FDA Approves First Alzheimer’s Blood Test For Americans As Young As 40

The FDA has cleared the first Alzheimer’s blood test for symptomatic patients as young as 40. The test measures amyloid and tau biomarkers from a single blood draw and identified positive biomarkers with 97.6% accuracy in a validation study. PrecivityAD2 is a single blood test that quickly assesses the proteins amyloid and tau, using mass spectrometry to measure plasma AB42/40 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.