FDA Clears Blood Tests to Aid Alzheimer Disease Diagnosis

The U.S. Food and Drug Administration has cleared marketing for innovative blood-based diagnostic tests, including C2N Diagnostics' PrecivityAD2 and a test developed by Roche and Eli Lilly, to aid in the evaluation of Alzheimer's disease.

The regulatory decisions provide clinicians with less invasive screening tools to detect amyloid pathology and brain plaques associated with Alzheimer's disease in patients presenting with cognitive symptoms such as memory loss.

The PrecivityAD2 test relies on underlying technology co-invented at Washington University School of Medicine in St. Louis by Dr. Randall J.

Bateman and Dr. David M. Holtzman.

The test utilizes high-resolution mass spectrometry to analyze biomarker ratios of amyloid and tau proteins in blood plasma.

In clinical evaluation, PrecivityAD2 demonstrated over 90% accuracy in identifying brain amyloid pathology, performing comparably to traditional spinal taps and brain scans even among patients exhibiting mild symptoms.

"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," said Dr. Randall J. Bateman, professor of neurology at Washington University School of Medicine.

Bateman noted that the clearance enables broader clinical access for individuals seeking answers for cognitive decline, allowing patients to begin treatment earlier when therapeutic options offer maximum effectiveness.

"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," Bateman said.

FDA clearance allows C2N Diagnostics to market the test directly to healthcare systems and facilitates insurance coverage, lowering financial barriers for patients. C2N Diagnostics was originally co-founded in 2007 to commercialize the patented technologies developed in university laboratories.

"Achieving FDA clearance of the PrecivityAD2 blood test is a key milestone in our mission to transform the diagnosis and management of Alzheimer's disease on a path toward finding a cure," said Dr. David M. Holtzman, professor in the Department of Neurology at Washington University.

The technological breakthrough follows years of foundational research into amyloid-beta and tau protein kinetics, led by Bateman and Holtzman in collaboration with the university's technology management office.

"This accomplishment reflects the unwavering, yearslong commitment of everyone on our team and the team at C2N Diagnostics to delivering innovative solutions that improve lives," Holtzman said.

University leaders highlighted the role of academic research in advancing diagnostic tools that address previously untreatable neurodegenerative conditions.

"The FDA clearance of C2N's blood test is a significant advancement in Alzheimer's diagnostics and a testament to the culture of innovation at WashU Medicine," said Dr. Doug E. Frantz, vice chancellor for innovation and commercialization at Washington University.

Frantz added that precise diagnostic tools remain critical for supporting ongoing development of targeted therapies.

"Accurate and accessible tools like this are critical in supporting our mission to accelerate the development of treatments and cures for Alzheimer's and other diseases once thought to be untreatable," Frantz said.

In a parallel decision, the FDA cleared the Elecsys Phospho-Tau Plasma test, developed jointly by Roche and Eli Lilly. That blood test identifies amyloid pathology in individuals aged 55 and older using immunoassay biomarker detection.