The Food and Drug Administration (FDA) has approved a blood test named PrecivityAD2 to aid in diagnosing Alzheimer’s disease. Developed by C2N Diagnostics, the test targets adults aged 40 and older who show signs of cognitive impairment while undergoing assessment for Alzheimer’s. However, the test is to be used alongside clinical evaluation, not as a standalone diagnostic tool or screening method.
This test marks the FDA’s first approval for use in symptomatic adults in this age group, according to C2N Diagnostics. Newsweek has reached out to both the FDA and C2N Diagnostics for further comments beyond regular working hours.
Alzheimer’s disease, a form of dementia, is prevalent, making up 60 to 80 percent of dementia cases, as stated by the Alzheimer’s Association. Currently, it’s estimated that 7.4 million Americans aged 65 and older are living with Alzheimer’s, a figure that may rise to 13.8 million by 2060. The disease progresses over time, with patients typically living four to eight years following diagnosis, though some may survive up to 20 years. A study in Alzheimer’s & Dementia noted that reported deaths from Alzheimer’s increased by 134 percent from 2000 to 2024.
Current Detection Methods for Alzheimer’s
The accumulation of beta-amyloid and tau proteins in the brain contributes to Alzheimer’s disease, as these proteins damage nerve cells. This damage results in memory loss, personality changes, difficulty in daily tasks, and other symptoms.
Diagnosing Alzheimer’s involves reviewing symptoms and often consulting with family members. Early indicators include memory loss, concentration challenges, poor judgment, mood changes, communication difficulties, and confusion.
Clinicians may then conduct various laboratory tests and brain imaging scans based on observed symptoms and their severity.
Understanding the Blood Test
C2N Diagnostics’ blood test aims to detect brain amyloid plaques, strengthening and informing a clinical assessment. These plaques stem from the beta-amyloid protein linked to Alzheimer’s. In a study with over 1,000 participants, the test showed a positive predictive value of 97.6 percent and a negative predictive value of 93.1 percent.
The test effectively detects amyloid plaques across a range of cognitive impairments, including mild and advanced cases. Dr. Joel Braunstein, Co-Founder, CEO, and President of C2N, called the FDA approval a significant milestone for Alzheimer’s research and diagnostics.
The PrecivityAD2 test is seen as pivotal in simplifying the diagnostic path for patients facing serious memory issues.
Implications for Alzheimer’s Treatment
C2N Diagnostics suggests the test offers timely answers about Alzheimer’s without needing a PET scan. Recent studies highlight the potential of using multiple biomarker tests to expedite patient treatment for amyloid-targeting therapies, by simplifying and accelerating the diagnostic process.
The new blood test aims to allow patients to receive diagnoses and begin treatments more rapidly, enhancing overall Alzheimer’s care.