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Labcorp to Launch FDA-Cleared Alzheimer's Blood Test

In a groundbreaking move in the Alzheimer’s diagnostic landscape, Labcorp (NYSE: LH), a leader in comprehensive laboratory services, has announced plans to introduce the Elecsys pTau181 blood test. This test stands out as the first of its kind to be cleared by the U.S. Food and Drug Administration (FDA), enabling its use in primary care settings. Scheduled for nationwide availability by early 2026, the test aims to transform the initial assessment process for Alzheimer’s disease and related cognitive decline.

An alarming statistic reveals that approximately 7.2 million Americans are currently affected by Alzheimer’s disease, a figure projected to swell almost double by 2050. Historically, the process of testing for Alzheimer’s-related biomarkers has remained complex, necessitating referrals to specialists and often more invasive procedures. The Elecsys pTau181 test seeks to streamline this process, targeting adults aged 55 and above who exhibit signs of cognitive decline. Clinicians will have the ability to order this test, which assists in ruling out Alzheimer's-related amyloid pathology, paving the way for patients who may need further evaluations.

Key Features and Impact of the Elecsys pTau181 Test

The Elecsys pTau181 test is designed to measure the levels of phosphorylated Tau (pTau) 181 protein in human plasma. This biomarker is critical to diagnosing Alzheimer's pathology, particularly concerning amyloid plaque formation and tau aggregate pathology. According to Roche, the manufacturer, the test has demonstrated a remarkable negative predictive value (NPV) of 97.9%, meaning it can accurately rule out Alzheimer’s pathology. In other words, a negative result on this test correlates with a negative result from a more invasive amyloid positron emission tomography (PET) scan, significantly reducing the likelihood that a patient’s cognitive issues stem from amyloid-related causes.

Furthermore, conducting the test involves a straightforward blood draw, which presents a more accessible and cost-effective alternative to traditional methods, such as cerebrospinal fluid (CSF) collection via lumbar puncture and PET scans. Once clinicians place an order, the blood sample can be obtained in a doctor's office or at one of Labcorp’s over 2,200 patient service centers across the nation.

Commitment to Alzheimer’s Testing

The introduction of the Elecsys pTau181 test underscores Labcorp's dedication to improving access to blood-based biomarkers for Alzheimer’s disease testing. Since March 2023, Labcorp has already been providing a laboratory-developed test (LDT) version of pTau181. Additionally, as of October 2023, this test became part of Labcorp's ATN Profile—an integrated panel focusing on three key biomarkers relevant to Alzheimer’s disease assessment.

Recently, the company also launched the FDA-cleared Lumipulse® pTau-217/Beta Amyloid 42 Ratio test, which further assists in the diagnosis of Alzheimer’s for specialty care settings. This series of launches reflects Labcorp's significant contributions to advancing the field of neurology and enhancing patient care.

For those interested in exploring the array of tests offered by Labcorp, additional information can be found on their official website.

About Labcorp

Labcorp prides itself on being a forerunner in the laboratory services sector, enabling healthcare professionals and researchers worldwide to make informed and confident decisions. With nearly 70,000 employees, Labcorp serves clients in approximately 100 countries and supports over 75% of new drugs and therapeutic products approved annually by the FDA. Additionally, the company conducts more than 700 million tests globally each year, underlining its pivotal role in advancing health through reliable and innovative diagnostic solutions.

For more details, visit Labcorp.