May 4, 2018—Thermo Fisher Scientific has signed agreements with Daiichi Sankyo and Takeda Pharmaceuticals designed to expand the clinical utility of the Oncomine Dx Target Test in support of clinical trials and drug development programs at the Japanese companies. The agreements will focus on validating additional biomarkers and gene variants on the test. Under the terms of the agreements, Thermo Fisher will retain worldwide commercialization rights for the test and will lead all filings of supplemental premarket approvals to seek approval from the FDA.
“We are extremely pleased with the strong interest and commitment from our pharmaceutical partners who see the value of leveraging the expandability of Oncomine Dx Target Test,” Joydeep Goswami, president of clinical next generation sequencing and oncology at Thermo Fisher Scientific, said in a statement. “This unique feature can help expedite their drug development programs so that patients potentially benefit more quickly from the targeted therapies in the development pipeline.”
Oncomine Dx Target Test is FDA approved to simultaneously report 23 genes clinically associated with NSCLC. Of those 23, three contain markers that are approved for use as a companion diagnostic for specific targeted therapies. Since receiving FDA approval last year, the test has received positive reimbursement decisions from the Centers for Medicare and Medicaid Services and from large commercial health insurers.