MDx: A murky brew

The gaps and overlaps in the regulatory environment surrounding molecular diagnostics are becoming more glaring as more complicated genetic tests make their way to market. The regulatory setting now has been further clouded by a CDC-supported working group, which has concluded there is insufficient evidence to recommend for or against the use of tumor gene expression profiles to improve outcomes in breast cancer patients.

The recommendations, published this month by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group, fly in the face of both FDA approvals and the recommendations of medical societies...