Invivoscribe Publicizes Registration of the LeukoStrat® CDx FLT3 Mutation Assay in the UK and Switzerland

SAN DIEGO — Invivoscribe, a worldwide chief in precision diagnostics, is happy to announce the profitable listings of the LeukoStrat CDx FLT3 Mutation Assay in each the UK (UK) and Switzerland. The LeukoStrat CDx FLT3 Mutation Assay aids within the correct detection of FLT3 mutations, empowering clinicians to make knowledgeable remedy selections. This milestone ensures expanded accessibility of vital therapies to sufferers identified with acute myeloid leukemia (AML).

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Regulatory compliance within the UK and Switzerland has been achieved via Invivoscribe’s UK Accountable Individual (UKRP) and Swiss Licensed Consultant (CH-REP), guaranteeing full adherence to nationwide regulatory frameworks. Each the Medicines and Healthcare merchandise Regulatory Company (MHRA) within the UK, and Swissmedic in Switzerland—have formally registered this CDx assay. These businesses are liable for guaranteeing product security, efficacy, and compliance with post-market surveillance necessities.

AML is an aggressive and quickly progressing hematologic malignancy. Making well timed and correct detection of actionable mutations similar to FLT3 is vital and important for optimizing affected person outcomes. The LeukoStrat CDx FLT3 Mutation Assay permits speedy identical day outcomes and exact identification of FLT3 mutations, that are related to poor prognosis and focused remedy choices. By offering standardized, dependable and well timed FLT3 mutation testing, the assay performs a vital function in precision medication, serving to information therapeutic selections and bettering the administration of AML worldwide.

This registration reinforces Invivoscribe’s dedication to increasing entry to top quality, regulatory compliant companion diagnostics that allow clinicians and sufferers to learn from cutting-edge developments in molecular testing.

For extra details about the LeukoStrat CDx FLT3 Mutation Assay and Invivoscribe’s complete portfolio of precision diagnostics, please go to www.invivoscribe.com or contact us at inquiry@invivoscribe.com and comply with us on Linked In.

EU Supposed Use

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic check designed to detect inner tandem duplication (ITD) and tyrosine kinase area (TKD) mutations D835 and I836 within the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of sufferers identified with acute myelogenous leukemia (AML). The LeukoStrat CDx FLT3 Mutation Assay could also be used as a companion diagnostic for the next therapeutic:

In areas the place XOSPATA^® (gilteritinib fumarate) is out there, the LeukoStrat CDx FLT3 Mutation Assay is used as an support within the evaluation of sufferers with AML for whom XOSPATA^® (gilteritinib fumarate) remedy is being thought of.

In areas the place VANFLYTA^® (quizartinib hydrochloride) is out there, the LeukoStrat CDx FLT3 Mutation Assay is used as an support within the evaluation of sufferers with FLT3-ITD+ AML for whom VANFLYTA^® (quizartinib hydrochloride) remedy is being thought of.

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The qualitative, non-automated check is to be used on the 3500xL or 3500xL Dx Genetic Analyzers.

About Invivoscribe

Invivoscribe is a worldwide, vertically built-in biotechnology firm devoted to Enhancing Lives with Precision Diagnostics^®. For practically thirty years, Invivoscribe has improved the standard of healthcare worldwide by offering top quality standardized reagents, exams, and bioinformatics instruments to advance the sphere of precision medication. Invivoscribe has a profitable monitor file of partnerships with pharmaceutical corporations curious about medical trial testing by way of our international lab community positioned within the US, Germany, Japan and China, and in growing and commercializing companion diagnostics, with our rigorous experience in each regulatory and laboratory providers. Offering distributable kits, in addition to medical trial providers via its globally positioned medical lab subsidiaries (LabPMM), Invivoscribe is a perfect associate from diagnostic growth, via medical trials, regulatory submissions, and commercialization.