FDA/CDC

Breakthrough cancer gene assay approved, CMS proposes coverage


 

The Food and Drug Administration approved a new genetic sequencing test that detects mutations across 324 genes in tumor biopsy specimens with an accuracy of 94.6%.

The FoundationOne CDx (F1CDx) test from Foundation Medicine “can identify which patients with any of five tumor types” – non–small-cell lung cancer, melanoma, breast cancer, colorectal cancer, or ovarian cancer – “may benefit from 15 different FDA-approved targeted treatment options,” as well as clinical trial eligibility, “with one test report, avoiding duplicative biopsies,” the agency said in a statement.

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Previously approved tumor sequencing assays matched one test to one drug. The FDA granted F1CDx “breakthrough device” status because of its ability to consolidate testing.

On the same day as the approval, the Centers for Medicare & Medicaid Services proposed nationwide coverage for Medicare beneficiaries with recurrent or metastatic disease. CMS is accepting public comments on the proposal for 30 days. The cost of the test is $5,800.

F1CDx went through the FDA and CMS Parallel Review Program, in which the agencies review medical devices concurrently to help reduce the time between approval and Medicare coverage.

F1CDx reads the order of nucleotides on DNA isolated from biopsy specimens to detect a range of genetic anomalies, including base substitutions, insertion and deletion alterations, copy number alterations, and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden. Clinical performance was established by comparing the F1CDx to previously approved tests.

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