Quest Diagnostics to Offer FDA-Cleared Fujirebio Blood Test for Alzheimer's Disease

Rhea-AI Summary

Quest Diagnostics (NYSE: DGX) announced plans to offer the first FDA-cleared blood-based test for Alzheimer's disease, the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test from Fujirebio. The test will be available for clinical and research use starting summer 2025.

The FDA-cleared test demonstrated impressive clinical results with a 92% positive predictive value and 97% negative predictive value in a study of 499 patients. It's designed for adults aged 50+ showing signs of cognitive decline in specialized care settings. Quest will provide the test through its network of approximately 8,000 patient access points, including 2,000 patient service centers across the U.S.

This addition complements Quest's existing AD-Detect™ portfolio of blood tests for Alzheimer's assessment, offering a less invasive and more convenient alternative to traditional amyloid PET imaging and spinal fluid testing methods.

Positive

• First FDA-cleared blood-based test for Alzheimer's disease detection
• High accuracy with 92% positive predictive value and 97% negative predictive value
• Extensive accessibility through 8,000 patient access points nationwide
• Less invasive and more cost-effective than traditional testing methods
• Addresses a growing market with 7 million Americans having Alzheimer's

Negative

• 20% of patients show uncertain results requiring additional testing
• Limited to specialized care settings only
• Test restricted to patients aged 50 years and older

Test to be available for clinical and research use as soon as this summer, building on Quest's pioneering blood-based AD-Detect™ product line for assessing symptomatic patients

SECAUCUS, N.J., July 9, 2025 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced it plans to offer laboratory testing based on the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test from Fujirebio, a global leader in the field of high-quality IVD testing.

Quest plans to make the test available to physicians and biopharmaceutical collaborators later this summer. The test is the first blood-based IVD test cleared by the U.S. Food and Drug Administration (FDA) to aid in identifying patients with amyloid pathology associated with Alzheimer's disease. It is designed to aid the clinical assessment of Alzheimer's disease in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline.

Through its AD-Detect™ portfolio, Quest provides a suite of advanced lab-developed blood tests regulated under CLIA for assessing patients with cognitive impairment for Alzheimer's disease. The Fujirebio test offering extends this portfolio to include an FDA-cleared option for use in specialized care settings.

"Our goal is to advance access to quality and innovative blood-based tests for Alzheimer's disease. Adding the Fujirebio test to our existing blood-based tests provides the many physicians we serve with another powerful option for assessing patients for Alzheimer's disease," said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. "Blood-based testing can be less invasive and more convenient than traditional test methods. We are excited to leverage our expansive network of patient service centers to broaden access to the Fujirebio innovation to help more at-risk individuals gain access to the insights they need sooner."

In a clinical study population of 499 patients, which closely mirrors US demographics, and when applying a dual cut point, the FDA-cleared test demonstrated a positive predictive value (PPV) of 92% and a negative predictive value (NPV) of 97%, with 20% of patients uncertain to have amyloid pathology, thus requiring further testing.

Quest will showcase its complete line up of Alzheimer's and other neurological test innovations at this year's Alzheimer's Association International Conference (AAIC) in Toronto from July 27-31.

"As brain health and Alzheimer's disease interventions continue to evolve, diagnosing patients earlier, when interventions can be most effective, is critical," said Michael Racke, MD, a board-certified neurologist and Medical Director of Neurology, Quest Diagnostics. "We are constantly looking for ways to help physicians and patients make the most informed decisions, and this new addition to our test menu will aid that goal."

While amyloid PET imaging and cerebral spinal fluid testing are established methods for aiding the diagnosis of Alzheimer's disease, they are significantly more expensive, invasive and specialist-dependent than blood-based tests. With a physician's order, patients can conveniently provide a blood draw for testing for the Fujirebio test and any of the AD-Detect™ tests through Quest's network of patient sites. Quest maintains approximately 8,000 patient access points, including an extensive patient service center network of approximately 2,000 locations in the U.S., as well as phlebotomists in physician offices and mobile phlebotomy services. Specimens will be transported for testing to Quest's state-of-the-art laboratory in San Juan Capistrano, California.

Nearly 7 million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Approximately 12-18% of adults over the age of sixty are living with mild cognitive impairment, a potential sign of AD. Seventy-seven percent of physicians say new therapies will transform Alzheimer's into a chronic, manageable disease, and 94% of physicians say blood tests would be more cost effective for the healthcare system compared to more invasive methods of detection (e.g., lumbar puncture, imaging studies) according to a special report from Quest.

Quest is committed to developing and offering innovative advanced diagnostics to aid in evaluating Alzheimer's disease and other brain diseases. For more information, visit www.QuestForTheCure.com.

About Quest Diagnostics
Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com.

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SOURCE Quest Diagnostics

FAQ

What is the accuracy of Quest Diagnostics' new Alzheimer's blood test (DGX)?

The FDA-cleared test showed 92% positive predictive value and 97% negative predictive value in a clinical study of 499 patients.

When will Quest Diagnostics (DGX) launch the new Alzheimer's blood test?

Quest plans to make the Fujirebio blood test available to physicians and biopharmaceutical collaborators later in summer 2025.

Who can get the new Quest Diagnostics Alzheimer's blood test?

The test is designed for adults aged 50 years and older who show signs of cognitive decline and are being evaluated in specialized care settings.

How many locations offer Quest Diagnostics' new Alzheimer's test?

The test will be available through Quest's network of approximately 8,000 patient access points, including 2,000 patient service centers across the U.S.

What advantages does Quest's new blood test offer over traditional Alzheimer's tests?

The blood test is less invasive, more convenient, and more cost-effective than traditional amyloid PET imaging and cerebral spinal fluid testing methods.