Biotech Values

[DewDiligence]

(FMI)—FDA “authorizes” MSK’s IMPACT tumor-sequencing test:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585347.htm

The U.S. Food and Drug Administration today authorized Memorial Sloan Kettering Cancer Center’s (MSK) IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test (assay), an in vitro diagnostic test that can identify a higher number of genetic mutations (biomarkers) that may be found in various cancers than any test previously reviewed by the agency. The IMPACT test uses next-generation sequencing (NGS) to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a person’s tumor.

This sounds like serious competition for FMI’s FoundationOne test.