Labcorp Receives FDA Approval for First Companion Diagnostic for Use with Pfizer's Newly Approved Gene Therapy to Treat Patients with Hemophilia B

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Labcorp has received FDA approval for the first companion diagnostic for use with Pfizer's newly approved gene therapy to treat patients with Hemophilia B. The nAbCyte Anti-AAVRh74var HB-FE Assay will determine patient eligibility for treatment with BEQVEZ, Pfizer's gene therapy. Approximately 6,000 individuals in the US have Hemophilia B, and up to 60% of the population may have preexisting anti-AAV antibodies. Labcorp's assay will help identify patients suitable for gene therapy, marking a significant advancement in precision medicine and gene therapy.

Positive

• Labcorp's nAbCyte Assay approval enhances their leadership in precision medicine and gene therapy solutions.

• Labcorp's CDx will help determine eligibility for Pfizer's BEQVEZ gene therapy for Hemophilia B patients.

• About 6,000 people in the US have Hemophilia B, with many having preexisting anti-AAV antibodies.

Negative

• The presence of preexisting anti-AAV antibodies in 60% of the population could impact the efficacy of gene therapy.

Medical Research Analyst

The FDA's approval of Labcorp's nAbCyte assay signifies a noteworthy advancement in precision medicine, specifically in the realm of hemophilia B treatment. The assay is a pivotal step in ensuring that patients with preexisting anti-AAV antibodies are identified, which is critical as roughly 60% of the U.S. population may have these antibodies that can hinder the success of gene therapy. The nAbCyte test's ability to discern patient eligibility for Pfizer's BEQVEZ is a major milestone in personalized healthcare, allowing for a more targeted treatment approach which could lead to better clinical outcomes.

Biotech Market Analyst

From an investment perspective, Labcorp's introduction of the first FDA-approved companion diagnostic for hemophilia B gene therapy could potentially strengthen its market position in precision medicine. Given the high prevalence of anti-AAV antibodies in the general population, the nAbCyte assay addresses a significant unmet need and could see widespread adoption. This is likely to positively affect Labcorp's financials in the form of increased revenue from the testing services. Moreover, partnerships with treatment providers like Pfizer could lead to further strategic opportunities, cementing Labcorp's role in the cell and gene therapy diagnostics segment.

Pharmaceutical Industry Consultant

The strategic implications for stakeholders in the pharmaceutical and diagnostic sectors are multifaceted. Labcorp's innovation reinforces the importance of companion diagnostics in the era of personalized medicine, potentially setting a new standard for the industry. Biopharmaceutical companies might now consider the integration of similar diagnostics in their drug development programs. For investors, the key takeaway is the expanding value proposition of companies like Labcorp that are able to bridge the gap between advanced therapies and patient eligibility through cutting-edge diagnostics.

Assay expands company's leadership in precision medicine and cell and gene therapy

BURLINGTON, N.C., April 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA-approved hemophilia B gene therapy.

The nAbCyte cell-based neutralizing antibody assay is a component of Pfizer's program to target recombinant adeno-associated virus (rAAV)-based gene therapies to the appropriate patient population. Before infusion with BEQVEZ, patients will require testing for preexisting anti-AAVRh74var antibodies. Labcorp's nAbCyte cell-based neutralizing antibody assay will allow for the accurate detection of preexisting neutralizing antibodies (nAbs), which could impact patient safety and/or efficacy of the one-time treatment.

"At Labcorp, we are committed to advancing cell and gene therapy and driving innovation that assists clinicians in making well-informed treatment decisions," said Dr. Brian Caveney, Labcorp's President, Early Development Research Laboratories and Chief Medical and Scientific Officer. "Labcorp is proud to offer the first cell-based, companion diagnostic to receive FDA approval, which represents a pioneering breakthrough in the field of companion diagnostics and will help transform the therapeutic landscape and the lives of patients living with rare, genetically inherited conditions."

An estimated 6,000 people in the United States are living with hemophilia B, which is a rare inherited bleeding disorder that prevents normal blood clotting due to a deficiency in Factor IX (FIX), which causes those with the disease to bleed more frequently and longer than others. It is estimated that as many as 60% of the American population have preexisting anti-AAV antibodies, which could interfere with rAAV gene delivery, demonstrating the essential need for nAbCyte CDx testing prior to treatment with BEQVEZ.

"The approval of the nAbCyte companion diagnostic represents a first for a gene therapy that treats eligible patients with hemophilia B, helping to bring clarity to physicians and patients who are considering BEQVEZ as a treatment option," said Dr. Sonal Bhatia, M.D., Head of U.S. Specialty Care Medical Affairs, Pfizer. "We believe this companion diagnostic is an important tool for evaluating patients who may be suitable for gene therapy as the treatment paradigm advances with the introduction of gene therapies like BEQVEZ."

The results from the nAbCyte test will be reported qualitatively as negative (not detected) or positive (detected). A negative test result indicates that an individual with moderate to severe hemophilia B can be considered for BEQVEZ therapy.

The FDA approval of nAbCyte Anti-AAVRh74var HB-FE CDx builds on Labcorp's comprehensive cell and gene therapy solutions, including specialized pre-clinical toxicology, biomarker and CDx development, and post-commercialization capabilities.

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 approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA, and performed more than 600 million tests for patients around the world. Learn more about us at www.labcorp.com.

 

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SOURCE Labcorp

FAQ

What is Labcorp's FDA approval related to?

Labcorp received FDA approval for the first companion diagnostic for use with Pfizer's gene therapy to treat Hemophilia B.

How many individuals in the US have Hemophilia B?

Approximately 6,000 people in the US are living with Hemophilia B.

Why is Labcorp's nAbCyte Assay important?

Labcorp's nAbCyte Assay helps identify patients suitable for gene therapy by detecting preexisting neutralizing antibodies.

What percentage of the US population may have preexisting anti-AAV antibodies?

Up to 60% of the American population may have preexisting anti-AAV antibodies.

How will the nAbCyte test results be reported?

The nAbCyte test results will be reported as negative (not detected) or positive (detected), indicating suitability for BEQVEZ therapy.