The US Food and Drug Administration (FDA) has been dealing with a significant influx of complaints about the inaccuracy of clinical lab tests. Even though diagnostic testing is a crucial part of healthcare, and having the right information can mean the difference between successfully or unsuccessfully treating a serious medical condition, errors can happen at many stages of the testing process. These might include simple user errors such as improper test selection, sample preparation problems, or interpretation issues. But a new kind of problem is cropping up: some tests have not been shown to be unreliable, and are being sold as accurate tests for specific conditions when they are not.
"A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions," noted FDA Commissioner Robert Califf, MD.
To address these serious concerns, the FDA has announced that they will begin regulating clinical diagnostic tests for the first time. The public will have a few months to comment on these proposed changes.
Commonly used tests, such as those that diagnose strep throat, COVID-19, and some other conditions are already tested by the FDA before they are marketed for sale. But there are thousands of tools that known as "laboratory developed tests" (LDTs), which are often used to identify rare types of cancer, STDs, and some other conditions are often used at sophisticated labs and have no FDA oversight.
The FDA noted that these tests were once used in only limited ways for a small number of patients under specialty care. But that was in the 1970s and 1980s, and things have clearly changed.
Not only are clinics able to ship patient samples all over the country to many types of labs, LDTs have become more popular and are used to diagnose issues in many more patients. These tests often guide crucial decisions in healthcare, noted the FDA. They added that some of these tests are now marketed directly to consumers as well, which has been accompanied by an increase in inaccurate results.
Now, the FDA has serious concerns about whether patients would start, delay, or forgo treatments based on the results of these tests, which may not even be accurate. This could cause worsening illness or death, they added.
Oversight will now be gradually phased in because the agency does not want to cause serious disruptions in the current testing market. They are hopeful that not only will this reduce the inaccuracies in test results and false and misleading claims in advertising, but it will also reduce the number of unnecessary procedures used on patients.
Source: US Food & Drug Administration