Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test

MedTech Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test By Ben Adams Aug 24, 2026 8:15am Roche Eli Lilly Alzheimer's disease Diagnostics Roche and Eli Lilly have won FDA clearance for their latest Alzheimer’s disease diagnostic. The Elecsys pTau217, developed by Roche in conjunction with Lilly, is a blood test designed to detect phosphorylated Tau (pTau) 217 protein, a hallmark of Alzheimer’s disease that has been linked to the presence of amyloid plaque buildup in the brain. High levels indicate a greater likelihood that a patient has Alzheimer’s disease, while low levels can help rule out the disease in those experiencing cognitive impairment.

The test can be used across primary and secondary care settings and is designed for those ages 55 years or older with signs, symptoms or complaints of cognitive decline associated with Alzheimer's disease. Related Labcorp launches Roche's FDA-cleared Alzheimer's blood test Roche said in a statement that this is the first FDA-cleared, single-biomarker blood test supporting both “rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings.” “For decades, clinicians have faced significant challenges in accurately diagnosing Alzheimer's disease in its early stages,” said Jared R. Brosch, M.D., a neurologist at Indiana University Health, in a release.

“While PET imaging and cerebrospinal fluid biomarkers can confirm amyloid pathology in patients with cognitive impairment," he added, "these approaches may be costly, invasive and not readily accessible for many patients.” Brosch continued: “Advances in blood-based biomarkers have the potential to transform the diagnostic pathway by expanding access to evaluation for Alzheimer's across a variety of care settings.” Both companies also saw a European approval for this test back in May. This is the second Alzheimer’s test to come from Roche and Lilly: Last July, the two pharmas received European approval for their first blood test designed to help rule out Alzheimer’s disease. That test, also called Elecsys, detects phosphorylated tau-181 protein in the blood.

It was also approved by the FDA in February. Roche Eli Lilly Alzheimer's disease Diagnostics MedTech