Labcorp has announced the US Food and Drug Administration (FDA) approval of its nAbCyte Anti-AAVRh74var HB-FE assay for use with Pfizer’s newly approved gene therapy, Beqvez, to treat patients with haemophilia B.

The FDA has cleared the use of nAbCyte assay as a companion diagnostic (CDx) to determine eligible patients for treatment with Beqvez.

The nAbCyte cell-based neutralising antibody test is part of Pfizer’s programme to target recombinant adeno-associated virus (rAAV)-based gene therapies to the suitable patient population.

Under the programme, patients will have to be tested for preexisting anti-AAVRh74var antibodies before infusion with Beqvez.

Labcorp, which is a North Carolina-based laboratory services provider, said that the assay facilitates precise identification of preexisting neutralising antibodies (nAbs), crucial for assessing patient safety and efficacy of the one-time therapy.

Results from the nAbCyte test will be reported as either negative or positive and a negative test result will indicate that an individual is eligible for the gene therapy.

Labcorp chief medical and scientific officer and early development research laboratories president Brian Caveney said: “At Labcorp, we are committed to advancing cell and gene therapy and driving innovation that assists clinicians in making well-informed treatment decisions.

“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.”

The FDA approval of nAbCyte Anti-AAVRh74var HB-FE CDx expands Labcorp’s portfolio of cell and gene therapy solutions. The portfolio also includes specialised pre-clinical toxicology, biomarker and CDx development, and capabilities in post-commercialisation.

Pfizer US speciality care medical affairs head Sonal Bhatia said: “The approval of the nAbCyte companion diagnostic represents a first for a gene therapy that treats eligible patients with haemophilia B, helping to bring clarity to physicians and patients who are considering Beqvez as a treatment option.

“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.”