hemophilia
Labcorp Receives FDA Approval for CDx for Pfizer Hemophilia B Gene Therapy
The test is a cell-based neutralizing antibody assay that detects preexisting anti-AAVRh74var antibodies that could impact patient safety or the efficacy of treatment.
ARUP Laboratories Gains IVDR-CE Mark for Hemophilia Gene Therapy CDx
The Salt Lake City-based firm's test is used to identify hemophilia A patients eligible for treatment with BioMarin's Roctavian gene therapy.
ARUP Laboratories Gets FDA Approval for Hemophilia Gene Therapy CDx
The test determines whether a patient with hemophilia A have antibodies that could reduce the efficacy of BioMarin Pharmaceutical's Roctavian gene therapy.
Precision BioLogic Nabs FDA 510(k) Clearance for Factor IX Deficiency
The firm said its Cryocheck Chromogenic Factor IX test for managing hemophilia B is the only FDA-cleared chromogenic FIX assay on the US market.
DNA Medicine Institute Wins $1.5M NIH Grant to Develop Point-of-Care Factor VIII, Hemlibra Test
The test, which is licensed to rHealth, monitors FVIII levels in the blood of patients with hemophilia A patients, who lack the clotting protein.