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

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...