The company will introduce a new Roche assay and a multi-biomarker laboratory-developed test designed to improve diagnostic accuracy.
Quest Diagnostics announced two developments for its portfolio of blood-based biomarker tests for Alzheimer disease, including the adoption of a newly cleared assay from Roche and the launch of a multi-biomarker laboratory-developed test.
The Food and Drug Administration (FDA) cleared the Roche Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, which is the first single-assay, single-biomarker test to support both rule-in and rule-out assessment of amyloid pathology using validated clinical cutoffs. Quest plans to introduce a laboratory test service based on the FDA-cleared assay to physicians and clinical trials collaborators in the fourth quarter of 2026.
“Blood-based biomarker testing has rapidly set a new standard of care for guiding treatment and diagnosis decisions for Alzheimer’s disease,” says Michael K Racke, MD, a board-certified neurologist and senior medical director, neurology, Quest Diagnostics, in a release. “As a long-time collaborator with Roche, we look forward to adding the Elecsys pTau217 to our AD-Detect portfolio, which will give physicians across the US ready access to this important biomarker test.”
Quest also announced the launch of a new multi-biomarker laboratory-developed test, the AD-Detect ABeta 42/40, p-tau217, and ApoE Evaluation, at the end of August 2026. The test provides a score predicting the likelihood of Alzheimer pathology based on results of pTau217 using a third-party in vitro diagnostic as well as results of amyloid beta 42/40 and the APOE isoform, a genetic risk marker, using mass spectrometry.
Research published in Neurology Clinical Practice demonstrates that the new test aligns with Alzheimer Association guidelines. These guidelines state that blood-based tests achieving sensitivity and specificity of approximately 90% in specialist settings may be used to confirm a diagnosis and aid clinical decisions without additional testing. The research also found that the new test achieved an indeterminate rate of 10%, compared to the 15% to 20% rate recommended by the Global CEO Initiative on Alzheimer Disease for a typical clinical population.
“Quest’s extensive research demonstrates that blood-based biomarker testing that includes multiple biomarkers may be more sensitive and specific for Alzheimer’s pathology and produces a lower rate of indeterminates compared to the same tests performed individually,” says Amanda Backner, executive director and general manager, neurology, Quest Diagnostics, in a release.
While PET-CT scans and cerebrospinal fluid testing are established methods for aiding diagnosis, they can be costly, invasive, and difficult to access outside specialty centers. In a study published in the Journal of Prevention of Alzheimer’s Disease, researchers determined that blood-based biomarker testing was a more efficient and cost-effective method of assessing Alzheimer pathology in patients with cognitive decline than amyloid PET scans.
ID 64263579 © Ken Wolter | Dreamstime.com
