Source: modernhealthcare.comAuthor: Merrill Goozner The Food and Drug Administration's proposal to regulate the accuracy of laboratory-developed tests has drawn heated opposition from the laboratory testing industry, hospitals and most medical specialty societies. Only oncologists favor tighter oversight.It's not just cancer docs who should be concerned. We're entering a new era where there will be much more genetic testing. Higher standards are necessary. Since 1988, routine laboratory tests performed inside labs have come under the Clinical Laboratory Improvement Amendments, which has largely exempted them from FDA oversight. Only if a company sold test kits to hospitals or physician offices did the FDA regulate them as medical devices, with attendant performance and manufacturing standards.Until recently, this didn't present much of a problem. Most lab tests are fairly routine—testing blood for cholesterol, sugar or sodium, for instance. A robust industry dominated by large national companies like LabCorp, Quest Diagnostics and ARUP Laboratories provides a market-based solution for ensuring those tests are affordable and high quality. Hospitals and physician offices that conduct their own in-house tests benefit from the exemption, too. Some large institutions that operate their own labs save money because of their economies of scale. Major academic medical center labs operating under CLIA also play a leading role in developing new tests for rare or hard-to-treat conditions.But in recent years, there has been a proliferation of new tests based on genetic information that are being marketed by independent firms making claims that have not been validated by clinical trials or other scientific methods. They claim to show a person's propensity [...]