By Danny Sullivan – Longevity.Technology –
Pharma and diagnostics giant Roche today revealed it has received clearance from the US FDA for its Elecsys pTau181 test, making it the only FDA-cleared blood-based biomarker test that can be used in primary care settings to help rule out Alzheimer’s-related amyloid pathology.
The Roche test measures levels of phosphorylated Tau (pTau181) protein in human plasma, a marker associated with Alzheimer’s pathology that includes amyloid plaques and tau aggregates. Developed in partnership with Eli Lilly, the test is designed to help clinicians identify patients in early stages of impairment who are unlikely to have Alzheimer’s-related changes, allowing them to focus further diagnostic resources on those more likely to have the disease.
While blood tests designed to confirm cases of Alzheimer’s tend to grab the headlines, the ability to rule out cases is viewed as key step towards streamlining the diagnostic pathway for the disease. The arrival of an effective rule-out blood-based test could enable clinicians to more easily differentiate Alzheimer’s from other causes of cognitive decline, reducing inappropriate prescribing and clarifying ambiguous cases, and may help identify appropriate candidates for anti-amyloid therapies or clinical trials. A simple blood test could also help reduce unnecessary use of more invasive and costly confirmatory procedures such as positron emission tomography scans or lumbar punctures.
