The US Food and Drug Administration has granted clearance to C2N Diagnostics' PrecivityAD2 blood test, marking the first such authorization for symptomatic adults aged 40 and older. The test detects amyloid plaques to aid clinical diagnosis but is not a standalone screening tool.

The U.S. Food and Drug Administration has cleared the PrecivityAD2 test for adults 40 and older presenting with signs or symptoms of cognitive impairment and undergoing evaluation for Alzheimer's disease or other forms of cognitive decline.

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.

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 y...

The biomarker test, called PrecivityAD2, was developed from technology invented at WashU Medicine by Randall J. Bateman, MD, and David M. Holtzman, MD.

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 y...

La Food and Drug Administration (FDA) statunitense ha autorizzato la commercializzazione di un innovativo test del sangue, basato su una tecnologia inventata presso la Washington University School of Medicine di St. Louis, per la diagnosi precoce del morbo di Alzheimer. Il test, denominato PrecivityAD2, è stato sviluppato e validato da C2N Diagnostics, una startup nata all'interno della WashU. PrecivityAD2 è un test diagnostico ematico approvato dalla FDA per aiutare a identificare la presenza di placche amiloidi nel cervello associate alla malattia di Alzheimer in alcuni pazienti.

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. New Atlas reports: PrecivityAD2 is a single blood test th...

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 y...

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. New Atlas reports: PrecivityAD2 is a single blood test th...

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. New Atlas reports: 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. Read more of this story at Slashdot.

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. New Atlas reports: 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. Read more of this story at Slashdot.

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 y...

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. New Atlas reports: PrecivityAD2 is a single blood test th...

The blood-based biomarker test is based on technology developed at WashU Medicine by Randall Bateman, MD, and David Holtzman, MD.

Un análisis de sangre reemplaza a la punción lumbar La FDA aprobó el 20 de agosto de 2026 el uso clínico de PrecivityAD2, un análisis de sangre desarrollado por

A blood test replaces the lumbar puncture The FDA approved on August 20, 2026, the clinical use of PrecivityAD2, a blood test developed by C2N Diagnostics along

The U.S. Food and Drug Administration (FDA) has cleared an innovative blood test for marketing. The test's underlying technology was invented at Washington University School of Medicine in St. Louis for the early diagnosis of Alzheimer's disease. The test, known as PrecivityAD2, was developed and validated by C2N Diagnostics, a WashU startup.