FDA submission

It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.

The company intends to use the funds to support submission of its NGS assay to the FDA, adoption of its testing by more health systems, and continued R&D.

The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.

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.