ARUP Laboratories announced today that the Food and Drug Administration (FDA) has filed ARUP’s premarket approval application (PMA) for an AAV5 total antibody assay. The assay is intended as a companion diagnostic test for valoctocogene roxaparvovec, BioMarin’s investigational gene therapy treatment for severe hemophilia A.
BioMarin partnered with ARUP to develop this test. ARUP is a laboratory with 35 years of experience supporting hospitals, physicians, and patients with unparalleled quality and service including two prior FDA companion diagnostic approvals. ARUP’s experience in developing FDA-approved, single-source companion diagnostic tests is unique among reference laboratories.
ARUP’s AAV5 total antibody assay is a simple blood test that is intended to help identify patients most likely to respond to AAV5-based gene therapy. BioMarin implemented the test in multiple clinical studies evaluating valoctocogene roxaparvovec treatment of hemophilia A patients without antibodies to AAV5. If approved, ARUP’s AAV5 total antibody assay may be the first companion diagnostic test for any gene therapy product.
“We are delighted to have partnered with BioMarin on its hemophilia A gene therapy program,” said ARUP CEO Sherrie Perkins, MD, PhD. “Working with BioMarin on the simultaneous submission of the diagnostic and gene therapy applications aligns with our corporate commitment to providing outstanding patient care through cutting-edge diagnostic testing.”
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