Summary:
Quest Diagnostics will offer the FDA-cleared Fujirebio Lumipulse G pTau 217/β-Amyloid 1-42 blood test this summer to enhance early detection of Alzheimer’s disease through its AD-Detect portfolio.

Takeaways:

  • First FDA-cleared blood-based test for Alzheimer’s: The Fujirebio test aids in identifying amyloid pathology in adults with cognitive symptoms and offers a less invasive alternative to traditional diagnostic methods.
  • Quest expands access via large national network: The test will be available through Quest’s 8,000 patient access points, helping physicians diagnose Alzheimer’s more easily and cost-effectively.
  • Strong clinical validation: In a diverse U.S. population study, the test showed high predictive values (PPV 92%, NPV 97%), supporting its reliability in assessing Alzheimer’s risk.

Quest Diagnostics, a provider of diagnostic information services, including advanced diagnostics for brain health, has announced it plans to offer laboratory testing based on the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) blood test from Fujirebio, a global leader in the field of high-quality IVD testing.

Quest plans to make the blood 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.

AD-Detect Portfolio Is Designed to Diagnose Alzheimer’s

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,” says Kathleen Valentine, vice president and general manager, Neurology for 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.”

Alzheimer’s Blood Test Showed High Effectiveness in Clinical Study

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,” says Michael Racke, MD, a board-certified neurologist and medical director of Neurology for 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.

US Alzheimer’s Cases Projected to Reach 14 Million by 2060

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.

Featured Image: Felipe Caparros Cruz | Dreamstime.com