Quest Diagnostics to Offer FDA-Cleared Roche pTau217 Blood Test to Assess Alzheimer's Disease Pathology
Rhea-AI Summary
Quest Diagnostics (NYSE: DGX) announced two expansions to its Quest AD-Detect® blood-based biomarker portfolio for assessing Alzheimer's disease in symptomatic patients. Quest plans to offer an AD-Detect-branded laboratory test based on Roche's newly FDA-cleared Elecsys® pTau217 assay nationwide in the fourth quarter, and to integrate this test into future AD-Detect panels in 2027.
Separately, Quest will launch at month-end a new multi-biomarker AD-Detect® lab-developed test combining ABeta 42/40, p-tau217 and ApoE evaluation. According to Quest, published research shows this test aligns with Alzheimer Association guideline thresholds and achieved a 10% indeterminate rate, below the 15–20% rate recommended by the Global CEO Initiative on Alzheimer's Disease.
Positive
- FDA-cleared pTau217 assay added via AD-Detect-branded lab test in Q4 nationwide
- New multi-biomarker AD-Detect panel (ABeta 42/40, p-tau217, ApoE) launching at month-end
- Indeterminate results only 10% vs CEOi recommended 15–20% in research cited by Quest
- Alignment with Alzheimer Association guidelines on ~90% sensitivity and specificity in intended specialist settings
- Broad U.S. access through about 2,000 Quest patient service centers plus in-office and mobile phlebotomy
- Study showed blood tests more efficient and cost-effective for Alzheimer's pathology assessment than amyloid PET scans
Negative
- None.
News Explained
For the announced portfolio, Quest says patients with a physician’s order can obtain any AD-Detect blood test through approximately 2,000 U.S. patient service centers, as well as physician-office and mobile phlebotomy services.
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Test to join the company's expansive portfolio of Quest AD-Detect® blood tests for assessing symptomatic patients
Quest also launching a new multi-biomarker AD-Detect® lab-developed blood test with low
Adding the FDA-cleared Elecsys pTau217 test to the AD-Detect™ portfolio
Earlier today, Roche announced that the
"Blood-based biomarker testing has rapidly set a new standard of care for guiding treatment and diagnosis decisions for Alzheimer's disease," said Michael K. Racke, MD, a board-certified neurologist and senior medical director, neurology, Quest Diagnostics. "As one of the pioneers in this field, Quest is constantly looking to add new innovations, both our own and from our collaborators, to our extensive AD-Detect portfolio so that physicians and patients can make the most informed care decisions. 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
New AD-Detect multi-biomarker panel with
Separate from the FDA clearance of the Roche pTau217 test, Quest also announced today it will launch its newest AD-Detect test innovation, AD-Detect® ABeta 42/40, p-tau217, and ApoE Evaluation, lab-developed test for physicians and clinical trials collaborators nationwide at the end of this month. The test provides a score predicting the likelihood of Alzheimer's 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 Quest's highly sensitive mass spectrometry method.
Research published in Neurology® Clinical Practice, a publication of the American Academy of Neurology, demonstrates that the new test aligns with guidelines from the Alzheimer Association, which state that blood-based tests that achieve sensitivity and specificity of approximately
"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," said Amanda Backner, executive director and general manager, neurology, Quest Diagnostics.
With a physician's order, patients may conveniently provide a blood draw for testing for any AD-Detect test through Quest's patient service center network of approximately 2,000 locations in the
While positron emission tomography-computed tomography (PET-CT) scan and cerebrospinal fluid (CSF) testing are well established methods for aiding the diagnosis of Alzheimer's disease, may be costly, invasive and difficult to access outside specialty centers. In a study recently published in the Journal of Prevention of Alzheimer's Disease, Quest researchers determined that blood-based biomarker testing was a more efficient and cost-effective method of assessing Alzheimer's pathology in patients with cognitive decline than amyloid PET scans.
For more information on Quest AD-Detect, visit www.QuestForTheCure.com.
About Quest Diagnostics
Quest Diagnostics works across healthcare to create a healthier world, one life at a time. We connect people, from clinicians to consumers, with laboratory insights that illuminate a path to better health. With a focus on delivering smarter, simpler testing, we help reveal new avenues to identify and treat disease, empower healthy behaviors and improve healthcare management. Quest Diagnostics serves half the physicians and hospitals in the United States and one in three American adults each year, and our nearly 60,000 employees work together to deliver diagnostic insights that inspire actions to transform lives. www.QuestDiagnostics.com
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SOURCE Quest Diagnostics