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Thermo Fisher Submits Premarket Approval Application to FDA for Sequencing-Based Companion Dx

NEW YORK (GenomeWeb) – Thermo Fisher Scientific has submitted a premarket approval application to the US Food and Drug Administration for a next-generation sequencing-based companion diagnostic, the company said today.

The firm submitted an application for its Oncomine Universal Dx test for non-small cell lung cancer that it developed in partnership with Novartis and Pfizer. The test will use the Ion AmpliSeq technology and run on the Ion Torrent PGM Dx system.

"As pharmaceutical companies shift toward developing new targeted therapies as opposed to "one-size-fits-all" drugs, there is a clear need to more efficiently stratify cancer patients and tailor their treatments to enable better health outcomes," Joydeep Goswami, president of clinical next-generation sequencing at Thermo Fisher, said in a statement.

The universal CDx would analyze multiple markers from a formalin-fixed paraffin-embedded tumor sample and would deliver results in five days with 10 nanograms of DNA, according to Thermo Fisher.

The PMA submission includes clinical and analytical claims associated with NSCLC biomarkers following clinical trials completed by Novartis and Pfizer. In addition, representatives from Thermo Fisher, Pfizer, and Novartis said at a recent conference that other pharmaceutical companies could join in the collaboration, since the CDx likely includes targets being investigated by other pharma firms. The companies also plan to work together to market the assay.

Illumina is also developing a universal CDx in collaboration with AstraZeneca, Janssen Biotech, and Sanofi. Illumina has not yet submitted a PMA for the universal CDx to the FDA, but earlier this month said that it had submitted a separate CDx that it developed with Amgen to the FDA.