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