C2N Diagnostics has widened the intended use of its PrecivityAD2™ Alzheimer’s disease blood test to include patients aged 50 and older, down from its previous threshold of 60, according to the company. This expansion follows successful additional validation studies, the company said, now allowing clinicians to prescribe the test for individuals born in 1975 or earlier. The blood test assists healthcare professionals in detecting amyloid plaques—key indicators of Alzheimer’s pathology—and informs clinical management and treatment decisions.
The revised indication is grounded in research published in the Journal of the American Medical Association, which demonstrated the test’s diagnostic accuracy of over 90 percent against benchmarks such as cerebrospinal fluid analysis and amyloid PET scans. These findings held true even among patients with significant comorbidities—including cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes—across both primary and specialist care settings. The study also confirmed the test’s reliability specifically for the 50- to 55-year-old cohort, the company claims.
C2N Diagnostics added that this broadened age range has now been incorporated into its UK MHRA Medical Device Certification. The PrecivityAD2™ test is currently available across 49 U.S. states (excluding New York, pending certification), as well as in the District of Columbia and Puerto Rico. The company also recently partnered with international organizations to extend access to Asia, Latin America, Europe, and the Middle East. All testing is conducted in a CAP-accredited, CLIA-certified laboratory under the ISO 13485:2016 standard.
