Roche announced today that the US Food and Drug Administration (FDA) has cleared the Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, providing clinicians across primary and specialty care with a single blood-based option to aid in identifying amyloid pathology associated with Alzheimer’s disease in individuals 55 years and older with signs, symptoms or complaints of cognitive decline.

Developed in collaboration with Eli Lilly and Company, Elecsys pTau217 is the first and only FDA-cleared, single-biomarker blood test that supports both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings.

The assay provides positive, intermediate and negative result categories to support assessment of the likelihood of amyloid pathology. Results are interpreted in conjunction with clinical information and other relevant findings as part of the Alzheimer’s disease diagnostic pathway. 

Healthcare providers across primary and specialty care now have access to the first and only FDA-cleared, single-biomarker blood test designed to support both rule-in and rule-out assessment of amyloid pathology. The test is designed for use across Roche’s more than 4,500 cobas laboratory instruments in the US, enabling broad access through existing laboratory infrastructure.

An estimated 75 percent of people living with dementia remain undiagnosed, and those who are diagnosed often experience years of uncertainty after symptoms first appear. Traditional approaches used to assess amyloid pathology, including Positron Emission Tomography (PET) imaging and cerebrospinal fluid (CSF) testing, may be costly, invasive and difficult to access outside specialty centers.

Carole Ho, MD, Executive Vice President (EVP) and President, Lilly Neuroscience, said, “For millions of families navigating the uncertainty of Alzheimer’s disease, a timely diagnosis is the first and most critical step toward meaningful care. Lilly’s collaboration with Roche on Elecsys pTau217 was driven by a shared commitment to bringing one blood test into both primary care, where most patients with cognitive complaints are first seen, and specialty care, helping close the gap between symptoms and answers.”

The Elecsys pTau217 blood test helps address these barriers by providing a minimally invasive blood-based option that can be incorporated into existing clinical and laboratory workflows. The test may help clinicians assess the likelihood of amyloid pathology earlier in the disease and diagnostic pathway and identify patients who should be considered for additional evaluation or specialist referral.

Jared R Brosch, MD, Neurologist, Indiana University Health, said, "For decades, clinicians have faced significant challenges in accurately diagnosing Alzheimer's disease in its early stages. While PET imaging and cerebrospinal fluid biomarkers can confirm amyloid pathology in patients with cognitive impairment, these approaches may be costly, invasive and not readily accessible for many patients. 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. As these tools become available, clinicians may be able to evaluate more patients earlier in the disease course, improving diagnostic confidence and helping patients and their families make more informed decisions at a critical time."