SAN DIEGO, CA--(Marketwired) - Invivoscribe® Technologies, Inc., a company with international experience commercializing in vitro diagnostic tests and developing companion diagnostics, today announced they have entered into a companion diagnostic agreement with Astellas Pharma Inc.
Invivoscribe will develop and commercialize a companion diagnostic for FLT3 and use the internationally harmonized signal ratio test to stratify and enroll acute myeloid leukemia patients for Astellas' investigational trials of its targeted drug ASP2215 in the United States, Europe, Japan and certain other countries.
Invivoscribe will receive an upfront payment, reimbursement for certain development, regulatory and commercialization costs, as well as milestone payments for completion of certain of the development, regulatory and commercialization related goals. Invivoscribe is responsible for development of the companion diagnostic, regulatory submissions, approval of the test in the designated territories, and international commercialization activities, including those in the United States, Europe, and Japan.
"We are looking forward to this expanded use of our harmonized companion diagnostic around the FLT3 biomarker," said Dr. Jeffrey E. Miller, CEO and Chairman of Invivoscribe. "This signal ratio assay is an internationally recognized test for identifying patients with FLT3 mutations and an important tool for stratifying cytogenetically normal AML. We are very pleased to be partnering with Astellas, a global pharmaceutical leader, to deliver this companion diagnostic for their investigational drug."
This is Invivoscribe's second partnership with a major pharmaceutical company to develop a companion diagnostic for the FLT3 biomarker.
About Acute Myeloid Leukemia (AML) and FLT3
According to the Leukemia & Lymphoma Society®, there are approximately 18,860 new AML cases in the US per year, and the disease causes 10,460 deaths annually -- a death rate (55%) that is significantly higher than for other leukemias. FLT3 mutation status is typically determined for AML patients as a part of the standard of care. The World Health Organization (WHO), the American Society of Clinical Oncology, the National Comprehensive Cancer Network and European Leukemia Net recommend FLT3 testing, as FLT3 mutation status helps predict a patient's likelihood to respond to therapy as well as the risk of recurrence. Internal tandem duplications within the FLT3 gene can lead to increased activity of the FLT3 tyrosine kinase, resulting in a poorer prognosis for this disease. This kinase has been the focus of targeted treatment by a number of pharmaceutical companies.
Invivoscribe, Inc. is a privately held biotechnology company dedicated to improving the lives of patients around the world by providing cutting edge tools to diagnose, stratify, and monitor patients who suffer from hematologic disease. Invivoscribe provides ISO13485 certified GMP manufactured PCR- and NGS-based reagents, RUO test kits, CE-marked IVDs, including IdentiClone®, LymphoTrack® and LymphoTrack® Dx assays for clonality and somatic hypermutation testing. Invivoscribe's wholly owned affiliates, Genection(tm) and LabPMM® laboratories, provide international access to harmonized CLIA, CAP and ISO15189 compliant clinical testing and CRO services. Their test menu includes MyAML(tm), an advanced AML-specific NGS gene panel that is used with their proprietary MyInformatics(tm) bioinformatics pipeline and database to identify and track the clonal and subclonal architecture and somatic mutation status of 194 AML-associated genes. For more information about Invivoscribe, visit www.invivoscribe.com.
Invivoscribe Technologies, Inc.
Vice President, Global Commercial Operations
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