The U.S. Food and Drug Administration (FDA) has approved a new genetic test that can detect 324 different genes that are known to be involved in 5 different cancer types: non-small cell lung cancer (NSCLC), melanoma, breast cancer, colorectal cancer, and ovarian cancer. The test is called the FoundationOne CDx (F1CDx) and is made by the company Foundation Medicine Inc. in Cambridge, Massachusetts. Prior to this, genetic testing was done on single mutations at a time.1
In addition to the FDA approval, the Centers for Medicare & Medicaid Services has proposed national coverage of the test. The combined efforts of the two departments aim at providing patients faster access to breakthrough technologies, and with tests like the F1CDx, doctors can tailor cancer treatments to improve their patients’ outcomes and potentially reduce health care costs.1
About the Test
The F1CDx is an extensive genetic test that provides results on a number of different possible genetic mutations in 324 genes that are known to cause cancer, including EGFR, KRAS, BRAF, BRCA1/2, ALK and NTRK1/2/3.2,3 By knowing which genetic mutations are present in a tumor, doctors can recommend targeted treatments. In addition to identifying which patients may benefit from targeted treatments, the F1CDx results can also provide opportunities for potential clinical trials that patients may be eligible to participate in.2
In clinical trials of the F1CDx, the test was able to detect mutations approximately 94.6% of the time for each of the 324 genes. The types of mutations the F1CDx test can detect include:
Substitutions, in which one part of the DNA is switched with another
Insertions, in which there is extra information in the DNA
Deletions, in which part of the DNA is missing
About Genetic Mutations and Cancer
Changes to the DNA (mutations) may be passed down from parents to children (inherited genes), or they may occur from exposure to certain factors in the environment. Each time any cell in the body divides, it makes a new copy of its DNA. Sometimes errors occur during this replication. These errors can cause the cell to develop abnormally and may lead to the development of cancer through the activation of oncogenes (cancer genes) or the suppression of tumor suppressor genes. Oncogenes cause the cells to replicate more, creating cancer cells. Tumor suppressor genes are normally a stop mechanism that cause damaged cells to die or slow cell growth. When tumor suppressor genes are turned off, cancer cells can replicate more easily.4
About Targeted Therapies
Targeted therapies are cancer treatments that stop or slow the spread of cancer by interfering with specific molecules that are involved in the cancer cell’s growth processes. Unlike chemotherapy, which targets all cells that divide and grow quickly, targeted therapies focus on specific features of cancer cells in an effort to provide treatment that does less damage to normal cells and causes fewer side effects.5,6
There are currently 17 approved targeted therapies for the five cancer types covered by the F1CDx, and 12 of those therapies are currently approved for first-line treatment. Based on previous research by Foundation Medicine, it is estimated that approximately 1 in every 3 patients across the five cancer types will match with an FDA approved targeted therapy.2
FDA press release. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587273.htm. Accessed 12/4/17.
Foundation Medicine press release. Available at http://investors.foundationmedicine.com/releasedetail.cfm?ReleaseID=1050380. Accessed 12/4/17.
FDA Approves FoundationOne CDx, OncLive. Available at http://www.onclive.com/web-exclusives/fda-approves-foundationone-cdx-cms-agrees-to-cover-for-medicare-beneficiaries. Accessed 12/4/17.
American Cancer Society. Available at https://www.cancer.org/. Accessed 12/4/17.
Chemocare. Available at http://chemocare.com/chemotherapy/what-is-chemotherapy/targeted-therapy.aspx. Accessed 12/4/17.
National Cancer Institute. Available at https://www.cancer.gov/. Accessed 12/4/17.