FDA Approves LeukoStrat CDx FLT3 Mutation Assay to Help Treat Patients with FLT3-ITD Positive AML with VANFLYTA

The U.S. Food and Drug Administration (FDA) has just given Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay the green light – an exciting development that will help doctors provide tailored treatment plans for patients with FLT3-ITD positive acute myeloid leukemia (AML), specifically with Daiichi Sankyo’s VANFLYTA® (quizartinib). This novel approach marks a major breakthrough that will give hope to newly diagnosed patients and their families.

The LeukoStrat CDx FLT3 Mutation Assay is a revolutionary test that enables doctors to identify AML patients who are eligible for targeted therapy with the recently approved FLT3-ITD inhibitor drug. This cutting-edge test could potentially be a game-changer for many patients fighting Acute Myeloid Leukemia.

US Intended Use

The LeukoStrat CDx FLT3 Mutation Assay is a powerful diagnostic tool that can be used to detect the presence of two highly prognostic genetic mutations, D835 and I836, in the FLT3 gene in the genomic DNA of patients diagnosed with acute myelogenous leukemia (AML).

Utilizing a PCR-based methodology, this assay can be used to detect these mutations in DNA samples taken from both peripheral blood and bone marrow aspirations. An invaluable diagnostic tool for healthcare providers, the LeukoStrat CDx FLT3 Mutation Assay allows for rapid and accurate detection of two major cell signaling pathways associated with AML.

The LeukoStrat CDx FLT3 Mutation Assay can provide valuable insights for clinicians considering RYDAPT® (midostaurin) treatment in patients diagnosed with AML. By allowing for the detection of mutations associated with this form of cancer, this advanced technology can help inform treatment decisions for the best possible outcomes.

The LeukoStrat CDx FLT3 Mutation Assay provides a valuable tool for healthcare practitioners evaluating patients with Acute Myeloid Leukemia (AML) for consideration of XOSPATA® (gilteritinib) therapy. This innovative genetic test offers a comprehensive analysis of the patient’s FLT3 mutation status, giving crucial insight into potential treatment plans and helping to ensure the best outcome for patients.

The LeukoStrat CDx FLT3 Mutation Assay is an invaluable tool for assessing patients with FLT3-ITD+ Acute Myeloid Leukemia, particularly in cases where VANFLYTA® (quizartinib) might be considered for treatment. This innovative assay provides essential insights to assist clinicians in making informed decisions about the best course of action for their patients.

The 3500xL Dx Genetic Analyzer is put to the test! See how it holds up in this rigorous analysis.

Invivoscribe is proud to collaborate with Daiichi Sankyo in order to bring the life-changing VANFLYTA treatment to newly diagnosed FLT3-ITD positive AML patients. The recently approved LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA, provides the timely and accurate testing required for the identification of eligible patients.

Jeffrey Miller, CSO, CEO, and founder of Invivoscribe, shares that this milestone is an important step forward in providing hope and a better outcome for those living with the disease.

Acute myeloid leukemia (AML) is a blood cancer that affects the blood and bone marrow, causing the rapid growth of abnormal white blood cells and one of the lowest 5-year survival rates (31.7%). As if this wasn’t daunting enough, around 25% of AML patients possess a mutation – FLT3-ITD – that makes a poor prognosis even worse through promoting the cancer cells’ growth and survival.

The LeukoStrat CDx FLT3 Mutation Assay, a groundbreaking diagnostic test, has been approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for selecting FLT3-ITD positive patients with acute myeloid leukemia (AML) who are eligible for treatment with VANFLYTA. This pioneering development brings a new hope to those fighting AML in Japan.

About Invivoscribe

Invivoscribe is a pioneering biotechnology company, relentlessly devoted to Improving Lives with Precision Diagnostics®. For 30 years, we’ve been dedicated to improving the quality of healthcare worldwide.

We offer specialized reagents, tests, and bioinformatics tools to make precision medicine more accessible; and we have a successful history of partnering with global pharmaceuticals for the development and commercialization of related diagnostics.

Our services also extend to distributable kits, as well as clinical trial support through our globally located clinical lab subsidiaries (LabPMM). Whatever the goal, from diagnostic development to regulatory submissions and commercialization – we are the ideal professional partner.

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