FDA clears Roche’s blood-based test for Alzheimer’s assessment

The blood-based biomarker test was developed in partnership with Eli Lilly and Company.

The US Food and Drug Administration (FDA) has granted clearance for Roche’s Elecsys pTau181 test, a blood-based biomarker test for the preliminary evaluation of Alzheimer’s disease.

This test also aids in the assessment of other cognitive decline causes within the primary care environment.

Designed for individuals who are 55 years and above experiencing cognitive decline symptoms, the minimally invasive test gauges the phosphorylated Tau (pTau) 181 protein present in the plasma of humans.

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