Quest Diagnostics Launches New AD-Detect™ Blood Test to Aid in Confirming Alzheimer's Disease

Core Viewpoint - Quest Diagnostics has launched a new laboratory blood test, AD-Detect™ Abeta 42/40 and p-tau217 Evaluation, which can accurately assess Alzheimer's disease pathology with over 90% sensitivity and specificity, aimed at confirming amyloid brain pathology in patients with mild cognitive impairment or dementia [1][2]. Test Details - The AD-Detect test combines blood levels of amyloid beta (AB) 42/40 and p-tau217, producing an AD-Detect Likelihood Score™ through a proprietary algorithm validated with a cohort from the 1Florida Alzheimer's Disease Research Center [2]. - This test builds on previous AD-Detect tests that assessed individual biomarkers, now providing a more comprehensive evaluation of amyloid brain pathology [3]. Clinical Implications - The test demonstrates a positive predictive value (PPV) and negative predictive value (NPV) of 89% in a population with mild cognitive impairment, with improved predictive values when including ApoE genetic risk marker [6]. - The test's reliability is supported by a heterogeneous population with a low prevalence of beta amyloid PET positivity, indicating its effectiveness in real-world scenarios [6]. Market Position - Quest's AD-Detect suite offers a range of validated blood-based biomarkers, enhancing personalized testing options for providers [4]. - The new test aims to provide scalable, high-volume solutions for Alzheimer's evaluation, potentially reducing the need for more invasive and costly diagnostic methods like PET imaging and lumbar puncture [8]. Access and Availability - The test is available for physicians in the United States, except New York, with blood draws conducted through Quest's extensive network of approximately 8,000 patient access points [10][14]. - Quest Diagnostics serves a significant portion of the U.S. population, with nearly 55,000 employees dedicated to improving health outcomes through diagnostic insights [13]. Industry Context - Nearly 7 million Americans currently have Alzheimer's, a number projected to reach 14 million by 2060, highlighting the growing need for effective diagnostic solutions [11]. - A significant majority of physicians believe that new therapies will transform Alzheimer's into a manageable disease, and they favor blood tests as a more cost-effective alternative to traditional diagnostic methods [11].