Tumor profiling tests are increasingly influencing patient care. The F1CDx test is the second commercial next-generation sequencing-based test for cancer to be approved by FDA after the Oncomine Dx Target Test, the first in its class in June 2017. However, F1CDx is the first next-generation sequencing test for cancer to be reviewed as part of an FDA/CMS initiative designed to speed promising new technologies to market. By using this parallel review program FDA is able to bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer and/or other treatments to improve medical outcomes and potentially reduce health care costs., Along with the MSK-IMPACT authorization in November, FDA also announced a new, streamlined regulatory process that hospitals and medical institutions can use to secure FDA authorization for their own in-house tumor profiling tests without having to go directly through the agency, which can be expensive and time consuming.

Under the newly emerging concept of “One Clinical Trial, Many Cancer Types” clinical trials in cancer (also coined “basket trials”) are increasingly enrolling patients based not on the organ in which a tumor initially arose, such as the breast, colon, lung, or liver, but on the specific genetic alterations that allow the tumor to survive and spread. These targets can include mutations in single genes or genomic signatures such as microsatellite instability or mutation burden (the number of mutations in a single tumor).  Research published earlier this year showed that MSK-IMPACT identified actionable genetic changes in 37% of patients with advanced solid cancers. An actionable mutation is one that can be targeted with either an approved drug or one being tested in clinical trials. Taken together, patients with a variety of rare but actionable mutations do really add up to significant subsets of patients, and it would never be cost-effective to screen for these alterations one at a time.

Judge here for yourself the power of these new tests and the amount of actionable knowledge towards clinical therapy decisions generated by following  the impressive list of cancer types for which F1CDx can serve as a companion diagnostic:
Cancer Type Gene Containing Targeted Mutations Drug
Non-small cell lung cancer EGFR Erlotinib (Tarceva®), Afatinib (Gilotrif®), or Gefitinib (Iressa®)
Non-small cell lung cancer EGFR Osimertinib (Tagrisso®)
Non-small cell lung cancer ALK Crizotinib (Xalkori®), Alectinib (Alecensa®) or Ceritinib (Zykadia®)
Non-small cell lung cancer BRAF Dabrafenib (Tafinlar®) in combination with Trametinib (Mekinist®)
Melanoma BRAF Vemurafenib (Zelboraf®) or Dabrafenib
Melanoma BRAF Trametinib (Mekinist®) or Cobimetinib (Cotellic®) in combination with Vemurafenib (Zelboraf®)
Breast cancer HER2 (ERBB2) Trastuzumab (Herceptin®, Ogivri™), Pertuzumab (Perjeta®), or Ado-trastuzumab emtansine (Kadcyla®)
Colorectal cancer KRAS Cetuximab (Erbitux®)
Colorectal cancer KRAS, NRAS Panitumumab (Vectibix®)
Ovarian cancer BRCA1, BRCA2 Rucaparib (Rubraca®)

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