FoundationOne test – 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. FoundationOne 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 heterogeneous 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.
Per the U.S. FDA (2019), “FoundationOne CDx (F1CDx) is a laboratory test designed to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor. F1CDx is a companion diagnostic used to identify patients with certain genetic mutations who MAY benefit from FDA-approved treatments for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer…F1CDx can help doctors identify patients who MAY benefit from treatment with targeted therapies for a variety of cancer types (listed above). This test provides profiling information on a number of different cancer tumor mutations that may help in the clinical management of oncology patients. This is an important advancement, because it allows patients and health care providers to access all of this information in one test report, and avoid duplicative biopsies.”
NCCN used to recommend genetic testing for lung, bladder and some ovarian cancers, although not naming any specific test. However, in April 2020. it added a broad, non-cancer specific recommendation, Version 4.2020, “The NCCN Panel recommends that metastatic disease at presentation or first recurrence of disease should be biopsied as a part of the workup for patients with recurrent or stage IV disease. This ensures accurate determination of metastatic/recurrent disease and tumor histology, and allows for biomarker determination and selection of appropriate treatment. Soft tissue tumor biopsy is preferred over bone sites unless a portion of the biopsy can be protected from harsh decalcification solution to preserve more accurate assessment of biomarkers. ….Genetic testing: In the metastatic setting, results from genetic testing may have therapeutic implications.
Wafik S. ElDeiry et al, The current state of molecular testing in the treatment of patients with solid tumors, 2019. CA-Cancer Journ Clin Volume69, Issue4 July/August 2019 Pages 305-343
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NCCN NSC Lung Cancer 2021