Foundation Medicine Applies for Parallel FDA and CMS Review for CGP Test

Foundation Medicine’s comprehensive genomic profiling (CGP) assay has been submitted by the company for FDA review as well as for a CMS review in parallel.

Foundation Medicine’s comprehensive genomic profiling (CGP) assay has been submitted by the company for FDA review as well as for a CMS review in parallel, according to a company

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press release

The FoundationOne CGP assay for cancer can evaluate genomic alterations in 324 genes from formalin-fixed tissue samples mounted in paraffin. CGP is tasked to detect substitutions, insertions and deletions, copy number alterations, and select gene rearrangements using next-generation sequencing, which could prove a big benefit for patients who have developed solid tumors. A bigger advantage thought would be the precision medicine plan that could eventually be developed to match the patient with appropriate treatment.

The company’s chief executive officer Michael Pellini, MD, said, “The acceptance of FoundationOne for EAP and Parallel Review is a significant advancement towards the achievement of precision medicine, enhancing patient access to targeted therapies and clinical trials.” He added that Foundation Medicine will continue to work with Palmetto GBA to expand coverage of CGP assays, currently restricted to patients with non-small cell lung cancer.