Foundation Medicine up for expedited review by FDA, CMS

Foundation Medicine’s ($FMI) FoundationOne tech has been accepted for Parallel Review by both the U.S. FDA and the Centers for Medicare and Medicaid Services (CMS), which is believed to conclude in the second half of 2017. The tech will also be reviewed as part of the FDA’s Expedited Access Pathway (EAP).

FoundationOne is a comprehensive genomic profiling (CGP) assay. The assay detects genomic alterations by using next-generation sequencing and computational analysis. The alterations--such as substitutions, insertions and deletions--can be found in 324 genes via DNA that is isolated from formalin-fixed paraffin-embedded tumor tissue specimens.

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If approved by the FDA, it would be the first of its kind to incorporate multiple companion diagnostics to aid precision medicine in oncology. Should the tech receive Medicare National Coverage Determination (NCD) from the CMS at the same time as FDA approval, FoundationOne would be a covered benefit under Medicare. This would eliminate a time gap that happens between FDA and NCD approvals.

"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," said Michael Pellini, chief executive officer of Foundation Medicine, in a statement. Pellini explained that Foundation Medicine will continue to work with Palmetto GBA, its Medicare Administrative Contractor in North Carolina and a thought leader in molecular diagnostics.

“Specifically, we will work with Palmetto through its MolDx Program to expand coverage of well-validated CGP assays, such as FoundationOne, to include additional cancer indications beyond the existing local coverage determination (LCD), which currently covers a subset of patients with non-small cell lung cancer (NSCLC),” Pellini continued.

FoundationOne, if approved, could be used to help identify patients who could benefit from treatment for solid tumor malignancies. “FoundationOne will also be intended to provide treating physicians with important information, including cancer-related variants and molecular signatures to inform molecular eligibility for clinical trials or treatment management according to clinical care guidelines,” Foundation Medicine explained in the announcement.

"Beyond its application in cancer care, an FDA-approved FoundationOne incorporating multiple companion diagnostics would provide a significant and highly differentiated offering for our biopharma partners,” Pellini said in a statement. “We believe this approach, which is designed to expedite approval of additional biomarkers on FoundationOne, both accelerates and de-risks companion diagnostic approval for our biopharma partners seeking a coordinated regulatory strategy for therapeutic drug approval."

Foundation Medical has also released second quarter financial and operational results. In the second quarter, revenue totaled $28.2 million and Foundation Medical reported 10,286 clinical tests.

Foundation Medical also grew FoundationCORE, the molecular information knowledgebase, and commercially launched FoundationACT, the company’s circulating tumor DNA assay.

- here is the press release

Special Report: Foundation Medicine – 2012 Fierce 15

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