Invivoscribe, Inc.
San Diego (ots/PRNewswire)
SAN DIEGO, May 11, 2023 /PRNewswire/– “We are pleased to announce today that the LeukoStrat® CDx flt3 -Invivoscribe’s mutation test has been approved by BSI (Netherlands) and EMA as a Class C CDx test that meets the stringent new IVDR requirements (Regulation (EU) 2017/746). Invivoscribe is one of the first companies in the world to receive IVDR clearance for a CDx test. “The IVDR is a set of regulations, effective May 26, 2022, put in place by the European Union (EU) to improve the safety, traceability, quality and performance of in vitro diagnostic medical devices (IVD). ensure,” said Jason Gerhold, Global Director of Regulatory, Quality and Clinical Affairs at Invivoscribe.
The IVDR applies to all existing and new IVDs placed on the EU market, including those imported from third countries. The IVDR is a new classification system for IVDs based on the 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 rating of an IVD determines the level of control it receives during the conformity assessment process. The IVDR relies on Notified Bodies authorized by the EU to assess and certify IVDs. Notified bodies are independent organizations accredited by the EU to carry out conformity assessments and issue CE certificates.
IVD manufacturers must demonstrate compliance with the IVDR by implementing a quality management system and providing technical documentation to support their claims of compliance. They will also be required to appoint a person responsible for compliance and maintain post-market surveillance systems. Manufacturers are also required to provide a Safety and Clinical Performance Summary (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 patients and healthcare professionals with greater assurance that the IVD they are using is reliable and accurate.
There LeukoStrat-CDx- flt3 mutation test is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 im flt3 gene in genomic DNA extracted from patients with acute myeloid leukemia (AML). flt3 -somatic variants are among the most common driver mutations and are one of the strongest predictors of overall survival in acute myeloid leukemia (AML)1, the deadliest form of leukemia. Approximately 20,000 patients are diagnosed with AML in the US each year, and statistics suggest that new AML patients are diagnosed with flt3 -mutations only have a 5-year relative survival rate of 30.5%2.
“As one of the first CDx approved under the IVDR, Invivoscribe has once again demonstrated our leadership, our focus on regulatory compliance and our focus on the importance of international standardization of molecular diagnostic testing. We believe adhering to rigorous standards and laboratory practices is an example where the value of vertically integrating our business is readily apparent,” noted Jeff Miller, CEO and CSO of Invivoscribe. “With a highly talented global team, R&D experience , bioinformatics and AI, cGMP manufacturing, regulatory, qualitative, 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 become.”
About Invivoscribe
Invivoscribe is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has been improving the quality of healthcare worldwide by providing high quality, standardized reagents, tests and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnering with global pharmaceutical companies interested in the development and commercialization of companion diagnostics and providing regulatory and laboratory services expertise. Invivoscribe offers both marketable kits and clinical trial services through its global subsidiaries (LabPMM) to clinical laboratories, making it an ideal partner from diagnostic development through clinical trials and regulatory submissions to commercialization. For more information, please contact Invivoscribe at: [email protected] or follow Invivoscribe on LinkedIn.
References
1. DaverN et al. Leukemia (2019) 33:299-312.
2. https://seer.cancer.gov/statfacts/html/amyl.html
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