Monday, April 29, 2024
Labcorp a leading provider of innovative laboratory services worldwide, has received FDA approval for its nAbCyte™ Anti-AAVRh74var HB-FE Assay. This assay serves as a companion diagnostic (CDx) for identifying patients eligible for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's newly FDA-approved gene therapy for hemophilia B.
The nAbCyte assay is a crucial component of Pfizer's program aimed at directing recombinant adeno-associated virus (rAAV)-based gene therapies to the appropriate patient population. Prior to administering BEQVEZ, patients must undergo testing for preexisting anti-AAVRh74var antibodies. Labcorp's nAbCyte assay accurately detects preexisting neutralizing antibodies (nAbs), which could affect the safety and efficacy of this one-time treatment.
Labcorp's President of Early Development Research Laboratories and Chief Medical and Scientific Officer, expressed Labcorp's dedication to advancing cell and gene therapy and providing clinicians with tools to make informed treatment decisions.
The FDA approval of the nAbCyte assay marks a significant advancement in companion diagnostics, promising to revolutionize the therapeutic landscape for patients with rare, inherited conditions.
Hemophilia B affects approximately 6,000 individuals in the United States, causing abnormal blood clotting due to a deficiency in Factor IX (FIX). Up to 60% of the American population may have preexisting anti-AAV antibodies, potentially interfering with rAAV gene delivery, underscoring the necessity of nAbCyte CDx testing before BEQVEZ treatment.
Highlighted the importance of the nAbCyte companion diagnostic in guiding physicians and patients considering BEQVEZ as a treatment option for hemophilia B.
The qualitative reporting of nAbCyte test results as negative (not detected) or positive (detected) enables clinicians to determine eligibility for BEQVEZ therapy.
The FDA approval of the nAbCyte Anti-AAVRh74var HB-FE CDx reinforces Labcorp's comprehensive cell and gene therapy solutions, encompassing pre-clinical toxicology, biomarker and CDx development, and post-commercialization capabilities.
Labcorp a leading provider of innovative laboratory services worldwide, has received FDA approval for its nAbCyte™ Anti-AAVRh74var HB-FE Assay. This assay serves as a companion diagnostic (CDx) for identifying patients eligible for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's newly FDA-approved gene therapy for hemophilia B.
The nAbCyte assay is a crucial component of Pfizer's program aimed at directing recombinant adeno-associated virus (rAAV)-based gene therapies to the appropriate patient population. Prior to administering BEQVEZ, patients must undergo testing for preexisting anti-AAVRh74var antibodies. Labcorp's nAbCyte assay accurately detects preexisting neutralizing antibodies (nAbs), which could affect the safety and efficacy of this one-time treatment.
Labcorp's President of Early Development Research Laboratories and Chief Medical and Scientific Officer, expressed Labcorp's dedication to advancing cell and gene therapy and providing clinicians with tools to make informed treatment decisions.
The FDA approval of the nAbCyte assay marks a significant advancement in companion diagnostics, promising to revolutionize the therapeutic landscape for patients with rare, inherited conditions.
Hemophilia B affects approximately 6,000 individuals in the United States, causing abnormal blood clotting due to a deficiency in Factor IX (FIX). Up to 60% of the American population may have preexisting anti-AAV antibodies, potentially interfering with rAAV gene delivery, underscoring the necessity of nAbCyte CDx testing before BEQVEZ treatment.
Highlighted the importance of the nAbCyte companion diagnostic in guiding physicians and patients considering BEQVEZ as a treatment option for hemophilia B.
The qualitative reporting of nAbCyte test results as negative (not detected) or positive (detected) enables clinicians to determine eligibility for BEQVEZ therapy.
The FDA approval of the nAbCyte Anti-AAVRh74var HB-FE CDx reinforces Labcorp's comprehensive cell and gene therapy solutions, encompassing pre-clinical toxicology, biomarker and CDx development, and post-commercialization capabilities.
Source: prnewswire.com
