Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML for Treatment with VANFLYTA

SAN DIEGO,July 21,2023 -- Invivoscribe is excited to announce that the LeukoStrat®CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib).

The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3-ITD positive AML patients who may be treated with this newly approved targeted therapy.

US Intended Use

The LeukoStrat CDxFLT3Mutation 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 theFLT3gene 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 CDxFLT3Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered.

The LeukoStrat CDxFLT3Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered.

The LeukoStrat CDxFLT3Mutation Assay is used as an aid in the assessment of patients withFLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered.

The test is for use on the 3500xL Dx Genetic Analyzer.

"FDA approval of the LeukoStrat CDx FLT3Mutation Assay as a companion diagnostic to VANFLYTA is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML," said Invivoscribe CSO,CEO,and founder Jeffrey Miller. "Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with VANFLYTA,and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients."

AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 About 25% ofAML patients have a FLT3-ITD mutation which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.3

Previously,the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select FLT3-ITD positive AML patients eligible for VANFLYTA in Japan.

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 global pharmaceutical companies interested in developing and commercializing companion diagnostics,and provides 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. For additional information,please visit www.invivoscribe.com or contact us at inquiry@invivoscribe.com and follow us on LinkedIn.

1https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/introduction

2https://seer.cancer.gov/statfacts/html/amyl.html

3 Daver N et al. Leukemia (2019) 33:299–312.