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FDA submission

The final guidance is an update to an agreement between the FDA and CMS, which uses the FDA's policy in determining coverage for investigational devices. 

The company expects the new trials to start this fall, and plans to submit to the FDA next year to get the agency's stamp of approval.

The firm anticipates receiving regulatory approval from the CFDA for its first three products by the end of the year, including one for lung cancer.

Company highlights during the first half of 2017 include China approval for Novaprep for non-gynecological cancer testing, and a €3 million private financing round. 

The firm's real-time PCR-based GeneStat system was developed leveraging IP licensed exclusively from the Translational Genomics Research Institute.

The test, which is currently for research use only, uses fluorescent multiplex PCR to co-amplify seven markers for analysis of the MSI-high phenotype.

Thermo Fisher developed the NGS-based multi-marker assay in collaboration with Novartis and Pfizer to match lung cancer patients with targeted drugs.

Despite lower than expected NGS instrument sales, Illumina expects continued growth in the oncology market as reimbursement increases. 

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