FDA approves key genetic/genomic test for cancer mutations


According to reports from the Associated Press and others, some time late last Thursday the  US Food & Drug Administration (FDA) appears to have approved the use of the FoundationOne CDx genetic/genomic test for patients with “advanced or widely spread cancers.” A media release from Foundation Medicine is also available on line.

This is a big deal for practical, day-to-day clinical progress in the field of personalized/precision cancer medicine because, according to Dr. Kate Goodrich, who is the chief medical officer at the Center for Medicare and Medicaid Services (CMS), the FoundationOne test can be used to assess risk for the presence of

mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws.

The actual number of mutations that the FoundationOne test can currently identify is 324 (according to Health Finance News), and Medicare has already agreed to cover the costs of this test for appropriate patients (which will include many prostate cancer patients with advanced or metastatic disease).

We should also note that the FDA was able to approve the use of this test within 6 months of receipt of the product application through the use of the FDA-CMS Parallel Review Program.

6 Responses

  1. I have heard directly from FM. … The test has been approved.

  2. I may be reading this (and the CMS and Foundation Medicine’s press releases) incorrectly, but I think this ‘CDX’ test is specifically for ovarian cancers. Foundation Medicine doesn’t mention their other tests (Foundation One, Foundation Act (liquid biopsy) and FoundationHEME) as being Medicare approved (yet).

  3. This is wonderful news, but disappointing that they only do the analyses on traditionally biopsied tissue and they do not perform liquid biopsies.

  4. Dear J-P:

    No. your interpretation is not correct. See this paragraph from the Foundation Medicine media release:

    “FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and, relevant clinical trial information.”

    The bold type indicates an emphasis added by yours truly!

    The FoundationOne CDx test is not yet approved explicitly as a companion diagnostic associated with any specific treatment for prostate cancer, but it is being used as a diagnostic test for patients being enrolled into clinical trials of PARP inhibitors in the treatment of late stage prostate cancers, and I would expect it to be approved as a companion diagnostic test for the identification of appropriate prostate cancer patients as and when one or more of the PARP inhibitors does get approval for the treatment of appropriately identified patients.

    Foundation Medicine does have other tests that are in development and I am sure at least some of those tests will become commercially available as this field expands.

  5. Len: These tests are in the works and are in clinical trials. One step at a time! :O)

  6. Thanks for setting me straight, Mike. I didn’t see a FoundationOne CDX test mentioned on their site until today. Prior to this, the only one with CDX in the title was the BRCA test for ovarian tumors and that’s what confused me. This is why I depend on you and Rick to keep me straight!

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