On April 28, 2015 Invivoscribe Technologies reported that it has signed an agreement with Astellas Pharma to develop a companion diagnostic for an investigational drug (Press release, Invivoscribe Technologies, APR 28, 2015, View Source [SID1234550141]).

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Under the terms of the agreement, Invivoscribe will develop and commercialize a companion diagnostic based on the FLT3 tyrosine kinase gene and use the international harmonized signal ration test to stratify and enroll acute myeloid leukemia (AML) patients for Astellas clinical trials of the drug candidate ASP2215 in the US, Europe, Japan, and other countries.

San Diego-based Invivoscribe will receive an upfront payment; reimbursements for development, regulatory, and commercialization costs; and milestone payments for reaching certain goals. The firm will be responsible for all development, commercialization, and regulatory activity in the US, Europe, and Japan.

FLT3 mutation status is typically determined for AML patients as a part of the standard of care, the firm said in a statement.

"We are looking forward to this expanded use of our harmonized companion diagnostic around the FLT3 biomarker," Invivoscribe Chairman and CEO Jeffrey Miller said in a statement. "This signal ratio assay is an internationally recognized test for identifying patients with FLT3 mutations and an important tool for stratifying cytogenetically normal AML."

In 2011, Invivoscribe signed a companion diagnostics partnership with Novartis based on the FLT3 gene for AML.