FDA wants to crack down on lab-developed tests: 3 things to know

The Food and Drug Administration aims next year to toughen up regulations on the lab-developed testing industry, according to an article in The Wall Street Journal.

Here are three things to know about the industry and why the FDA is cracking down on it.

1. Accuracy. The Wall Street Journal asserts that lab-developed testing, which it distinguishes from traditional lab testing, is the "Wild West" of medicine. Unlike traditional lab testing, in which companies sell diagnostic machines and test kits to labs across the country, lab-developed testing is a type of testing entirely developed and performed in a single laboratory. According to the report, these tests previously went unscrutinized by the FDA and often do not go through clinical trials, making many ineffective. This leads many patients to seek unnecessary treatment, though proponents have backed the tests and say they are accurate.  

2. Cost. According to the report, lab-developed tests can cost as much as $15,000 per test. Rochester, Minn.-based Mayo Medical Laboratories, part of Mayo Clinic, pulls in more than $600 million annually, according to the report. Inaccurate tests could not only be leading to unnecessary medical procedures, but could also be wasting millions of dollars annually, which is another facet of the FDA's objection.

3. Innovation. Proponents of the testing say the fairly unregulated environment allows for innovation — something that could be hindered by more FDA supervision. Many proponents of the testing say it saves lives. The report gives an example of a Mayo Clinic test that detects mutations in a group of genes called RAS. The test can help identify patients with metastatic colorectal cancer who benefit from a specific drug that has been shown to lengthen lives by 29 percent on average, according to the report. However, the FDA maintains that despite the potential benefits for patients, lab-developed testing presents great opportunity for patient harm due to insufficient evidence.

 

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