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Impact of proposed law would increase regulatory oversight of certain diagnostic tests Legislation currently under consideration in the U.S. Congress would increase regulatory oversight of certain diagnostic tests, and a new study by researchers at Massachusetts General Hospital (MGH) and colleagues from several other institutions demonstrates that its potential impact will depend on key details in the bill s final language. This study, published in JCO Oncology Practice, offers the first evidence-based analysis of how new rules proposed for the regulation of laboratory-developed tests (LDTs) could affect health care costs in the United States. The idea of having more oversight of LDTs is justified. But our results show that it s very important to align the language in this new law with the intent of what it s trying to accomplish.

United statesJochen lennerzJeff allenRichard huangEmily hendersonUs congressDrug administrationFriends of cancer researchMassachusetts general hospitalStudy senior authorMedical directorIntegrated diagnosticsMassachusetts generalVerifying accurateCancer researchCancer treatment