By Ron Shinkman, Editor, Laboratory Industry Report
Invivoscribe Technologies, a San Diego-based laboratory and equipment supplier, has entered into a companion testing pact with Astellas Pharma, Inc.
The deal will focus primarily on developing a diagnostic test focused on the FLT3 gene, which can be a biomarker for acute myeloid leukemia. Mutations in that particular gene can determine whether a patient will respond well to certain therapies.
That form of blood cancer is particularly deadly, with five-year survival rates hovering at around 20 to 25 percent, depending on the ethnic group. There are approximately 19,000 new cases diagnosed in the U.S. every year, and about 10,500 people die from the disease annually.
Under the terms of the deal, Invivoscribe will receive an upfront payment, reimbursement for certain development aspects of the test as well as regulatory and commercialization costs, and milestone payments. It will also assist Astellas in the enrollment of patients for clinical trials for potential new drugs. The specific financial terms of the deal were not disclosed.
“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, in a press release. "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."