publication date: Dec. 1, 2017
FDA approves Foundation Medicine’s genomic profiling test for all solid tumors; CMS proposes coverage
By Matthew Bin Han Ong
FDA has approved the FoundationOne CDx, the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.
The Centers for Medicare & Medicaid Services—at the same time—proposed coverage of the F1CDx, a laboratory-developed test sponsored by Foundation Medicine.
This is the second time the combined approval mechanism has been used. The first such approval was given to Cologuard, a stool DNA test sponsored by Exact Sciences Corp. (The Cancer Letter, March 28, 2014).
There are two other genomic tests approved by FDA. They are the Oncomine test for targeted therapies for non-small-cell lung cancer sponsored by Thermo Fisher Scientific.
Another FDA-approved next-generation sequencing test is Praxis Extended RAS Panel used to detect genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is sponsored by Illumina Inc.
Both these tests are approved for specific genes and tumor types, Neither Oncomine nor Praxis has gone through parallel review by CMS.
The just-approved F1CDx test is formally different from Foundation Medicine’s flagship FoundationOne test, … Continue reading FDA approves Foundation Medicine’s genomic profiling test for all solid tumors; CMS proposes coverage
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