Invivoscribe has received In Vitro Diagnostic Regulation (IVDR) approval for its polymerase chain reaction (PCR)-based LeukoStrat CDx FLT3 Mutation Assay.
The test received approval from the BSI (Netherlands) and the European Medicines Agency as a Class C CDx assay.
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It has been developed for the detection of internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from acute myelogenous leukaemia patients.
Invivoscribe CEO and CSO Jeff Miller said: “By being one of the first CDx to be approved under IVDR, Invivoscribe has once again demonstrated our leadership position, our focus on regulatory compliance and our emphasis on the importance of international standardisation of molecular diagnostic assays.
“We believe that adherence to strict standards and lab practices is an example of where the value of vertical integration of our company becomes readily apparent.”
IVDR is a new classification system for in vitro diagnostic devices (IVDs) which considers the degree of risk associated with each device.
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By GlobalDataIt is divided into Class A (lowest risk), Class B, Class C, and Class D (highest risk).
Invivoscribe regulatory, quality and clinical affairs global director Jason Gerhold said that IVDR is a set of regulations introduced by the Europe Union for ensuring IVDs’ safety, traceability, quality and performance.
