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FDA proposal on new medical test regulations faces opposition

Some New Mexico residents may have heard of FDA plans to begin regulating laboratory-developed tests just as they already regulate diagnostic tests developed by laboratory manufacturers. These types of tests may range from routine tests for sexually transmitted diseases to tests for certain genetic markers that suggest a cancer risk. The proposal is meeting with mixed responses from industry groups.

The American Hospital Association, the American Clinical Laboratory Association and the American Medical Association oppose the regulation. These groups have mounted various arguments against the regulation including concerns about patient access and cost as well as questions about whether the FDA has the authority for such regulation. Supporters of the regulation point out that some tests have returned inaccurate results, and those results have had serious medical consequences for some women. For example, a test for ovarian cancer that was eventually taken off the market resulted in a number of women needlessly having their ovaries removed due to these inaccuracies.

There is a concern that faulty tests may also result in a failure to diagnose a condition. On the other hand, opponents of the regulation argue that this may not be the best approach to fixing any existing problems because it may not necessarily guarantee a better quality of tests.

Individuals who have suffered from a delayed diagnosis or a failure to diagnose an illness in a time as a result of faulty laboratory tests may wish to consult an attorney. Medical malpractice may be the fault of a medical professional, a test manufacturer or some combination of the two. Because a missed or delayed diagnosis can significantly affect an individual's prognosis and the course of an individual's health care, a lawsuit against the responsible party or parties may be in order.

Source: Modern Healthcare, "Proposed regulation of lab tests draws mixed reviews at workshop", Jaimy Lee, Jan. 9, 2015

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