Lab Company That Touts Dual FDA/CMS Review Model For LDTs Allegedly Probed By Both Agencies

October 16, 2015 at 7:10 PM
A start-up lab test company that has pushed dual approval by FDA and CMS as a regulatory model for government oversight of laboratory developed tests is being audited by CMS and under fire by FDA for allegedly using unapproved medical devices, according to a press report. This alleged development comes after the company hired lobbyists to advocate its position on a need for strong FDA oversight of LDTs in addition to the historical oversight by CMS. A spokesperson for Theranos...

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