What's Happening?
C2N Diagnostics has announced the validation of its PrecivityAD2 blood test, which is designed to detect brain amyloid pathology in patients with cognitive impairment. The test combines plasma Aβ42/40 and %p-tau217 biomarkers into the Amyloid Probability Score (APS2) algorithm, achieving 91% accuracy, 90% sensitivity, and 92% specificity. This development aligns with the 2025 Alzheimer's Association's Clinical Practice Guidelines, which recommend confirmatory blood biomarker tests. The test is available in 49 U.S. states, excluding New York, and in the District of Columbia and Puerto Rico.
Why It's Important?
The validation of the PrecivityAD2 test is significant as it offers a non-invasive, accurate method for diagnosing Alzheimer's disease, potentially improving early detection and treatment outcomes. This is crucial as new disease-modifying therapies are most effective when administered early. The test's availability across most of the U.S. and its alignment with clinical guidelines could lead to widespread adoption, benefiting patients and healthcare providers by streamlining the diagnostic process and reducing reliance on more invasive procedures like amyloid PET imaging.
What's Next?
C2N plans to expand the availability of the PrecivityAD2 test globally, having signed partnerships in Asia, Latin America, Europe, and the Middle East. The company will continue to collaborate with pharmaceutical and biotech firms, academic institutions, and non-profits to further research and development in Alzheimer's diagnostics and treatment. As the test gains traction, it may influence clinical practices and healthcare policies related to Alzheimer's disease management.
