Over 90% Accuracy: FDA Clears New Blood Test for Early Alzheimer’s Detection

The U.S. Food and Drug Administration (FDA) has cleared a new blood test designed to detect Alzheimer’s disease at an early stage, according to News Medical Live Sciences.

The PrecivityAD2 test was developed and validated by C2N Diagnostics, a startup founded by researchers from Washington University School of Medicine in St. Louis. The test is based on technology originally developed by scientists at the university and is designed to identify amyloid plaques in the brain, one of the key biological hallmarks of Alzheimer’s disease.

Unlike some other FDA-cleared blood tests that rely on immunoassay techniques, PrecivityAD2 uses high-precision mass spectrometry to quantitatively measure several Alzheimer’s-related biomarkers.

A blood test is considerably less invasive than cerebrospinal fluid analysis and could make it easier to evaluate patients experiencing cognitive problems. Early diagnosis is becoming increasingly important as treatments capable of slowing Alzheimer’s progression are now available and tend to work more effectively when started at an earlier stage.

The technology behind PrecivityAD2 was initially developed by a team at Washington University School of Medicine led by neurologists Randall Bateman and David Holtzman. In 2007, the researchers and their colleagues co-founded C2N Diagnostics, which obtained exclusive commercial rights to patented technologies developed in their laboratories.

PrecivityAD2 measures the ratio of two forms of amyloid-beta, Aβ42 and Aβ40, along with two forms of tau protein, p-tau217 and total tau217. These biomarkers are associated with the pathological changes that occur in the brain in Alzheimer’s disease.

Previous studies have shown that the test can identify amyloid pathology with more than 90% accuracy and performs comparably to more invasive approaches, including cerebrospinal fluid testing and brain imaging, even in people with mild cognitive impairment.

The FDA clearance expands the test’s potential role in clinical practice. Physicians had already been able to order PrecivityAD2 for patients with mild cognitive symptoms, but the new regulatory decision could make it easier for more health care institutions to adopt and promote the test under FDA-cleared use. It may also facilitate insurance coverage, potentially making the analysis more accessible to patients.

Research conducted by Bateman and Holtzman has also contributed to the development of methods for studying how amyloid-beta is produced and cleared from the brain and cerebrospinal fluid. Their work helped establish the scientific foundation for today’s blood-based biomarkers for Alzheimer’s disease.

Follow NEWS.am Medicine on Facebook and Twitter