EU Notified Body (BSI Netherlands) and the EMA Grant Approval of the LeukoStrat® CDx FLT3 Mutation Assay for VANFLYTA® Therapy in the EU and EEA

SAN DIEGO--(BUSINESS WIRE)--Invivoscribe is excited to announce that their CE-2797 IVD certified LeukoStrat^® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA to aid in the selection of individuals in the European Union and European Economic Area with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA^® (quizartinib). BSI, a Notified Body accredited in the EU, is authorized to assess and certify In-Vitro Diagnostics (IVDs), ensuring product compliance with European directives and regulations.

Invivoscribe continues to lead the way in developing standardized diagnostic tools that enable tailored treatment strategies, ultimately aiming to enhance the quality of life for individuals battling this aggressive form of leukemia.

“Targeting driver mutations linked to new therapies such as VANFLYTA^®, is key to improving the lives of AML patients,” said Jason Gerhold, Invivoscribe’s V.P. of Global Regulatory, Quality and Clinical Affairs. “Invivoscribe’s Class C CDx assay is now approved by BSI as a CE-marked IVD, offering oncologists another tool to ensure that their patients are provided optimal treatments.”

AML is a blood cancer characterized by the rapid growth of abnormal white blood cells¹ and has the lowest 5-year survival rate (31.9%) among people diagnosed with leukemia.² About 25% of AML patients have a FLT3-ITD mutation, which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.³

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, bioinformatics tools, and services to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies, providing expertise in diagnostic development and regulatory submission through commercialization of companion diagnostics. For additional information, please visit www.invivoscribe.com or contact us at [e-mail] and follow us on LinkedIn.

¹ https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/introduction
² https://seer.cancer.gov/statfacts/html/amyl.html. Accessed 12 August 2024.
³ Daver N et al. Leukemia (2019) 33:299–312.