Dive Brief:
- The Food and Drug Administration has cleared a new blood test from Roche and Eli Lilly for assessments to both rule in and rule out Alzheimer’s disease, Roche said Monday. The Elecsys pTau217 test received Europe’s CE mark in May.
- The single biomarker blood test aids in identifying amyloid pathology associated with Alzheimer's in people age 55 and older with signs of cognitive decline. The test may help clinicians assess the likelihood of amyloid pathology earlier in the diagnostic pathway and identify patients who should be considered for further evaluation, Roche said.
- Labcorp and Quest Diagnostics both said Monday that they plan to offer the new test.
Dive Insight:
Phosphorylated Tau 217 has emerged as a leading biomarker in the assessment of Alzheimer's disease, according to Labcorp.
In May 2025, the FDA cleared Fujirebio’s Lumipulse, which compares the ratio of the proteins pTau217 and beta-amyloid, as the first in vitro diagnostic blood test to aid in diagnosing Alzheimer’s. Labcorp and Quest began selling laboratory-developed tests for the same biomarkers earlier that year.
Last week, the FDA cleared C2N Diagnostics’ PrecivityAD2 blood test for people age 40 and older, to help diagnose Alzheimer’s. Based on technology developed at Washington University School of Medicine in St. Louis, the biomarker test uses mass spectrometry to measure ratios of amyloid and two forms of tau protein in the blood. C2N expects its test to be available later this year; a lab-developed version remains available.
Leerink Partners analysts said the C2N and Roche-Lilly test launches signal rising competition as the assays attempt to drive broader adoption in the market. “We finally see momentum with [Alzheimer’s diagnostics],” the analysts wrote to clients Monday.
The Elecsys pTau217 test promotes consistency by using the same validated clinical cutoffs across primary care and specialty settings, Roche said. Traditional approaches for assessing amyloid pathology such as positron emission tomography, or PET, imaging and cerebrospinal fluid, or CSF, testing are more difficult to access outside of specialty centers.
Roche said it designed the test for use with its Cobas lab instruments to support broad access and rapid implementation.
Labcorp plans to make the test available nationwide in the coming months. The company noted that while several pTau217 assays are commercially available, standardization across care settings is an important consideration for clinicians. The performance of the Roche-Lilly test is comparable to CSF testing and PET imaging, Labcorp said.
Quest said it plans to introduce a lab test service based on the Elecsys pTau217 assay under its AD-Detect brand nationwide in the fourth quarter. Quest also plans to incorporate the test in future AD-Detect panels in 2027.
