SAN DIEGO–(BUSINESS WIRE)–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.
For more information about the LeukoStrat CDx FLT3 Mutation Assay and Invivoscribe’s comprehensive portfolio of precision diagnostics, please visit www.invivoscribe.com or contact us at [email protected] and follow us on Linked In.
EU Intended Use
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). The LeukoStrat CDx FLT3 Mutation Assay may be used as a companion diagnostic for the following therapeutic:
In regions where XOSPATA® (gilteritinib fumarate) is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib fumarate) treatment is being considered.
In regions where VANFLYTA® (quizartinib hydrochloride) is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib hydrochloride) treatment is being considered.
The qualitative, non-automated test is for use on the 3500xL or 3500xL Dx Genetic Analyzers.
About Invivoscribe
Invivoscribe is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has improved 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 partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the US, Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.
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