Thermo Fisher Scientific Cancer Diagnostic Approved

The FDA has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic to identify metastatic nonsmall-cell lung cancer (mNSCLC) patients who might benefit from Takeda Pharmaceutical’s Exkivity (mobocertinib), which has also just received approval from the agency.

The diagnostic zeroes in on epidermal growth factor receptor Exon20 insertion mutations that can trigger the cancer. Conventional polymerase chain-reaction diagnostic methods can miss 50 percent or more of the gene mutations, the company said.

The Oncomine Dx Target Test has now been approved as a companion diagnostic for a total of five targeted NSCLC therapies.