physicians and patients to identify those at high risk of developing AD very early in the disease process, when therapies may be most effective. The likely approval of new drugs such as lecanemab from Eisai and Biogen, which shows promising signs of slowing cognitive decline in early AD, highlights the need for accurate and economical screening tools to select patients most likely to benefit from early treatment.<\/p>\n\n
\u201cThis is an exciting time in the battle against Alzheimer\u2019s disease,\u201d said Paul Kinnon, CEO of Diadem. \u201cAdvances in AD diagnosis and therapies are finally providing hope that we can begin to slow or stop the progression of this terrible disease that impacts so many individuals and families. We see AlzoSure^{\u00ae<\/sup> Predict playing a key role in this progress, with its wide potential accessibility and its ability to enhance AD clinical trials and to identify individuals at high risk for progression to AD. As we expected, global market research we are in the process of conducting is showing that both individuals and physicians indicate strong interest in early access to better diagnostic tools for Alzheimer\u2019s.\u201d<\/p>\n\n}
Mr. Kinnon continued, \u201cOur studies show that AlzoSure^{\u00ae<\/sup> Predict is able to predict cognitive decline to AD dementia with an AUC greater than 90%, regardless of the cognitive, amyloid, or tau status of the patient at the time of the test. AlzoSure also showed superiority compared to Pib-PET amyloid imaging in predicting decline to AD dementia in patients before, or with, early signs of cognitive deficits. We now are in the final stages of further validating these findings using longitudinal data from the U.S.-based Alzheimer's Disease Research Centers (ADRC) and Alzheimer\u2019s Disease Neuroimaging Initiative (ADNI) cohorts, and look forward to releasing results in the coming months. We also are preparing for the commercial launch of AlzoSure^{\u00ae<\/sup> Predict in the U.S. in the new year, in collaboration with a major diagnostics partner.\u201d<\/p>\n\n}}
AlzoSure^{\u00ae<\/sup> Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer\u2019s disease up to six years before diagnosis. AlzoSure^{\u00ae<\/sup> Predict uses a proprietary antibody (U-p53^{AZ<\/sup>) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. Previous studies<\/a><\/span> suggest that this p53 variant has utility as a diagnostic and as a predictive biomarker to identify individuals likely to progress to AD up to six years before symptoms appear.<\/p>\n}}}
The utility of AlzoSure^{\u00ae<\/sup> Predict is supported by}clinical data<\/a><\/span> from a large longitudinal study that was the basis for AlzoSure^{\u00ae<\/sup> Predict\u2019s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the EU. AlzoSure^{\u00ae<\/sup> Predict requires only 1mL of blood and 4 to 5 days for analysis to detect AD at the asymptomatic and prodromal (early symptomatic) stage, with an accuracy greater than 95% up to at least 6 years in advance of the clinical onset of symptoms. Previous research also demonstrated that AlzoSure^{\u00ae<\/sup> Predict can discriminate between the different kinds of dementia with high accuracy.<\/p>\n}}}
About Diadem<\/strong><\/p>\n
Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer\u2019s disease. The lack of accurate, accessible and affordable diagnostic tools is a major contributor to the absence of effective treatments for this devastating condition. As a result, patients are not diagnosed until late in the illness, when effective treatment is no longer possible. Diadem\u2019s rapid, accurate and cost-effective blood-based prognostic test makes it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are far more feasible. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support widespread adoption and use. Diadem is preparing for commercialisation of AlzoSure^{\u00ae<\/sup><\/strong> Predict in collaboration with global strategic partners. The company is also developing AlzoSure^{\u00ae<\/sup> Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit}}diademdx.mywebpreview.co.uk\/.<\/a><\/p>"}},"slug":"et_pb_text"}" data-et-multi-view-load-tablet-hidden="true" data-et-multi-view-load-phone-hidden="true">

Milan, Italy and Secaucus, NJ — October 25, 2023 – Diadem SpA, (Diadem), a company developing one of the first blood-based tests for the early and accurate prediction of clinical progression to Alzheimer’s disease (AD), today announced that it has formed a strategic collaboration with Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, designed to improve access to high quality blood tests for evaluating the risk of Alzheimer’s disease.

