Quest Diagnostics Unveils FDA-Cleared Blood Test for Alzheimer's Disease

In a significant advancement for Alzheimer’s disease diagnostics, Quest Diagnostics Inc. (NYSE: DGX) has announced its plans to offer the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test developed by Fujirebio. This test has recently received clearance from the U.S. Food and Drug Administration (FDA), making it the first blood-based IVD test to be approved for identifying patients with amyloid pathology associated with Alzheimer’s disease.

Quest Diagnostics plans to roll out this groundbreaking test to physicians and biopharmaceutical collaborators later this summer. The Fujirebio test is specifically designed for adult patients aged 50 years and older, who present symptoms of cognitive decline at specialized care settings. This initiative marks a pivotal moment in the realm of Alzheimer’s diagnostics, potentially revolutionizing the way cognitive decline is assessed.

Quest Diagnostics has a comprehensive suite of advanced lab-developed blood tests under its AD-Detect™ portfolio, which are regulated under the Clinical Laboratory Improvement Amendments (CLIA). The addition of the Fujirebio test enhances this portfolio, providing an FDA-cleared option for clinicians in specialized care environments.

Kathleen Valentine, Vice President and General Manager of Neurology at Quest, remarked, “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.”

In a clinical study involving 499 patients that closely reflects U.S. demographics, the FDA-cleared Fujirebio test demonstrated impressive efficacy metrics. The test achieved a positive predictive value (PPV) of 92% and a negative predictive value (NPV) of 97%. However, it also identified that 20% of patients remained uncertain regarding amyloid pathology, indicating a need for further testing.

As Michael Racke, MD, Medical Director of Neurology at Quest, emphasized, “As brain health and Alzheimer’s disease interventions continue to evolve, diagnosing patients earlier, when interventions can be most effective, is critical.” The introduction of this blood test could facilitate earlier diagnosis, allowing for timely interventions that may improve patient outcomes.

Traditional methods for diagnosing Alzheimer’s disease, such as amyloid PET imaging and cerebrospinal fluid (CSF) testing, are notably more invasive and costly. The Fujirebio test presents a less invasive alternative that can be conducted through a simple blood draw. With a physician’s order, patients can access testing across Quest’s extensive network of approximately 8,000 patient access points, including around 2,000 patient service centers and mobile phlebotomy services.

Currently, nearly 7 million Americans are living with Alzheimer’s disease, a number projected to escalate to 14 million by 2060. Furthermore, about 12-18% of adults over the age of sixty exhibit mild cognitive impairment, which can be an early sign of Alzheimer’s. A significant 77% of physicians believe that new therapies will enable Alzheimer’s to become a chronic, manageable condition. Additionally, 94% of physicians agree that blood tests, like the one offered by Quest, would be more cost-effective compared to invasive diagnostic methods.

Quest Diagnostics' commitment to advancing diagnostic innovation in the field of Alzheimer’s disease is evident with the introduction of the Fujirebio blood test. As the company prepares to showcase its full range of Alzheimer’s and neurological testing innovations at the upcoming Alzheimer’s Association International Conference (AAIC) in Toronto from July 27-31, the healthcare community eagerly anticipates the potential impacts on early diagnosis and treatment pathways for millions of individuals at risk of cognitive decline.

For more information about Quest Diagnostics and its offerings, visit www.QuestForTheCure.com.