Tecentriq for small cell lung cancer – pro
FoundationOne is one of several panels of tumor markers designed to give the oncologist an option of treating in a personalized manner directed to the specific markers that the cancer expresses. FoundationOme is unique in that it is a pan-cancer profile – not restricted to one specific histology. It is a clinical diagnostic test based on sequencing from about 300 cancer related genes. This test includes all existing genes that are currently being tested for any type of cancer (BRCA1&2, KRAS, BRAF, HER2, EGFR, etc), but will include all exons and greater diagnostic sensitivity for mutations present in low abundance in heterogenous samples which may suffer from mixed tumor and normal tissue, multiple clones, mixed aneuploidy etc. It will likely also contain the majority of known pharmacogenomic genes.
FoundationOne claims to be highly accurate in identifying genomic alterations, including sensitivity greater than 99% for detection of base substitutions, 98% for detection of insertions and deletions, and greater than 95% for detection of copy number alterations, while maintaining greater than 99% specificity. Application of FoundationOne to 2,221 clinical cases revealed clinically actionable alterations in 76% of tumor samples, three times the number of actionable alterations detected by other currently available diagnostic tests. Alterations are defined as clinically actionable if linked to an FDA approved targeted therapy in the tumor under study or another solid tumor, a known or suspected contraindication to a given therapy, or an open clinical trial for which the alteration confers patient eligibility.
Unfortunately, there needs to be a prospective study that shows that this approach is better than standard current regimens. Performing panels of multiple tests, some actionable and some not, for cancers and situation in which clear guidelines for treatment already exist, had not been proven to provide clinical guidance and is not currently recommended by any guidelines.
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Ross JS, Ali SM, Wang K, Palmer G, Yelensky R, Lipson D, Miller VA, Zajchowski D, Shawver LK, Stephens PJ. Comprehensive Genomic Profiling Of Epithelial Ovarian Cancer By Next Generation Sequencing-Based Diagnostic Assay Reveals New Routes To Targeted Therapies. Gynocologic Oncology. 19 Jun 2013.