Quest Diagnostics to Offer FDA-Cleared Roche pTau217 Blood Test to Assess Alzheimer's Disease Pathology

Quest Diagnostics (NYSE: DGX) announced two new developments for its Quest AD-Detect® portfolio of blood-based biomarker tests for Alzheimer's disease, aiming to broaden access to quality blood tests for evaluating symptomatic patients. The company plans to introduce an AD-Detect-branded laboratory test service based on Roche's FDA-cleared Elecsys® Phospho-Tau (217P) Plasma (pTau217) blood test in the fourth quarter. This test is the first and only FDA-cleared single-assay, single-biomarker blood biomarker test that supports both rule-in and rule-out assessment of amyloid pathology. Quest also plans to incorporate the Roche test into future AD-Detect panels in 2027. Quest is also launching its newest AD-Detect test innovation, AD-Detect® ABeta 42/40, p-tau217, and ApoE Evaluation, a lab-developed test, at the end of this month. This new test provides a score predicting the likelihood of Alzheimer's pathology based on results of pTau217, amyloid beta 42/40, and the APOE isoform. Research indicates this new test achieved an indeterminate rate of 10%, lower than the 15%-20% rate recommended by the Global CEO Initiative on Alzheimer's Disease (CEOi) for a typical clinical population.