The US Food and Drug Administration today approved the first next-generation sequencing-based companion diagnostic that can analyze alterations in a panel of genes predictive of response across three non-small cell lung cancer treatments.
The panel, however, gauges alterations in 23 genes in total. The test report will not only indicate whether patients have ROS1, EGFR, and BRAF alterations linked to the three FDA-approved treatments, but also the presence or absence of variants in other genes.
This initial approval makes way for Thermo Fisher to quickly expand the indication of the panel into new markers predictive of drug response. The company is actively working with other drugmakers to expand the indications for the Oncomine Dx Target Test.
Read the entire article at Genome Web.