FDA clears two new blood tests for Alzheimer's detection

Alzheimer's disease blood test FDA clearance biomarkers cognitive decline

The U.S. Food and Drug Administration (FDA) has cleared two new blood tests designed to detect signs of Alzheimer's disease, offering a less invasive alternative to spinal fluid exams and PET scans.

C2N Diagnostics received approval for the PrecivityAD2 test, which can be used by individuals aged 40 and older experiencing cognitive complaints. The test analyzes amyloid and tau proteins via mass spectrometry, with clinical studies reporting an accuracy rate of 97.6 percent.

Additionally, the FDA cleared the Elecsys pTau-217 test, developed through a partnership between Roche and Eli Lilly. This test is intended for individuals aged 55 and older showing signs of cognitive decline. It is the first to measure a single biomarker, plasma phosphorylated tau 217, and is compatible with over 4,500 analyzers across the United States.

These advancements follow a previous 2025 clearance of a Fujirebio Diagnostics test. While these blood tests represent significant progress in making diagnostics more accessible, medical experts note that they should not be used as a sole definitive diagnosis without clinical context.

Entities

C2N Diagnostics · Eli Lilly · FDA · Fujirebio Diagnostics · Roche

Claims

What the coverage asserts, and how many sources carry each claim.

[○ 1 SOURCE] The FDA approved the PrecivityAD2 blood test for individuals aged 40 and older with cognitive complaints. www.yenicaggazetesi.com
[○ 1 SOURCE] The Elecsys pTau-217 test can be used on more than 4,500 analyzers across the United States. www.yenicaggazetesi.com
[○ 1 SOURCE] The PrecivityAD2 test achieved an accuracy rate of 97.6 percent in clinical validation studies involving 142 adults. www.yenicaggazetesi.com
[○ 1 SOURCE] The Elecsys pTau-217 test is the first to measure a single biomarker to assess Alzheimer's. nemosnewsnetwork.com
[● 2 SOURCES] The FDA cleared the Elecsys pTau-217 blood test for individuals aged 55 and older showing signs of cognitive decline. nemosnewsnetwork.com · www.yenicaggazetesi.com
[● 2 SOURCES] Fujirebio Diagnostics received FDA approval for a test measuring both pTau217 and another protein. nemosnewsnetwork.com · www.yenicaggazetesi.com

Sources

FDA Clears Blood Test To Detect Signs Of Alzheimer’s Disease [nemosnewsnetwork.com]

15 days ago

Belden sıvı alma dönemi bitiyor: Artık kan testiyle alzheimer tespiti mümkün [www.gazetebirlik.com]

17 days ago

Durchbruch bei Alzheimer-Bluttest: Was sich für Patienten künftig ändern könnte [www.berliner-kurier.de]

14 days ago

Alzheimer teşhisinde devrim niteliğinde gelişme: ABD'den iki yeni kan testine yeşil ışık [www.yenicaggazetesi.com]

15 days ago