“Today we are pleased to announce that Invivoscribe’s LeukoStrat^® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the stringent new IVDR (Regulation (EU) 2017/746) requirements. Invivoscribe is one of the first companies in the world to gain an IVDR approval of a CDx assay. IVDR is a set of regulations that came into effect on May 26, 2022 that were put in place by the Europe Union (EU) to ensure the safety, traceability, quality and performance of in-vitro diagnostic medical devices (IVDs),” says Jason Gerhold, Global Director of Regulatory, Quality, and Clinical Affairs at Invivoscribe.

The IVDR applies to all existing and new IVDs placed on the market in the EU, including those that are imported from outside the EU. The IVDR is a new classification system for IVDs, based on the level of risk associated with the device. The classification system is divided into four classes, Class A (lowest risk), Class B, Class C, and Class D (highest risk). The classification of an IVD will determine the level of scrutiny it will receive during the conformity assessment process. The IVDR depends on notified bodies that are authorized by the EU to assess and certify IVDs. Notified bodies are independent organizations that are accredited by the EU to perform conformity assessments and issue CE certificates.

Manufacturers of IVDs are required to demonstrate compliance with the IVDR by implementing a quality management system and by providing technical documentation to support their claims of conformity. They will also be required to appoint an individual responsible for regulatory compliance and to maintain vigilance and post-market surveillance systems. Manufacturers will also have to provide a summary of safety and clinical performance (SSCP) for their devices which should be available to the public. Overall, the IVDR aims to increase the safety, traceability, quality and performance of IVDs, and to provide greater assurance to patients and healthcare professionals that the IVDs they use are reliable and accurate.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from patients diagnosed with acute myelogenous leukemia (AML). FLT3 somatic variants are among the most common driver mutations as is one of the strongest predictors of overall survival in acute myeloid leukemia (AML)¹, the deadliest form of leukemia. Each year in the U.S. AML is diagnosed in about 20,000, and statistics indicate that new AML patients with FLT3 mutations have only a 30.5% five-year relative survival rate².

“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 standardization 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,” said Jeff Miller, CEO and CSO of Invivoscribe. “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.”

References:
1. Daver N et al. Leukemia (2019) 33:299-312.
2. https://seer.cancer.gov/statfacts/html/amyl.html