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.
Diagnostics Firm Enzyre Nabs €1.4M Loan
Enzyre is developing a near-patient platform called Enzypad to measure biomarkers in body fluids. The first application will be the monitoring of hemophilia.
ARUP Labs Seek PMA for Hemophilia Gene Therapy CDx
ARUP partnered with BioMarin to develop the blood-based assay, which is intended to identify those patients most likely to respond to the drug firm's AAV5-based gene therapy.
Takeda, Enzyre Collaborate on At-Home Coagulation Test for Hemophilia
Enzyre said its platform technology, which requires a small volume of blood, is able to measure up to 12 reactions simultaneously with high sensitivity and specificity.