FDA Clears Blood Test to Assist in Alzheimer’s Diagnosis

The Food and Drug Administration (FDA) has approved a new blood test aimed at aiding the diagnosis of Alzheimer’s disease. This test, known as PrecivityAD2, is expected to be released later this year. Developed by C2N Diagnostics, the test targets adults aged 40 and older who show signs of cognitive impairment. It works alongside clinical evaluations and is not meant as a standalone or screening tool. This marks the first test the FDA has authorized for symptomatic individuals in this age group, according to C2N Diagnostics.

Currently, Alzheimer’s disease is the most prevalent form of dementia, accounting for 60 to 80 percent of cases, as per the Alzheimer’s Association. Around 7.4 million Americans aged 65 and older are affected, with estimates predicting an increase to 13.8 million by 2060.

Alzheimer’s is progressive, with patients typically living four to eight years after diagnosis. However, some may live for up to 20 years. A 2026 study in Alzheimer’s & Dementia journal indicated that reported deaths from this disease surged by 134 percent between 2000 and 2024.

Current Detection Methods

The disease’s development is linked to two proteins, beta-amyloid and tau, which are believed to damage brain nerve cells. This damage results in symptoms such as memory failure, mood changes, and difficulties with daily tasks. Diagnosis involves evaluating symptoms and obtaining information from family members.

Early indicators of Alzheimer’s can include memory loss, concentration issues, poor judgment, mood changes, and confusion. Clinicians may decide to conduct laboratory tests and brain imaging based on observed symptoms.

Functionality of the Blood Test

C2N Diagnostics’ blood test identifies brain amyloid plaques linked to Alzheimer’s. In a study with over 1,000 participants, the test showed a 97.6 percent accuracy rate for positive results and a 93.1 percent rate for negatives. This reflects its effectiveness across various degrees of cognitive impairment.

Dr. Joel Braunstein, C2N Co-Founder, CEO, and President, stated: “The FDA clearance is a significant moment for our company and the Alzheimer’s community.” He highlighted the test’s potential to simplify the complex diagnostic pathway for patients with memory issues.

Implications for Alzheimer’s Diagnosis

This blood test allows diagnosis without needing a PET scan, offering quicker results. Research suggests utilizing multiple biomarker tests can expedite the commencement of amyloid-targeting treatments. C2N Diagnostics believes their test enables faster diagnostic and treatment processes.