Thermo Fisher's Oncomine Dx Express Test Receives FDA Approval

Thermo Fisher Scientific Inc. (NYSE:TMO) is one of the most undervalued large cap stocks to buy according to analysts. On July 3, Thermo Fisher Scientific announced that its Oncomine Dx Express Test, running on the Ion Torrent Genexus Dx Integrated Sequencer, has received approval from the US FDA.

The approval positions the test as an in vitro diagnostic/IVD assay for use as a companion diagnostic (CDx) for Dizal’s ZEGFROVY (sunvozertinib) and general tumor profiling. The FDA approval enhances Thermo Fisher’s precision oncology portfolio by enabling rapid next-gen sequencing/NGS in decentralized clinical settings.

The Oncomine Dx Express Test is capable of generating essential genomic insights in as little as 24 hours and is specifically intended as a companion diagnostic for ZEGFROVY (sunvozertinib), which is a targeted therapy from Dizal, to identify patients with non-small cell lung cancer//NSCLC harboring EGFR exon 20 insertion mutations. It has been approved for tumor profiling in solid tumors, detecting cancer mutations with evidence of clinical significance across 46 genes.

Thermo Fisher Scientific Inc. (NYSE:TMO) provides life sciences solutions, analytical instruments, specialty diagnostics, laboratory products, and biopharma services internationally.

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Disclosure: None. This article is originally published at Insider Monkey.