The Food and Drug Administration (FDA) has approved a blood test intended to assist in diagnosing Alzheimer’s disease, with its release expected later this year. This test, named PrecivityAD2, is developed by C2N Diagnostics and targets adults 40 years and older exhibiting signs or symptoms of cognitive impairment. The test will complement clinical evaluations, aiding healthcare professionals in identifying Alzheimer’s but is not meant to be used alone as a standalone diagnostic tool.
PrecivityAD2 is the first test cleared by the FDA for symptomatic adults aged 40 and above, as confirmed by C2N Diagnostics. Newsweek sought comments from the FDA and C2N Diagnostics via email outside regular business hours.
Alzheimer’s disease ranks as the most prevalent form of dementia, accounting for 60 to 80 percent of cases, according to the Alzheimer’s Association. Data shows approximately 7.4 million Americans aged 65 and older currently live with Alzheimer’s, and projections suggest the figure could climb to 13.8 million by 2060. The disease is progressive, with life expectancy after diagnosis ranging from four to eight years, though some individuals may survive for up to 20 years. A study from 2026 published in ‘Alzheimer’s & Dementia’ recorded a 134 percent increase in reported Alzheimer’s-related deaths from 2000 to 2024.
Detecting Alzheimer’s Disease
Alzheimer’s development is linked to the accumulation of two proteins in the brain—beta-amyloid and tau. These proteins are believed to degrade nerve cells, resulting in memory loss, personality changes, difficulty in performing daily activities, and other associated symptoms. Diagnosis typically involves healthcare professionals reviewing a patient’s symptoms and consulting family members.
Early symptoms include memory loss, concentration difficulties, poor judgment, mood swings, communication challenges, and confusion. Based on symptom evaluation, clinicians may choose to conduct various laboratory tests or brain imaging scans for precise diagnosis.
Functionality of the Blood Test
The blood test by C2N Diagnostics is engineered to detect brain amyloid plaques, which can provide further support and detail in clinical assessments. A clinical validation study involving over 1,000 participants showed the test had a 97.6 percent positive predictive value for a positive outcome and a 93.1 percent negative predictive value for a negative result.
C2N Diagnostics reported that the test effectively identifies amyloid plaques at various stages of cognitive impairment, including mild to advanced symptoms. Dr. Joel Braunstein, Co-Founder, CEO, and President, stated, “The FDA clearance is a watershed moment for our company, the whole Alzheimer’s disease community, molecular diagnostics, and precision medicine.” The PrecivityAD2 test is expected to simplify the complex diagnostic pathway patients face when encountering serious memory issues.
Implications for Alzheimer’s Patients
C2N Diagnostics claims the test allows a timely Alzheimer’s diagnosis without requiring a PET scan. Research indicates that employing multiple high-performing biomarker tests can potentially accelerate the start of amyloid-targeting treatments. Consequently, this blood test might help patients get diagnosed and begin treatment more swiftly.
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