Quest Diagnostics Partners with Fujirebio to Offer Alzheimer's Diagnostic Test

Quest Diagnostics plans to introduce a new laboratory test using Fujirebio's Lumipulse diagnostic technology to identify patients with amyloid pathology linked to Alzheimer's disease. The company aims to provide this test to healthcare professionals to aid in diagnosing and managing Alzheimer's.

Quest Diagnostics (NYSE: DGX) has announced plans to introduce a new laboratory test using Fujirebio's Lumipulse diagnostic technology to identify patients with amyloid pathology linked to Alzheimer's disease. The company aims to provide this test to healthcare professionals to aid in diagnosing and managing Alzheimer's.

The new test, based on the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test from Fujirebio, 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. Quest Diagnostics plans to make the test available to physicians and biopharmaceutical collaborators later this summer.

The test 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. In a clinical study population of 499 patients, which closely mirrors US demographics, the FDA-cleared test demonstrated a positive predictive value (PPV) of 92% and a negative predictive value (NPV) of 97%, with 20% of patients requiring further testing.

Quest Diagnostics, which provides a suite of advanced lab-developed blood tests regulated under CLIA for assessing patients with cognitive impairment for Alzheimer's disease through its AD-Detect™ portfolio, will extend this portfolio to include the Fujirebio test offering. This addition will provide healthcare professionals with another powerful option for assessing patients for Alzheimer's disease.

Quest Diagnostics 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.

References:
[1] https://www.prnewswire.com/news-releases/quest-diagnostics-to-offer-fda-cleared-fujirebio-blood-test-for-alzheimers-disease-302500634.html
[2] https://www.patientcareonline.com/view/quest-will-offer-fda-cleared-fujirebio-blood-test-to-detect-alzheimer-disease
[3] https://www.stocktitan.net/news/DGX/quest-diagnostics-to-offer-fda-cleared-fujirebio-blood-test-for-mbvoeb77fy1a.html