The Food and Drug Administration (FDA) has approved a new blood test called PrecivityAD2, which aids in diagnosing Alzheimer’s disease. Developed by C2N Diagnostics, this test targets adults aged 40 and older showing cognitive impairment symptoms. It complements clinical assessments and is not intended to function as a standalone test or screening tool.
C2N Diagnostics noted that PrecivityAD2 is the first test cleared by the FDA for symptomatic adults in this age group. The test identifies patients with Alzheimer’s, the leading cause of dementia, which affects 60 to 80 percent of those diagnosed. Currently, around 7.4 million Americans aged 65 and over are living with Alzheimer’s, with projections indicating a rise to 13.8 million by the year 2060.
Alzheimer’s disease progresses, often leading to a life expectancy of four to eight years post-diagnosis, though some individuals may live for up to 20 years. Alzheimer’s & Dementia journal reported a significant increase in deaths related to Alzheimer’s, up by 134 percent from 2000 to 2024.
How Is Alzheimer’s Currently Detected?
The build-up of beta-amyloid and tau proteins in the brain is considered a primary contributor to nerve cell damage, leading to Alzheimer’s. This destruction results in symptoms such as memory loss, personality changes, and reduced ability to conduct daily activities.
Healthcare professionals diagnose Alzheimer’s by evaluating patient symptoms and obtaining information from family members. Initial signs include memory loss, concentration difficulties, poor judgment, mood changes, communication issues, and confusion. Depending on the symptoms’ severity, clinicians may order laboratory tests and brain imaging scans.
How Does The Blood Test Work?
C2N Diagnostics developed a blood test that identifies amyloid plaques in the brain, supporting clinical assessments. These plaques originate from the beta-amyloid protein linked to Alzheimer’s. A clinical validation study involving over 1,000 participants showed the test had a positive predictive value of 97.6 percent and a negative predictive value of 93.1 percent.
The test effectively detects amyloid plaques across various cognitive impairment cases, from mild to severe. Dr. Joel Braunstein, Co-Founder, CEO, and President of C2N, stated that FDA clearance marks significant progress for the Alzheimer’s community and precision medicine. The test aims to streamline diagnostic procedures for memory concerns.
What Does This Mean for Alzheimer’s?
C2N Diagnostics claimed that the test offers a quicker alternative to a PET scan by providing answers on Alzheimer’s disease in less time. Recent studies suggest that using multiple biomarker tests rather than relying on one may reduce delays in initiating amyloid-targeting treatments. Consequently, the new blood test can expedite diagnosis and treatment commencement.
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