FDA clears PrecivityAD2 blood test for Alzheimer's diagnosis

The US Food and Drug Administration (FDA) has cleared the PrecivityAD2 blood test for marketing, marking a significant step in the early diagnosis of Alzheimer's disease. The test, developed by C2N Diagnostics, provides a less invasive method for clinicians to evaluate patients with cognitive symptoms, moving away from more traditional and intrusive diagnostic procedures.

C2N Diagnostics, a startup co-founded in 2007 by Washington University School of Medicine researchers Randall Bateman and David Holtzman, utilises high-resolution mass spectrometry to measure specific biomarkers in the blood. Unlike other FDA-cleared tests that rely on immunoassay methods, PrecivityAD2 offers quantitative measurements of amyloid and tau protein ratios, specifically Aβ42 and 40, as well as p-tau217 and total tau217.

According to previous studies, the test demonstrates more than 90% accuracy in diagnosing the amyloid pathology associated with Alzheimer's disease. It performs comparably to more invasive screening methods, such as cerebrospinal fluid testing and brain scans, even in patients presenting with mild cognitive symptoms. This level of precision allows for earlier intervention, which is critical as new treatments capable of slowing disease progression have recently become available.

FDA clearance signifies that the test has undergone rigorous evaluation to confirm its reliability. This regulatory status allows C2N Diagnostics to market the test more broadly to clinicians and health systems that rely on FDA quality assurance standards. Furthermore, the clearance may facilitate insurance coverage, potentially making the test more affordable and accessible to patients seeking answers for memory loss and other cognitive issues.

The underlying technology was invented at Washington University School of Medicine in St. Louis, where Bateman and Holtzman pioneered methods for precisely measuring Alzheimer's-associated proteins. Their foundational research, including stable isotope-linked kinetics approaches, contributed to the scientific basis for blood-based biomarker technologies. C2N Diagnostics acquired exclusive commercial license rights to these patented technologies to optimise and commercialise the assays.

C2N Diagnostics currently employs more than 120 professionals and is expanding its headquarters to St. Louis' Cortex Innovation District, a campus adjacent to Washington University School of Medicine. The company's vice chancellor for innovation and commercialisation, Doug E. Frantz, described the clearance as a testament to the institution's culture of innovation and a critical tool in accelerating the development of treatments for neurodegenerative diseases.