Thermo Fisher Scientific, a global life sciences company, announced it has signed new agreements with Daiichi Sankyo and Takeda Pharmaceuticals designed to expand the clinical utility of Oncomine Dx Target Test in support of clinical trials and drug development programs at each of the firms.
The agreements will focus on validating additional biomarkers and gene variants on the test and support Thermo Fisher’s commitment to further enable precision oncology.
Under the terms of the agreements, Thermo Fisher will retain global commercialization rights for the test and will lead all filings of supplemental premarket approvals (sPMA) in order to seek approval from the U.S. Food and Drug Administration (FDA). Expansion of Oncomine Dx Target Test aligns with the company’s strategic plan to further develop its test as a companion diagnostic (CDx) for multiple therapies.
To date, Thermo Fisher has multiple active sPMA programs in place to expand Oncomine Dx Target Test, including an agreement announced today by Spectrum Pharmaceuticals, and another to add the ALK gene, which is nearing completion. The company entered into CDx agreements with Agios Pharmaceuticals last year to validate the test to identify IDH1 mutations in cholangiocarcinoma patients, and with Blueprint Medicines to identify RET fusions in non-small cell lung cancer (NSCLC).
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 CDx for specific targeted therapies.