NEW YORK (GenomeWeb) – The New York State Department of Health has given its approval to Foundation Medicine to perform its FoundationOne and FoundationOne Heme tests on residents of New York State.
FoundationOne is a targeted genomic sequencing test for solid tumors that profiles the coding regions of 236 cancer-related genes, as well as 47 introns from 19 other genes for alterations associated with existing and experimental molecularly targeted therapies.
FoundationOne Heme specifically targets hematologic cancers such as leukemia, lymphoma, and myeloma, as well as sarcomas and pediatric cancers to guide treatment options for patients based on the genomic profiles of their cancer. The test involves sequencing of 405 full genes, select introns of another 31 genes, and RNA sequencing targeting 265 genes that are validated molecular targets for therapy or unambiguous drivers of oncogenesis in these cancers based on current knowledge.
According to Foundation Medicine, the two tests are the only fully informative genomic profiles to be approved by New York for the detection of all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations, and gene rearrangements.
Prior to this approval, the two tests were offered under conditional approval to physicians and their patients in New York.