8 September 2020 - CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for Gavreto.

The U.S. FDA has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify RET fusion positive, metastatic non-small cell lung cancer patients who are candidates for Gavreto (pralsetinib), a targeted therapy developed by Blueprint Medicines. 

The Oncomine Dx Target Test was initially approved in 2017 as the first targeted next-generation sequencing (NGS)-based CDx for biomarkers associated with three FDA approved non-small cell lung cancer therapies. It is now also the first and only FDA approved test of its kind for a targeted treatment for RET fusion positive non-small cell lung cancer.

Thermo Fisher will update the Oncomine Dx Target Test to enable it to report RET fusions in the U.S. before the end of the year.

Read Thermo Fisher press release