A report to Congress recently highlighted the number and extent of inaccurate medical tests that are not sufficiently regulated by the FDA. As a result of the inaccuracies, some people have life-threatening diseases that go undiagnosed or treated, and others undergo risky and expensive care for erroneous diagnoses.

The federal government is now seeking new regulatory powers over tests that were developed in private laboratories. Such testing is currently subject to few federally-mandated standards. The report to Congress outlined 20 case studies, half of which related to tests to diagnose and treat cancers. The FDA citers a blood test to help detect ovarian cancer that was not effective, but was used anyway. False-positive results have led to “unnecessary surgery to remove healthy ovaries.”

Other testing caused mothers to believe their fetuses had abnormalities which then led abortions. Some of the tests are intended to measure a genetic variant that may increase the risks of heart disease. As a result of false positives, many people were needlessly treated with statins to lower cholesterol, at a cost estimated to exceed $2 billion dollars.

Apart from needless suffering from test errors, the cost of the testing, and the cost of treating diseases that may not be present, is a threat to the government’s efforts to tailor treatments to specific genetic characteristics of individual patients. Even some Republican legislators, who generally favor a smaller government that does less regulating, are concluding that this gap in regulation has meant higher medical costs and greater human suffering. As one congressman said, “the volume and complexity of these tests have grown exponentially and federal standards may be needed.” Not surprisingly, the medical device manufacturers are opposing the new laws, and argue that more regulation would stifle medical innovation or even lead to federal regulation of the practice of medicine.

A consultant to drug and device companies, however, has said: “There will be more regulation, and it need not stunt innovations. The right regulation would separate good from bad tests and encourage use of the better ones.”