The session pivoted on a September 2016 publication, "Use of FDA-Approved and Laboratory-Developed Tests in Advanced Non-Small Cell Lung Cancer: Results of a Retrospective Market Analysis" (here) [*]. The survey found 87% use of LDT EGFR tests and 50% use of LDT ALK tests. Test rates for EGFR and ALK were 95% and 84%, respectively, in adenocarcinomas, somewhat lower among all NSCLC. (Some recent guidelines suggest that due to ambiguity about diagnosing adenosquamous or some adenocarcinoma cases, all cases should be tested for these markers.) Testing for ROS1 was circa 30%; other markers were 5% or less.
Open access coverage of the Senate event was available at Bloomberg here or here, and at Medpage Today here.
Hold on to your hats: Dr. Shuren promoted FDA regulation for uniform quality controls, while adding that FDA regulation would not be excessively burdensome. Other panelists argued that FDA regulation was costly, burdensome, and unnecessary.
FOCR raised concerns there may be too much test variability and that holding all tests to the same regulatory standards and quality would lead to more assurance regarding reports.
Panelists include Jonathan Leff, Deerfield Institute, Mike Pellini, Foundation Medicine; Jeff Allen, FOCR; Andrea Ferris, LUNGevity; John Iafrate, MGH; and Jeff Shuren, Director of CDRH, FDA.
Other recent Hill testimony by FOCR is here (Senate HELP committee, September 20, 2016).
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[*] The researchers reached out by mail to about 8000 oncologists, of which about 250 completed an online survey for an honorarium; representing about 750 patients.
Cloud archive of FOCR October 13 webpage, here.
