This article has been updated with information about a Citizen Petition filed against FDA regulation of LDTs by the American Clinical Laboratory Association, and with quotes from Sherri Bale. Originally published June 4.

CHICAGO – Regulation of laboratory-developed tests may once again be at the forefront of the US Food and Drug Administration's agenda, according to statements made by Commissioner Margaret Hamburg during a plenary session at the American Society of Clinical Oncology's annual meeting.

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