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FDA Approves Foundation Medicine’s FoundationOne CDx, The First Pan-Tumour Comprehensive Genomic Profiling Assay Incorporating A Broad Range Of Companion Diagnostics

(Roche) Dec 4, 2017 - Roche announced today that the US Food and Drug Administration (FDA) has approved FoundationOne CDx™, Foundation Medicine’s comprehensive companion diagnostic assay for personalised oncology care.

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H. Jack West, MD (Posted: December 04, 2017)

quotesOn balance, I think this is an advance, as I believe that the lack of certainty about coverage is a significant barrier in getting NGS testing. For cancers like lung cancer, where there are already multiple molecular markers that can be tested individually or through NGS with a savings of limited tissue and potentially cost, there is a clear advantage to efficiency of broader testing. It's less clear that NGS is beneficial for a cancer for which there are not several previously identified markers to evaluate for. Though we might have some concern about mass scaling of a test costing several thousand dollars per test when there are no data demonstrating that this improves patient outcomes, I think there is more potential for harm based on poor decisions resulting from testing. Specifically, some clinicians may impart too much optimism on a treatment recommended based only on preclinical data and a theoretical benefit. These NGS reports include a wide range of possibly beneficial treatments, but that long tail, in order to justify the cost of the test, very often includes treatments of unclear if not frankly dubious benefit. There is the potential for net harm from the suggested targeted therapies, especially if oncologists and patients discard treatment options that are not individualized and therefore less sexy, but they still have well-established efficacy across broad populations. And there is definitely reason to be concerned that the costs of care will rise significantly because many oncologists will have too low a threshold to administer everolimus, at a cost of more than $10,000/month for every tenuously recommended mutation that could be associated with benefit. Whether broad molecular testing provides a quantum leap in efficacy of treatment or only its cost will depend on how wisely oncologists use the data that will pour in from this testing.quotes

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