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Labcorp Launches pTau217 Blood Biomarker Test to Accelerate Path to Diagnosis of Alzheimer's Disease and Support Clinical Trials

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Labcorp (NYSE: LH) launches pTau217 test to aid in Alzheimer's disease diagnosis and monitoring, expanding its testing options. The company aims to improve patient care by providing innovative laboratory services in the field of Alzheimer's disease. The test complements Labcorp's existing biomarker testing portfolio, offering physicians and biopharmaceutical partners a valuable tool for clinical trials and research.
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Labcorp's launch of the pTau217 test represents a notable development in the field of Alzheimer's diagnostics. By providing a blood-based biomarker for the disease, the test has the potential to simplify the diagnostic process, which traditionally relies on more invasive methods such as cerebrospinal fluid analysis or imaging techniques. The availability of this test could lead to earlier detection and intervention, which is critical for a disease that lacks a cure and where management focuses on slowing progression.

From a research standpoint, pTau217 has shown promise in clinical studies as a reliable indicator of Alzheimer's pathology, particularly in conjunction with anti-amyloid therapy. This could facilitate more targeted and efficient clinical trials, potentially accelerating the development of therapeutic agents. Moreover, the test's inclusion in Labcorp's broader Alzheimer's testing portfolio, which includes the beta-amyloid 42/40 ratio and NfL, enhances the company's competitive edge in the diagnostics market. This comprehensive approach aligns with the ATN framework (Amyloid, Tau, Neurodegeneration) used by researchers to categorize Alzheimer's biomarkers, signaling Labcorp's adherence to current scientific standards.

The introduction of the pTau217 test by Labcorp could have a substantial impact on the healthcare industry, particularly in the diagnostics sub-sector. Alzheimer's disease is associated with high healthcare costs and the ability to accurately diagnose and monitor the disease could lead to more efficient allocation of healthcare resources. The test's immediate availability for clinical trials and research also indicates Labcorp's strategic positioning to capitalize on partnerships with biopharmaceutical companies, which are actively seeking biomarkers to improve the efficiency of drug development.

Considering the projected increase in Alzheimer's prevalence, the demand for such diagnostic tools is expected to grow, potentially leading to increased revenue streams for Labcorp. However, the test's adoption rate will depend on factors such as insurance coverage, cost-effectiveness and integration into clinical practice guidelines. The long-term impact on Labcorp's financial health will hinge on the test's clinical utility and market acceptance. It is important to monitor subsequent earnings reports and market analysis for indications of the test's performance and its contribution to Labcorp's overall business strategy.

The announcement by Labcorp introduces a new product in a market with a growing patient population and a clear unmet medical need. Investors might view this as a positive development for Labcorp's revenue diversification and potential growth. The ability to offer a novel test like pTau217 could enhance Labcorp's reputation as an innovator in diagnostic testing, potentially increasing its market share in the Alzheimer's testing space.

One must consider the impact this could have on Labcorp's stock performance. If the test gains traction within the medical community, it could drive up the company's stock due to anticipated future earnings growth. Conversely, any setbacks in the test's efficacy, acceptance, or insurance coverage could negatively affect investor sentiment. Close attention to the adoption rate of the pTau217 test and its reception by the medical community, as well as any strategic partnerships with pharmaceutical companies, will be key in assessing its financial implications for Labcorp.

Addition of pTau217 test further expands the company's leadership in testing options for Alzheimer's disease to improve patient care 

BURLINGTON, N.C., March 20, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the launch and immediate availability of its test to identify the presence or absence of phosphorylated tau 217 (pTau217), a pivotal blood biomarker designed to aid in the diagnosis of Alzheimer's disease and the subsequent monitoring of patients undergoing treatment with new Alzheimer's disease therapies. Labcorp's pTau217 test can be ordered by physicians and used in clinical trials and research by global biopharmaceutical partners.

Alzheimer's disease, the most prevalent form of dementia, poses a significant health challenge globally. An estimated 6.7 million Americans are currently living with Alzheimer's disease, a figure projected to more than double to 13.8 million individuals by 2060. The pTau217 marker has been used in Alzheimer's drug trials to monitor patients on anti-amyloid therapy.

Labcorp's introduction of pTau217 as a standalone test marks a significant advancement in the company's Alzheimer's testing portfolio, complementing its existing array of blood-based biomarker testing, including:

  • Beta amyloid 42/40 ratio, which provides an indication of amyloid pathology for Alzheimer's disease and is available nationwide for clinicians and available in Europe as a CE-marked assay.
  • Neurofilament light chain (NfL), which provides an indication of disease severity by measuring current levels of neurodegeneration.
  • ATN Profile, which combines three blood biomarkers – beta amyloid 42/40, NfL and pTau181. The ATN Profile provides physicians with an accessible and interpretable blood test to assess pathologies associated with Alzheimer's disease and other neurodegenerative conditions, which can help accelerate the path to diagnosis and intervention.

"The introduction of pTau217 represents a significant milestone in our ongoing commitment to advancing testing capabilities across the spectrum of Alzheimer's disease," said Dr. Brian Caveney, Labcorp's Chief Medical and Scientific Officer. "By expanding our suite of blood-based biomarker tests, we are empowering clinicians and pharma with more tools for clinical trials and for the detection and monitoring of Alzheimer's to improve patient care."

For more information about the pTau217 biomarker and the use of Labcorp's new test in patient care, visit http://www.labcorp.com/alzheimers.

For biopharma laboratory services inquiries, please visit https://www.labcorp.com/neurology/neurodegenerative-diseases/pharmaceutical-partners.

About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in over 100 countries, worked on over 84% of the new drugs approved by the FDA in 2023 and performed more than 600 million tests for patients around the world. Learn more about us at www.labcorp.com.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-launches-ptau217-blood-biomarker-test-to-accelerate-path-to-diagnosis-of-alzheimers-disease-and-support-clinical-trials-302094433.html

SOURCE Labcorp

Labcorp's pTau217 test is a pivotal blood biomarker designed to aid in the diagnosis of Alzheimer's disease and the monitoring of patients undergoing treatment with new Alzheimer's disease therapies.

The pTau217 test can be ordered by physicians for patient diagnosis and monitoring, as well as used in clinical trials and research by global biopharmaceutical partners.

Labcorp offers a range of blood-based biomarker tests including Beta amyloid 42/40 ratio, Neurofilament light chain (NfL), and the ATN Profile combining beta amyloid 42/40, NfL, and pTau181.

The introduction of pTau217 as a standalone test complements Labcorp's existing array of blood-based biomarker testing, providing clinicians and pharma with more tools for clinical trials and patient care.

Dr. Brian Caveney is Labcorp's Chief Medical and Scientific Officer.
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recognized for our innovation, quality, and customer convenience, labcorp delivers timely, accurate results for improved patient care. with scientific expertise in esoteric testing, genomics, and clinical and anatomic pathology, labcorp performs more than one million tests on approximately 400,000 samples each day. labcorp is a pioneer in applying advances in medicine and science to laboratory testing, with more than 35 years of experience in serving physicians and their patients. labcorp operates a sophisticated laboratory network, with corporate headquarters in burlington, nc, and more than 34,000 employees worldwide. our more than 220,000 clients include physician offices, hospitals, managed care organizations, and biotechnology and pharmaceutical companies. laboratory corporation of america holdings is listed on the new york stock exchange (nyse) under ticker symbol lh.