PrecivityAD2 expansion addresses clinician demand for earlier detection of cognitive symptoms, backed by JAMA study showing over 90% accuracy.
C2N Diagnostics has expanded the intended use of its PrecivityAD2 Alzheimer’s disease blood test to include patients 50 years and older, lowering the previous age limit from 60 years to address increasing demand from clinicians seeking earlier detection options.
The blood test helps detect amyloid plaques in the brain, a pathological hallmark of Alzheimer’s disease, and supports medical management and treatment decisions. The company completed additional validation studies to support the expanded age range for patients born in 1975 and before.
“We’ve been working diligently to meet the need for easy, accessible, and affordable blood tests for those patients and families who want answers in their early 50s, and we’re proud we’ve reached this milestone,” says Dr Joel Braunstein, C2N CEO, in a release. “We recognize that patients with mild cognitive impairment due to Alzheimer’s disease are very eager to access the new disease-modifying therapies, and scientists have stated these therapies are most successful when they start early.”
JAMA Study Validates Performance Across Age Groups
The expansion follows publication of a large clinical study in the Journal of the American Medical Association examining the PrecivityAD2 test’s ability to improve diagnostic accuracy in primary care settings. The study involving over 1,200 patients demonstrated over 90% accuracy at a pre-defined, single binary cutoff compared to cerebrospinal fluid analysis or amyloid PET analysis.
The research showed similar performance for patients who saw memory care specialists and demonstrated effectiveness for those between ages 50 and 55. Results remained consistent despite a relatively high rate of medical comorbidities including cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes among enrolled patients in both primary and secondary care settings.
The study, titled “Blood Biomarkers to Detect Alzheimer’s Disease in Primary Care and Secondary Care,” provides clinical validation for the test’s expanded age range and supports its use in diverse patient populations.
Global Availability and Quality Standards
The Precivity tests are available in 49 US states, excluding New York where certification is pending, as well as the District of Columbia and Puerto Rico. C2N has signed additional global partners to expand access in Asia, Latin America, Europe and the Middle East.
The revised intended use for patients 50 and older has been incorporated into the MHRA Medical Device Certification in the United Kingdom, which C2N announced earlier this year.
C2N’s Precivity tests are performed under ISO 13485:2016 standards in the company’s CAP-accredited, CLIA-certified laboratory. According to Braunstein, C2N technology was used in clinical trials of some current therapies available to patients with early Alzheimer’s disease.
The expansion addresses a significant diagnostic gap, as Alzheimer’s Disease International reports that 75% of all dementia cases go undiagnosed globally, with the figure rising to 90% in developing countries. C2N believes the expanded age range can help reduce these numbers by providing earlier access to diagnostic testing.
