Molecular Diagnostic Testing for Hematology and Oncology ...

General Criteria for Somatic Mutation Genetic Testing ... initiate a related therapy and the therapy has been validated by the National Comprehensive Cancer Network™ (NCCN Guidelines™) as a category 1, 2A, or 2B recommendation for the ... Detection of circulating whole tumor cells for any other indication is considered experimental,

  Detection, Validated, Mutation

S2 (R1) Step 5 Genotoxicity testing and data ...

sensitivity for detection of rodent carcinogens and broadens the spectrum of genetic events detected, but also decreases the specificity of prediction; i.e., increases the incidence of …

  Detection

FoundationOne CDx Intended Use Table 1

Page 1 of 71 RAL-0003-12 FoundationOne®CDx Technical Information Foundation Medicine, Inc. 150 Second Street, Cambridge, MA 02141 Phone: 617.418.2200 Intended Use FoundationOne®CDx (F1CDx) is a qualitative next-generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology for …