Stacy Cline Amin spoke to BioCentury about the U.S. Department of Health and Human Services reversing a Trump administration’s policy on the regulation of laboratory developed tests (LDTs).
According to Stacy, legislation to clarify the Food & Drug Administration’s regulation of LDTs is needed. “It was not sustainable to have the state of uncertainty that existed before the pandemic, and it certainly does not seem sustainable now.”
“I would expect to see both the industry and the agency really focus on a legislative solution that will provide stability,” she added. “Certainty and stability is really important for a private industry if they are going to invest resources in a test.”