Thermo Fisher Prepares for NGS Cancer Testing with Pharma Partners

By Bio-IT World Staff

November 20, 2015 | Thermo Fisher Scientific announced this week that it will be creating a next-generation sequencing test as a companion diagnostic in cases of non-small cell lung cancer (NSCLC). The test, developed in cooperation with Novartis and Pfizer, will sequence multiple genes that can be used to select targeted NSCLC therapies.

Unlike most companion diagnostics, Thermo Fisher’s will not be tied to a specific drug.

Thermo Fisher has listed one of its next-generation sequencers, the Ion PGM Dx, for clinical use under the FDA’s Class 2 exemptions. The new NSCLC multi-gene test will be designed for this instrument, giving it a straightforward path to FDA clearance as an in vitro diagnostic, unlike the laboratory-developed tests currently used for the same purpose. As cancer quickly becomes one of the hottest areas for broad genetic testing, companies like Thermo Fisher are creating proprietary cancer panels that they can distribute broadly with the FDA’s approval, in order to make their clinical sequencers as useful as possible for labs that do not or cannot create tests in-house.

Illumina of San Diego, the largest manufacturer of DNA sequencers, established a similar pharma partnership for companion diagnostics in cancer last September, collaborating with AstraZeneca, Sanofi, and Johnson & Johnson. That project has produced a panel called TruSight Tumor 15, currently marketed for research use only, covering 15 genes relevant to the treatment of solid tumors. Illumina also has a separate cancer diagnostics agreement with Merck Serono.

The Ion PGM Dx and Illumina’s MiSeqDx are the only next-generation sequencers that have been listed or cleared for clinical use so far. Meanwhile, diagnostics company QIAGEN has made a wide-ranging cancer panel the centerpiece of its own newly-launched sequencer, the GeneReader.