Pharmaceutical & Life Sciences News

Lab-Developed Testing Bill Still on the Table: Rep. Bucshon

July 25, 2018, 7:40 PM

Lawmakers are still working on a bill to oversee sophisticated medical screening tests without causing double regulation or stifling innovation, Rep. Larry Bucshon (R-Ind.) said.

Bucshon told Bloomberg Law on July 25 that he and Rep. Diana DeGette (D-Colo.) are meeting this week with staff from the Food and Drug Administration as well as the Centers for Medicare & Medicaid Services on a draft bill they released more than a year ago for laboratory-developed tests (LDTs). An LDT is “a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory,” according to the FDA’s...

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