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 to develop cancer or Alzheimer's disease. The FDA has approved several new cancer drugs aimed at specific genetic mutations, and simultaneously approved the companion diagnostics needed to identify those mutations.
When companies market tests that have not been scientifically validated, it can lead to unnecessary spending and poor outcomes. Five years ago the Journal of the American College of Cardiology published a study debunking claims that a widely used test produced by Celera Corp. (founded by human genome pioneer J. Craig Venter) was able to identify people with a specific genetic mutation who were more at risk for heart attacks and would be more likely to benefit from taking statins.
An accompanying editorial by Drs. Eric Topol and Samir Damani at the Scripps Research Institute warned that the “story should serve as a valuable reminder of the potential pitfalls present in prematurely adopting a genomic test without sufficient evidence.”
More recently, actor Michael Douglas' announcement that his bout with throat cancer had been caused by oral sex set off a marketing frenzy by HPV test manufacturers to dentists. They say the HPV test will aid in early detection and help prevent some of the 7,600 oral cancer deaths in the U.S. each year.
Given that only nine of 200 strains of HPV are associated with cancer and only one of the nine is associated with throat cancer, it would be nice to know if these tests identify the correct strain.
No one wants to see incumbent labs and test makers use tighter regulation to prevent competition. The presence of the BRCA1 and BRCA2 genes as risk factors for breast cancer has been well-validated by science. The U.S. Supreme Court's 2013 ruling that Myriad Genetics' patents on those genes were invalid opened the door to numerous companies offering the test at lower prices. Would a requirement that they validate tests before marketing them really have stopped those companies from entering this lucrative field?
The FDA doesn't have legislative authority to regulate in-house lab tests, a fact seized on by opponents of its draft guidance who know the current Congress will not pass new legislation. The American Clinical Laboratory Association, the industry's trade group, hired legal heavyweights Paul Clement, the Bush administration's solicitor general, and Laurence Tribe, Harvard's renowned constitutional law scholar, to guide the opposition.
A better course would be for opponents to work with the agency to come up with reasonable oversight standards. Medical practitioners and the public deserve protection from test purveyors making unproven claims.
