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

Rhea-AI Summary

Diadem forms strategic collaboration with Quest Diagnostics to develop and market a blood-based test for Alzheimer's disease. The test has Breakthrough Device Designation and can identify a variant of the p53 protein implicated in AD. The collaboration aims to improve access to high-quality blood tests for evaluating AD risk.

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• Diadem forms strategic collaboration with Quest Diagnostics to develop and market a blood-based test for Alzheimer's disease
• The test has Breakthrough Device Designation and can identify a variant of the p53 protein implicated in AD
• The collaboration aims to improve access to high-quality blood tests for evaluating AD risk

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• None.

—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—

MILAN and SECAUCUS, N.J., Oct. 25, 2023 /PRNewswire/ -- 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-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 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.com/.

Contacts:
Diadem Media:	Quest Media:
Barbara Lindheim	Jen Petrella (Media)
BLL Partners for Diadem	973-520-2800
blindheim@bllbiopartners.com	Shawn Bevec (Investors)
+1 (917) 355-9234	973-520-2900

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SOURCE Diadem SpA

FAQ

What is the collaboration between Diadem and Quest Diagnostics?

Diadem and Quest Diagnostics have formed a strategic collaboration to develop and market a blood-based test for Alzheimer's disease.

What is the significance of the Breakthrough Device Designation for the test?

The test has received Breakthrough Device Designation from the U.S. Food and Drug Administration, indicating its potential to provide significant benefits for patients with Alzheimer's disease.

What can the test identify?

The test can identify a variant of the p53 protein that is implicated in Alzheimer's disease.

What is the goal of the collaboration?

The collaboration aims to improve access to high-quality blood tests for evaluating the risk of Alzheimer's disease.

How many Americans have Alzheimer's disease?

More than 6 million Americans have Alzheimer's disease, and this number is projected to reach 14 million by 2060.

What other tests does Quest Diagnostics offer for Alzheimer's disease?

Quest Diagnostics offers blood tests to evaluate risk associated with amyloid beta (AB) 42/40 proteins and ApoE genetic risk, as well as panels by cerebrospinal fluid (CSF) that help assess amyloid beta 42, tau, and ApoE status.