Thermo Fisher’s Oncomine Precision Assay gets FDA Breakthrough Device Designation

The FDA has granted Breakthrough Device Designation to Thermo Fisher Scientific’s Oncomine Precision Assay to identify low-grade glioma patients with isocitrate dehydrogenase 1 and 2 mutations who may be eligible for vorasidenib (AG-881). The assay runs on the new Ion Torrent Genexus System, the first fully automated next-generation sequencing platform with a specimen-to-report workflow that delivers comprehensive genomic profiling results in one day. The company will apply for premarket approval for the Oncomine Precision Assay as a companion diagnostic for multiple therapies, as well as approval for liquid biopsy tumor profiling in lung cancer and solid tissue tumor profiling in multiple cancer types, in due course. When PMA is received, the Oncomine Precision Assay will maximize detection of guideline-recommended biomarkers like EGFR, ALK, KRAS, BRAF, ROS1, NTRK, RET and HER2.

Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, said: “Breakthrough designation for the companion diagnostic is a big step forward in our endeavour to ensure that more clinicians can have quicker access to comprehensive genomic information. Receiving this insight at the speed that the Genexus System enables can help expedite patient therapy selection, which is a critical need in the clinic today.”

Dr. Alain Mita, Associate Professor of Medicine, Co-Director of the Experimental Therapeutics Program at Cedars-Sinai Medical Centre, said: “Access to timely, comprehensive genomic profiling data that supports well-informed treatment decisions can be challenging under the current cancer-testing paradigm. The possibility of having multi-biomarker profiling that is generated onsite and available in about a day is game-changing for the manner and speed in which oncologists are able to determine and prescribe the most appropriate treatment for their patients.”