Alzheimer’s Drug Discovery Foundation Announces Major Funding Commitment to Validate an Amyloid Blood Test for Non-Invasive Early Detection of Alzheimer’s

C2N Diagnostics’ PrecivityAD™ blood test carries an FDA Breakthrough Device Designation; earlier studies report test is highly reliable in predicting presence of brain amyloid

The Alzheimer’s Drug Discovery Foundation (ADDF) announced today that it has awarded more than $2.2 million to C2N Diagnostics to accelerate clinical validation and accreditation of its beta-amyloid blood test for early detection of Alzheimer’s disease pathology. The ADDF has been a long-time supporter of research into Alzheimer’s biomarkers, including this amyloid blood test, providing $2.8 million in funding to C2N over the last decade.

“Investing in biomarker research has been a core goal for the ADDF because having reliable, accessible and affordable biomarkers for Alzheimer’s diagnosis is step one in finding drugs to prevent, slow and even cure the disease,” said Howard Fillit, M.D., Founding Executive Director and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation. “This test answers a critical need for less costly and more accessible diagnostic testing in memory and dementia care.”

C2N’s PrecivityAD will soon be a widely available blood test for Alzheimer’s detection in people who are experiencing new onset memory loss. The company’s St. Louis lab will begin processing tests prescribed by physicians and delivering results to aid in the diagnostic work-up process. The test involves a very small blood sample (as little as a teaspoon) from the arm. The latest ADDF funding will help C2N gather important data needed to further advance the test’s acceptability across a broad population.

“Our lab is in the final stages of becoming a clinical diagnostic laboratory, which means the PrecivityAD test will be available for doctors to order for their patients. While Alzheimer’s disease currently has no cure, the sooner a person knows about the likelihood of this disease, the earlier doctors are able to explore treatment options for that individual. We are at a breakthrough moment in understanding and treating this terrible disease and are honored with the trust and confidence of the ADDF,” said Joel B. Braunstein, M.D., CEO of C2N.

The PrecivityAD test uses mass spectrometry to measure the concentrations of Amyloid beta 42 and 40 (Aß42 and Aß40) and the presence of APOE isoforms (genetic markers for Alzheimer’s disease) in the blood. The test can detect how likely it is that an individual has brain amyloidosis, a pathological hallmark of Alzheimer’s disease. As part of C2N’s commitment to developing a comprehensive Brain Health Panel™, the test is helping to detect memory loss and brain aging at the earliest stages. This will enable effective prevention and early treatment strategies for people at risk of the disease. Additional markers of Alzheimer’s disease, including p-tau217, are currently in development at C2N’s lab.

Early seed funding from the ADDF led to the first FDA-approved diagnostic test for Alzheimer’s disease in 2012, the Amyvid™ PET brain scan. This scan has been scientifically revolutionary and has changed the way clinical trials are done, but its high costs and lack of coverage by Medicare have limited its use in clinical practice. The PrecivityAD blood test, by contrast, has the power to revolutionize patient care and clinical trials. “The cost of Alzheimer’s phase 3 trials is $300 million to $400 million with half of that devoted to screening and enrollment,” according to Dr. Fillit. “This test will dramatically reduce those costs and the time it takes to screen patients for clinical trials. The availability of a blood test for Alzheimer’s disease will change clinical practice.”