ARUP Laboratories has received approval from the US Food and Drug Administration (FDA) for its AAV5 DetectCDx as a companion diagnostic (CDx) to select eligible adult patients for treatment with Roctavian (valoctocogene roxaparvovec-rvox).
AAV5 DetectCDx is a qualitative in vitro diagnostic test for the detection of antibodies in human plasma collected in 3.2% sodium citrate that binds to the adeno-associated virus serotype 5 (AAV5).
Developed by ARUP in partnership with BioMarin Pharmaceutical, the test is said to be the first CDx immunoassay for a gene therapy product to receive FDA clearance.
ARUP, a clinical and pathology services provider, will act as the sole laboratory testing provider in the US.
Developed by BioMarin, Roctavian is a new gene therapy that secured contemporaneous FDA approval to treat adults with severe haemophilia A without antibodies to AAV5 detected by an FDA-approved test.
ARUP said that the new gene therapy aims to lessen or remove the need for chronic prophylactic therapy by delivering a functional copy of the FVIII gene in a one-time infusion using AAV5 as a vector.
AAV5 DetectCDx is intended to detect the presence of preexisting anti-AAV5 antibodies that may prevent the treatment from working effectively. It was used in various clinical studies that showed ROCTAVIAN might help adult patients with severe haemophilia A.
Under the present FDA approval, only people without anti-AAV5 antibodies will be qualified to receive ROCTAVIAN, the pathology services provider said.
ARUP Laboratories PharmaDx and Clinical Trials executive director Jay Patel said: “By leveraging diagnostic testing, we can identify which patients are eligible to receive treatment.
“We are proud of our role in the advancement of this revolutionary type of treatment.”
The clinical and pathology services provider said that the latest in vitro diagnostic test is its third FDA-approved companion diagnostic test.
Furthermore, AAV5 DetectCDx received Conformité Européenne (CE) mark under the In Vitro Diagnostic Medical Devices Directive (IVDD) in August 2021 for use in Europe.
