Diadem SpA (Diadem), a company developing a blood-based test for the early and accurate prediction of clinical progression to Alzheimer’s disease (AD), has formed a strategic collaboration with Quest Diagnostics 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.

“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,” says Kathleen Valentine, VP 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.”

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.

“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,” says Paul Kinnon, CEO 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.”

Further reading: Quest Launches Consumer-Initiated Blood Test for Alzheimer’s Risk Assessment

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%), the company says. 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 (two years for “rapid progressors” and six 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 history of advancing diagnostic innovation in the field of dementia, including Alzheimer’s disease, according to the company. The company’s AD-Detect portfolio features blood tests to evaluate the 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.