Foundation Medicine, Inc. is participating in the FDA - CMS Parallel Review Program. CMS received a formal request for a national coverage determination from Foundation Medicine Inc. This request is to establish coverage of comprehensive genomic profile testing for the management of cancer patients with solid tumors that are metastatic, including Stage IV and recurrent, with F1CDx™. F1CDx™ is a next generation sequencing based in vitro diagnostic device for detection of base substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements in 324 genes, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB), using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
Next generation sequencing is a technology to read the order of nucleotide molecules on DNA and more effectively provides detailed information on multiple types of genetic alternations simultaneously. The NGS oncology panel tests also provide patients and their providers a more comprehensive genetic profile of cancer and information relevant to potential cancer treatments. NGS oncology panel tests hold potential for patients and providers in optimizing (personalizing) therapies that target specific characteristics of individual patient cancers. However, it is important that these tests produce valid results that are useful in guiding therapies to improve outcomes for patients with advanced cancer.
CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.