The International Association for the Study of Lung Cancer is holding its 18th World Conference this week in Japan. Foundation Medicine has an abstract, available open access online, for a "universal combination diagnostic platform developed and performed in compliance with FDA 21 CFR 820" that interrogates 324 genes. The authors write, the test "is anticipated initially to have 8 CDx indications."
Whether this matches exactly what comes out of the FDA's approval process...is up to the FDA. As of September 2017, CMS has said that the FMI test is in parallel review for FDA approval and a CMS national coverage decision and that the results will be public soon (
here).
The FMI abstract is online
here. (At the conference link, click "plus signs" to see the full text.)
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