Foundation Medicine Inc., the America based healthcare and medical devices market giant, has recently won a simultaneous approval from the Center for Medicare and Medicaid Services and the U.S. Food and Drug Administration for a cancer gene therapy test. Reportedly, the test, dubbed as FoundationOne CDx, is capable of detecting cancer causing mutation in almost 324 genes. Sources further claim that under the Parallel Review Program, FoundationOne CDx is the second diagnostic test that has received a coordinated regulatory approval from two of the world’s top-notch organizations. As per expert opinions, FoundationOne CDx, may, in all likeliness, be the next disruptive trend in cancer gene therapy industry.
FoundationOne CDx mainly aims at lending a supportive hand to the recipients of the Federal Medicare program, so that the patient pool gets an open access to cutting-edge medical technologies, cite sources. Reportedly, prior to this, Foundation Medicine has made to the headlines with its patent-validated CGP (comprehensive genomic profile) test, FoundationOne. For the record, FoundationOne is the first ever comprehensive companion approach diagnostic test targeted for multiple types of cancer that had received the FDA approval.
Currently, there has been a wave of disagreements among cancer experts with regards to whether testing tumors for cancer affected mutations or companion diagnostics drugs targeting these mutations benefits patients or not. In response to this, FDA officials claim that FoundationOne CDx would eradicate the requirement of undergoing multiple biopsies for single-gene tests. Furthermore, the fact that the test has been jointly approved by the FDA and Center for Medicare and Medicaid Services, is one of the very important acquittals for Foundation Medicine’s product line in cancer gene therapy market.
Allegedly, the insurance coverage for this kind of companion diagnostics test, until now, has been a little backfooted, primarily influenced by the private insurers’ benefit of doubt regarding these tests due to lack of adequate clinical evidence. The approval however could prove to be one of the crucial precedents to bring companion diagnostics test under private insurance coverage, claim experts.