Designation follows Thermo Fishers’ recent announcement on development of first companion diagnostic, using the Oncomine Precision Assay on the new Ion Torrent Genexus System. Credit: Thermo Fisher Scientific.

Thermo Fisher Scientific has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Oncomine Precision Assay.

The assay will identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881).

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It runs on the fully automated next-generation sequencing (NGS) platform Ion Torrent Genexus System, which is claimed to have a specimen-to-report workflow, offering comprehensive genomic profiling results in one day.

Thermo Fisher Scientific clinical next-generation sequencing and oncology president Garret Hampton 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.”

The company intends to obtain premarket approval (PMA) for the Oncomine Precision Assay as a companion diagnostic for multiple therapies along with approval for liquid biopsy tumour profiling in lung cancer and solid tissue tumour profiling in different cancer types.

Once cleared under PMA, the assay is anticipated to maximise detection of guideline-recommended biomarkers, including EGFR, ALK, KRAS, BRAF, ROS1, NTRK, RET, HER2 and others.

Thermo Fisher’s Genexus System is designed for application in multiple areas, including oncology, inherited disease, infectious disease and reproductive health. It has also been enabled to analyse SARS-CoV-2 samples to support epidemiology or contact-tracing studies.

Last week, Thermo Fisher expanded its strategic partnership agreement with Agios Pharmaceuticals to co-develop the companion diagnostic (CDx) for vorasidenib.

Vorasidenib is an investigational, oral, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 enzymes. It is currently under evaluation in the Phase III INDIGO study for IDH mutant LGG.