In a move that could help drastically slow the advancement of Alzheimer's disease (AD), the US Food and Drug Administration (FDA) has cleared C2N Diagnostics' PrecivityAD2 blood test for patients as young as 40 who have shown some potential cognitive symptoms of the condition.
It's the first blood test cleared by the FDA to test for AD in people this young.
PrecivityAD2 is a single blood test that quickly assesses the proteins amyloid and tau, using mass spectrometry to measure plasma Aβ42/40 and p-tau217/np-tau217. The results are then scored, qualifying as negative, likely positive, or positive for AD.
“Just over a year ago, there were no FDA-cleared blood tests for Alzheimer’s, and now we have three,” Isobel Coleman, chief executive officer of the Alzheimer's Drug Discovery Foundation (ADDF), said in a statement. "This is a proof point that sustained, early investment in translational science plays a catalytic role in moving promising ideas from the lab to patients.”
In a recent clinical validation study, 1,142 symptomatic adults were tested using PrecivityAD2. The process accurately identified 97.6% of positive biomarkers. What's more, the results remained consistent even in patients with comorbidities like chronic kidney disease and diabetes, which can distort plasma amyloid samples.
It's worth noting that the test isn't intended for general health screenings, but for patients who already show some cognitive decline.
"As PrecivityAD2 and tools like it move further into clinical practice, they will enable earlier detection, sharpen clinical trials, and build the foundation for precision medicine and combination therapies," Coleman added.
It's been accepted in the medical science community that AD takes root in the brain years before symptoms begin to show. Before such blood tests became available, patients underwent either PET imaging or painful lumbar puncture to access cerebrospinal fluid.
According to the US Alzheimer's Association, some 7.4 million Americans aged 65 and older are living with AD, and an estimated 200,000 more have younger-onset disease.
The test was created by researchers at Washington University School of Medicine in St. Louis, and then further developed and validated by C2N Diagnostics, a WashU startup.
The technology behind the test was developed by a team co-led by Randall J. Bateman, MD, and David M. Holtzman, MD, in the Department of Neurology.
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.”
Source: WashU Medicine
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