Invivoscribe, a global leader in precision diagnostics, is pleased to announce the successful listings of the LeukoStrat CDx FLT3 Mutation Assay in both the United Kingdom (UK) and Switzerland. The LeukoStrat CDx FLT3 Mutation Assay aids in the accurate detection of FLT3 mutations, empowering clinicians to make informed treatment decisions. This milestone ensures expanded accessibility of critical treatments to patients diagnosed with acute myeloid leukemia (AML).
Regulatory compliance in the UK and Switzerland has been achieved through Invivoscribe's UK Responsible Person (UKRP) and Swiss Authorized Representative (CH-REP), ensuring full adherence to national regulatory frameworks. Both the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, and Swissmedic in Switzerland-have officially registered this CDx assay. These agencies are responsible for ensuring product safety, efficacy, and compliance with post-market surveillance requirements.
AML is an aggressive and rapidly progressing hematologic malignancy. Making timely and accurate detection of actionable mutations such as FLT3 is critical and essential for optimizing patient outcomes. The LeukoStrat CDx FLT3 Mutation Assay enables rapid same day results and precise identification of FLT3 mutations, which are associated with poor prognosis and targeted treatment options. By providing standardized, reliable and timely FLT3 mutation testing, the assay plays a critical role in precision medicine, helping guide therapeutic decisions and improving the management of AML worldwide.
This registration reinforces Invivoscribe's commitment to expanding access to high quality, regulatory compliant companion diagnostics that enable clinicians and patients to benefit from cutting-edge advancements in molecular testing.
