FDA clears blood test to aid evaluation for Alzheimer’s disease – WashU Medicine

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The U.S. Food and Drug Administration (FDA) has cleared for marketing an innovative blood test with underlying technology invented at Washington University School of Medicine in St. Louis for the early diagnosis of Alzheimer’s disease. The test, known as PrecivityAD2, was developed and validated by C2N Diagnostics, a WashU startup company.

PrecivityAD2 is a blood-based diagnostic test cleared by the FDA to aid in identifying the presence of amyloid plaques in the brain associated with Alzheimer’s disease in certain patients. Unlike some other FDA-cleared blood-based tests that use immunoassay methods to analyze biomarkers associated with Alzheimer’s, PrecivityAD2 uses high-resolution mass spectrometry to provide quantitative measurements of the biomarkers.

The availability of blood-based biomarker testing may help clinicians evaluate patients for Alzheimer’s disease using a less invasive approach than cerebrospinal fluid testing. Biomarker information may also help inform appropriate clinical management when interpreted together with a patient’s clinical history and other diagnostic information.

Early detection of Alzheimer’s disease is important since the first treatments capable of slowing the progression of the neurodegenerative disease recently became available to patients, and these drugs are more effective when started sooner rather than later. Other promising investigational drugs are in the pipeline.

Fundamental technology underlying the test was initially developed by a WashU Medicine team co-led by Randall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology, and David M. Holtzman, MD, the Barbara Burton and Reuben M. Morriss III Distinguished Professor in the Department of Neurology. C2N Diagnostics is a WashU startup co-founded by Bateman, Holtzman and others in 2007. C2N acquired exclusive commercial license rights to the patented technologies developed in Bateman’s and Holtzman’s labs, and optimized and commercialized assays underpinning some of the tests developed by Bateman’s team.

“The PrecivityAD2 test provides an accurate and reliable way to detect the presence of brain amyloid plaques associated with Alzheimer’s disease pathology based on a single blood draw,” Bateman said. “With FDA clearance, this innovation can reach more patients, increasing early and accurate diagnoses for people who are seeking causes of cognitive symptoms such as memory loss. With faster diagnosis, patients can receive earlier treatment, when treatments are most effective.”

Randy Bateman, MD, talks with research technician Olatayo Ajenifuja about Alzheimer’s Disease research in his lab.<br>" data-large-file="https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-700x467.jpg" class="size-large wp-image-136085" src="https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-700x467.jpg" alt="Randall Bateman in his lab with another scientist" width="700" height="467" srcset="https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-700x467.jpg 700w, https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-300x200.jpg 300w, https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-600x400.jpg 600w, https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-186x124.jpg 186w, https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-220x147.jpg 220w, https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-413x275.jpg 413w, https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM-825x550.jpg 825w, https://medicine.washu.edu/app/uploads/2026/08/20240104_BatemanLab_0272-4.04.55-PM.jpg 1200w" sizes="(max-width: 700px) 100vw, 700px" />Matt Miller/WashU Medicine<br>WashU Medicine’s Randall Bateman, MD, (right) is a co-founder of C2N Diagnostics, a WashU startup that received FDA clearance for its PrecivityAD2 test to aid in Alzheimer’s evaluation.

FDA clearance signifies that PrecivityAD2 has undergone rigorous evaluation to confirm it has comparable accuracy to cerebrospinal fluid tests and brain scans, even in patients with mild symptoms. Although physicians have been able to order the PrecivityAD2 test for patients with...