FDA Approves New Alzheimer’s Blood Test: PrecivityAD2

The Food and Drug Administration (FDA) has recently given clearance to a new blood test aimed at aiding in the diagnosis of Alzheimer’s disease. Expected to be available later this year, this test, known as PrecivityAD2, was developed by C2N Diagnostics for adults aged 40 years and older who display signs or symptoms of cognitive impairment during assessments for Alzheimer’s disease.

PrecivityAD2 is intended to be used alongside clinical evaluations to help healthcare professionals identify patients with Alzheimer’s. It is not designed to be a standalone test or screening tool. As stated by C2N Diagnostics, this is the first FDA-cleared test for symptomatic adults aged 40 and above.

The Alzheimer’s Association reports Alzheimer’s as the most common form of dementia, responsible for 60 to 80 percent of cases. Currently, around 7.4 million Americans aged 65 and older are estimated to live with Alzheimer’s, with projections suggesting this could increase to 13.8 million by 2060.

Alzheimer’s disease is progressive; patients typically live between four to eight years post-diagnosis, though some may survive up to 20 years. A study from 2026 published in ‘Alzheimer’s & Dementia’ showed reported deaths from Alzheimer’s increased by 134 percent between 2000 and 2024.

How Is Alzheimer’s Currently Detected?

The buildup of beta-amyloid and tau proteins in the brain is believed to damage nerve cells, leading to Alzheimer’s. The destruction of these cells results in memory loss, changes in personality, difficulty in daily tasks, and other symptoms.

To diagnose Alzheimer’s, a healthcare professional examines the patient’s symptoms and often consults with family members. Early symptoms include memory lapses, concentration issues, poor judgment, mood changes, communication struggles, and confusion. Based on symptoms and severity, clinicians may decide on laboratory tests and brain imaging scans.

How Does The Blood Test Work?

Developed by C2N Diagnostics, PrecivityAD2 detects amyloid plaques in the brain to support clinical assessments. These plaques stem from beta-amyloid protein buildup linked to Alzheimer’s disease. In a clinical study involving 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 efficiently detects amyloid plaques across various stages of cognitive impairment. Dr. Joel Braunstein, C2N’s Co-Founder, CEO, and President, stated that FDA clearance marks a pivotal moment for C2N, the Alzheimer’s community, and the field of molecular diagnostics and precision medicine.

He emphasized the test’s potential in simplifying the diagnostic process for patients experiencing serious memory concerns.

What Does This Mean for Alzheimer’s?

C2N Diagnostics highlights the test’s capability to provide timely answers about Alzheimer’s disease, eliminating the need for PET scans. Instead, it employs multiple high-performing biomarker tests that could delay the time it takes for patients to start amyloid targeting treatments. The blood test is anticipated to allow faster diagnosis and treatment initiation for patients.