Approved under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR), the test is intended for selecting adult patients for Roctavian, a new gene therapy for severe haemophilia A.
This test received the CE mark in August 2020 under the previous In Vitro Diagnostic Medical Devices Directive.
Obtaining stringent IVDR approval will ensure continued patient access to testing in the EU after May 2026, when all medical devices must have IVDR approval.
With this approval, individuals residing in the EU and other nations that adhere to EU regulations can have their samples tested at ARUP’s central laboratory located in Salt Lake City.
The approval from European regulators was granted using data from clinical trials where ARUP’s test was utilised to establish patient eligibility.
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ARUP Clinical Trials and PharmaDx vice-president Jay Patel said: “We are proud to be involved in this effort to support the needs of patients with severe haemophilia A.
“We’ve demonstrated by our ability to execute on these stringent regulatory requirements that we’re committed to patient safety and access to testing.”
In June of this year, AAV5 DetectCDx secured approval from the US Food and Drug Administration, marking it as the first companion diagnostic immunoassay for gene therapy to receive such approval.
Serving clients across the US, ARUP provides over 3,000 tests and test combinations, ranging from regular screening tests to esoteric molecular and genetic assays.