FDA Approves Precision Solid Tumor Cancer Diagnostics

(Arek Socha, Pixabay)

4 December 2017. The Food and Drug Administration approved genomic tests for solid tumor cancers that identify the most promising available therapies matched to the tumor’s genetic mutations. At the same time, a separate U.S. agency proposed that the cost of the tests, developed by Foundation Medicine in Cambridge, Massachusetts, should be covered for patients enrolled in Medicare.

The cancer tests, known as FoundationOne CDx, is a companion diagnostic that performs high-throughput genomic sequencing of DNA samples from cancer patients reporting on 324 genes most associated with tumor growth to help determine the most promising available treatments. FDA’s approval applies to patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer, or breast cancer where the results are matched to 15 treatment options approved for those conditions, including 12 first-line therapies, according to the company.

Foundation Medicine says FoundationOne CDx also evaluates indicators, such as microsatellite instability and tumor mutational burden that help determine benefits of immunotherapies and other specialized cancer treatments. Microsatellite instability is a defect in the repeating sequences of DNA preventing the repair of errors when DNA is copied in cells, and is associated with development of some solid tumors. Tumor mutational burden is a quantitative measure of the total number of mutations per coding error in a tumor genome. Tumors with a higher level of mutational burden are considered more likely to express immune-system targets specific to those tumors, making them better candidates for immunotherapies.

The company says based on its projections, 1 in 3 patients with the 5 types of solid tumors approved for FoundationOne CDx tests, can be matched to an FDA-approved treatment. Foundation Medicine says where treatments are not yet approved by FDA, the tests can identify clinical trials evaluating experimental therapies that match the patients’ tumor genomic profiles.

In a parallel action, Centers for Medicare and Medicaid Services, or CMS, in the U.S. Department of Health and Human Services, proposed that FoundationOne CDx and similar high-throughput genomic tests are eligible for reimbursement for patients with advanced cases of the 5 types of solid tumor cancers, who have not been previously tested. Final approval of Medicare coverage for these tests is expected in the first quarter of 2018, following a public comment period. The agencies say this is only the second diagnostic test to receive simultaneous FDA and CMS review and approval.

“This FDA approval,” says Andrea Ferris, CEO of LUNGevity Foundation in a company statement, “means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumor profile that can identify the therapies and clinical trials they could most benefit from. Along with the preliminary national coverage determination, this has the potential to democratize next-generation sequencing, lowering the barriers for patients treated in the community to access these biomarker-driven treatments.”

Foundation Medicine was founded in 2010 by genomics researchers at Dana-Farber Cancer Institute in Boston, Harvard Medical School, and Broad Institute, a medical research center affiliated with Harvard and MIT. As reported by Science & Enterprise in January 2015, drug maker Roche acquired a majority stake in Foundation Medicine, in a deal valued at more than $1 billion.

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