NEW YORK (GenomeWeb) – Thermo Fisher Scientific has signed agreements with Daiichi Sankyo and Takeda Pharmaceuticals to use its Oncomine Dx Target Test in clinical trials and drug development programs.
Under the terms of those partnerships, Thermo will validate additional biomarkers and gene variants on Oncomine and retain global commercialization rights for the test. The company will also be responsible for filing supplemental premarket approval applications with the US Food and Drug Administration.
According to Thermo, it has multiple active sPMA programs in place to expand the use of its test, including an effort to add evaluation of the ALK gene to the panel, and a separate agreement announced today with Spectrum Pharmaceuticals.
The agreement with Spectrum is focused on advancing Oncomine as a companion diagnostic for its pan-HER inhibitor poziotinib as a treatment for non-small lung cancer patients with EGFR and HER2 exon 20 insertion mutations. "As promising clinical data continue to emerge with poziotinib for the treatment of patients [with these mutations], the expansion of Oncomine … will aid in faster detection and future treatment of patients who are not well served by currently available therapies," Tom Riga, Spectrum's chief operating and commercial officer, said in a statement.
Oncomine was approved by the FDA last year to analyze 23 genes clinically associated with NSCLC, and three markers are approved as companion diagnostics to identify best responders to targeted lung cancer treatments. The test is offered by several national reference laboratories including LabCorp's Diagnostics and Covance businesses, Quest Diagnostics, Cancer Genetics, and NeoGenomics Laboratories, and has garnered positive coverage decisions from the Centers for Medicare & Medicaid Services and a number of private payors.