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Let It Out

Five US senators have sent a letter to the White House Office of Management and Budget, asking the office to release a draft guidance developed by the Food and Drug Administration regarding the regulation of laboratory-developed tests, the Pathology Blawg reports.

According to the Hill, the five Democrat senators led by Massachusetts' Ed Markey argue that as LDTs have become more complex over the years, they need to be regulated.

"Because these more advanced LDTs are a staple of clinical decision-making and are being used to diagnose, high-risk, but relatively common diseases, it is imperative that they perform as they are expected," the senators say in the letter. Other signatories of the letter include, Richard Blumenthal (D-Conn.), Sherrod Brown (D-Ohio), Dick Durbin (D-Ill.), and Elizabeth Warren (D-Mass.).

The draft guidance was developed by FDA in response to the development of increasingly more complicated tests, and it was sent to OMB in 2010 for approval where it has languished, the Hill notes.

According to Pharmacogenomics Reporter, the FDA Commissioner Margaret Hamburg said at the 2013 American Society of Clinical Oncology's meeting that the regulation of LDTs was moving higher on the agency's agenda.

"The agency is working to make sure that the accuracy and clinical validity of high-risk tests are established before they come to the market," Hamburg said.

"Our intent in considering what to do about LDTs is to provide for safe and effective diagnostics while promoting innovation and patient access," she added.