Under terms of the agreement, Diadem has licensed exclusive U.S. rights to the intellectual property of its AlzoSure® Predict blood-based prognostic technology to Quest for the purpose of developing, validating and marketing a laboratory-developed test service for providers and patients in the U.S. Financial details of the agreement were not disclosed.

The U.S. Food and Drug Administration granted the AlzoSure® test Breakthrough Device Designation in January 2022. The test helps identify a variant of the p53 protein that is implicated in AD.

“Reliable, convenient and affordable blood tests are essential to the identification of AD risk in early stages, when interventions hold the greatest potential to slow disease progression,” said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. “We are encouraged by the clinical research and FDA breakthrough designation for AlzoSure® and the opportunity to broaden quality and access to AD testing options supporting better patient care.”

“We are delighted to be working with Quest, an industry leader and innovator in novel prognostic and diagnostic tests for Alzheimer’s disease, to advance the development and commercialization of test options in the U.S. based on our AlzoSure Predict® technology,” said Paul Kinnon, Chief Executive Officer of Diadem. “The decade of work by our researchers and collaborators to clinically validate this important technology is bearing fruit as new therapies and growing knowledge about Alzheimer’s disease are providing hope that early interventions may slow or stop disease progression. We see AlzoSure® Predict as a potentially valuable contributor in this effort and view Quest as the ideal collaborator to help make the benefits of the AlzoSure® technology widely available to patients and their healthcare providers as part of Quest’s quality test portfolio.”

A large body of clinical data supports the utility of Diadem’s AlzoSure® Predict blood-based technology, suggesting it can help identify whether or not individuals over the age of 50 will experience significant cognitive decline due to Alzheimer’s disease up to six years before the onset of symptoms (area under the curve greater than 98%). Data presented at the Alzheimer’s Association International Conference in July 2023 confirmed the strong prognostic performance of AlzoSure® Predict based on longitudinal data from 479 individuals aged 60-85 who participated in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study.

This comprehensive dataset enabled evaluation of the performance of AlzoSure® Predict in assessing the risk that study participants would experience a significant cognitive decline to Alzheimer’s disease over time, and in identifying the timeframe during which this decline would occur (2 years for “rapid progressors” and 6 years for “slow progressors”).

More than 6 million Americans have Alzheimer’s, the most prevalent dementia, a number projected to reach 14 million by 2060. Conventional tests for Alzheimer’s involve specialist-delivered PET scans and cerebral spinal fluid testing in symptomatic individuals. New blood tests offer the potential for primary care physicians as well as specialists to identify people at risk for Alzheimer’s disease even before symptoms manifest.

Quest Diagnostics has a long-standing history of advancing diagnostic innovation in the field of dementia, including Alzheimer’s disease. The company’s AD-Detect™ portfolio features blood tests to evaluate risk associated with amyloid beta (AB) 42/40 proteins as well as ApoE genetic risk. The company’s AD-test services also include panels by cerebrospinal fluid (CSF) that help providers assess amyloid beta 42, tau and ApoE status. The company continues to explore the potential of other biomarkers for assessing AD risk that may complement its existing portfolio. For more information, visit Questforthecure.com.

About AlzoSure® Predict

AlzoSure® Predict is a non-invasive biomarker blood-based technology that uses a proprietary antibody (U-p53AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. The utility of AlzoSure® Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure® Predict’s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the E.U. AlzoSure® Predict requires only 1mL of blood to detect the risk of Alzheimer’s disease at the asymptomatic and early symptomatic stage. The AlzoSure® Predict technology can also identify individuals at high risk of progressing to Alzheimer’s disease within 2 years. Research has also demonstrated that AlzoSure® Predict can discriminate between the different kinds of dementia with high accuracy.

About Diadem

Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer’s disease. The lack of accurate, accessible and affordable diagnostic tools has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem’s rapid, accurate and cost-effective AlzoSure® Predict blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are now potentially achievable. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support adoption and use. Diadem is preparing for commercialisation of AlzoSure® Predict in collaboration with global strategic partners. The company is also developing AlzoSure® Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.co.uk.

