Invivoscribe has announced that its LeukoStrat CDx FLT3 Mutation Assay has been cleared by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the new In Vitro Diagnostic Devices Regulation (IVDR) requirements of the European Union (EU).

The LeukoStrat CDx FLT3 Mutation Assay is said to be a Polymerase chain reaction (PCR)-based in vitro diagnostic test.

The US-based biotechnology company has designed the test to identify internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic Deoxyribonucleic acid (DNA).

The test intends to extract the DNA from individuals diagnosed with acute myelogenous leukaemia (AML).

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.

“With a highly talented global team, expertise in R&D, bioinformatics and AI, cGMP manufacturing, regulatory, quality, clinical affairs, sales, marketing, and performance of our clinical laboratories around the world, Invivoscribe is well positioned to serve the needs of healthcare providers, and global and regional pharma and biopharma partners.”

According to Jason Gerhold, global director of regulatory, quality, and clinical affairs at Invivoscribe, the biotechnology company is one of the first companies in the world to gain IVDR approval for a CDx assay.

The IVDR is a new classification system for IVDs. It is based on the level of risk linked with the device. The classification of an IVD will give the level of scrutiny it will get in the conformity assessment process.

The biotechnology company has successfully partnered with pharmaceutical firms interested in developing and commercialising companion diagnostics, providing regulatory and laboratory services expertise.

Invivoscribe provides distributable kits and clinical trial services via its globally located clinical lab subsidiaries (LabPMM).