Roche and Eli Lilly Alzheimer's blood test receives FDA clearance

Alzheimer's disease blood test FDA clearance pTau217 biomarker

The U.S. Food and Drug Administration (FDA) has cleared the Elecsys pTau217 blood test, developed by Roche in collaboration with Eli Lilly, to assist in identifying Alzheimer’s disease pathology. The test is indicated for symptomatic individuals aged 55 and older experiencing cognitive decline, helping clinicians determine the likelihood of amyloid pathology.

This single-biomarker assay is designed to be used in both primary and specialty care settings. It can be performed on more than 4,500 Roche laboratory analyzers already installed across the United States, facilitating rapid nationwide scaling. Major laboratory networks, including Quest Diagnostics and Labcorp, have announced plans to offer the test through their services.

Quest Diagnostics also announced two additional developments: the launch of a new multi-biomarker AD-Detect test combining ABeta 42/40, p-tau217, and ApoE evaluation, and plans to introduce the Roche-based Elecsys pTau217 test to its portfolio in the fourth quarter of 2026, with further integration into broader panels by 2027.

Additionally, the FDA has cleared the PrecivityAD2 blood test from C2N Diagnostics, which is indicated for symptomatic patients as young as 40. In clinical studies, the PrecivityAD2 test demonstrated 97.6% accuracy for positive results.

Entities

Alzheimer's Drug Discovery Foundation · C2N Diagnostics · Eli Lilly · Eli Lilly and Company · FDA · Quest Diagnostics · Roche

Claims

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

[● 4 SOURCES] Fujirebio’s Lumipulse was the first blood test cleared by the FDA for Alzheimer's assessment in 2025. abc17news.com · arynews.tv · keyt.com · localnews8.com
[DISPUTED] The FDA cleared the Roche and Eli Lilly Elecsys pTau217 blood test for individuals aged 55 and older with cognitive decline. abc17news.com · arynews.tv · hitconsultant.net · keyt.com · localnews8.com · +5 more
[● 2 SOURCES] Quest Diagnostics intends to integrate the Roche test into its AD-Detect panels in 2027. aijourn.com · www.stocktitan.net
[● 3 SOURCES] Quest Diagnostics plans to offer the Roche-based Elecsys pTau217 test nationwide in the fourth quarter of 2026. aijourn.com · www.stocktitan.net · clpmag.com
[● 2 SOURCES] The C2N Diagnostics PrecivityAD2 blood test demonstrated 97.6% accuracy for positive results in a study of 1,142 subjects. www.it-boltwise.de · science.slashdot.org
[● 3 SOURCES] Quest Diagnostics is launching a new multi-biomarker AD-Detect test combining ABeta 42/40, p-tau217, and ApoE evaluation. www.stocktitan.net · clpmag.com · aijourn.com
[● 5 SOURCES] The Elecsys pTau217 test can be performed on over 4,500 Roche laboratory analyzers currently installed in the U.S. abc17news.com · arynews.tv · hitconsultant.net · keyt.com · localnews8.com
[DISPUTED] The FDA has cleared blood tests for Alzheimer's that can be used for symptomatic patients as young as 40. science.slashdot.org · www.it-boltwise.de