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Understanding treatment pathways for Alzheimer’s Disease

clairenicholson078 — Mon, 24 Jul 2023 12:42:09 +0000

Understanding treatment pathways for Alzheimer’s Disease

In the realm of neurological disorders, Alzheimer’s Disease (AD) stands as one of the most challenging and devastating conditions of our time. With its progressive nature and profound impact on memory, cognition, and daily functioning, AD poses significant hurdles for both patients and their loved ones. As the global population ages, the prevalence of this disease continues to rise, further emphasizing the pressing need for effective treatment pathways.

This blog looks at all the factors that must be considered when determining a treatment pathway for patients, as well as the drugs used to treat those with AD.

Alzheimer’s Disease (AD) is diagnosed as a set of clinical features, such as cognitive dysfunction, behavioral alterations, and functional decline. But it is also viewed as a continuum of states, spanning from normal cognition to advanced and severe dementia.

Treating individuals with AD is a multi-disciplinary endeavor as it should consider the disease state of the patient which is governed by multiple factors:

Where the patient is on the AD continuum

What issues are driving most of the burden

Goals of the treatment

Co-morbidities

Concomitant medications

Lifestyle

Environment

So when making decisions about AD treatment, there are several important factors to be considered – is there sufficient support for the patient and caregiver, are there any adjustments for the environment needed including where they live, and who can support them during the treatment , are there any changes needed to the patient’s lifestyle, as well as addressing risk-factors of the treatment and providing AD-specific medications.

Current drugs used to treat AD

AD-specific medications include drugs which target brain neurotransmitter imbalance – these include choline esterase inhibitors (ChEi) and NMDA-receptor antagonists used both individually and in combination and are approved for the treatment of patients with established dementia.

In the past two years, the FDA has granted an approval, under an accelerated process, for two medications, which are based on antibodies to beta-amyloid, which is a toxic substance that accumulates in the brain of patients with AD. These treatments have received approval under an accelerated process.
These drugs were tested in large studies and initial analysis showed that patients that were on treatment deteriorated less than those on placebo. But these treatments are associated with amyloid-related imaging abnormalities (ARIA) in the form of brain edema and hemorrhage, and in rare cases, an increased risk of mortality.

On July 6, one of these medications, lecanemab (Lequembi) has received final approval from the FDA for the treatment of patients with mild cognitive impairment (MCI) and mild dementia. But before administration, patients should be tested for their ApoE status as the subtype ApoE4 is linked to a higher risk of ARIA. In addition, administration of lecanemab to patients who are receiving anticoagulation is also associated with an increased risk for ARIA in the form of brain hemorrhage
. Data from a large clinical trial with another medication of the same class, is very promising, with the expectation that it will also be approved soon.

Navigating the treatment plans for AD

Despite ongoing research efforts, a definitive cure for AD remains elusive. However, there is a growing body of knowledge surrounding various treatment modalities and strategies that can help manage symptoms, slow down disease progression, and enhance the quality of life for individuals living with AD. Understanding these treatment pathways is crucial for patients, caregivers, and healthcare professionals alike, enabling them to make informed decisions and provide the best possible care.

References

[1] Aisen PS, Cummings J, Jack CR Jr, Morris JC, Sperling R, Frölich L, Jones RW, Dowsett SA, Matthews BR, Raskin J, Scheltens P, Dubois B. On the path to 2025: understanding the Alzheimer’s disease continuum. Alzheimers Res Ther. 2017 Aug 9;9(1):60. doi: 10.1186/s13195-017-0283-5. PMID: 28793924; PMCID: PMC5549378.

[1] Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer’s disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018. PMID: 29653606; PMCID: PMC5958625

[1] Atri A. The Alzheimer’s Disease Clinical Spectrum: Diagnosis and Management. Med Clin North Am. 2019 Mar;103(2):263-293. doi: 10.1016/j.mcna.2018.10.009. PMID: 30704681.

[1] https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval

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