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FDA seeks greater oversight of unvalidated, unreliable diagnostic tests

On Behalf of | Jan 1, 2019 | Articles

The FDA is proposing stricter oversight of a subset of diagnostic tests that may cause harmful diagnostic errors due to poor premarket review and testing.

The U.S. Food and Drug Administration is reportedly pursuing greater authority to regulate a group of diagnostic tests that can be dangerously inaccurate or unreliable. As Fortune explains, laboratory-developed tests, which are produced and used within one lab, have traditionally escaped close FDA scrutiny. However, after a review of the harmful effects that these tests can have on patients, the FDA is proposing greater oversight, which could offer many benefits for people in Atlanta.

Problematic diagnostic tests

The regulation of LDTs used to be more relaxed because these tests were designed to diagnose relatively rare diseases, so they weren’t very widely used. Now, however, these tests have become more complex even as they have started focusing on common conditions, such as heart disease and cancers. As a result, incorrect or missed diagnoses resulting from these tests have the potential to affect hundreds of thousands of patients.

In late 2015, the FDA released a report that featured 20 case studies of problematic and potentially dangerous LDTs. Due to lower regulatory standards, many of these tests exhibited the following flaws:

  • Misleading or unsubstantiated claims – some tests featured manufacturer claims that trials and other data didn’t support.
  • Lack of premarket review or evidence of effectiveness – the efficacy of other LDTs wasn’t confirmed before the tests were introduced to the public.
  • Insufficient product instructions or warnings – many tests didn’t adequately advise physicians or patients on evaluating the test results or assessing the need for follow-up testing.
  • Lack of adverse event reporting – serious injuries and deaths resulting from unreliable LDTs haven’t been tracked, which could impede regulation and expose patients to tests with known problems.

The report discusses 20 case studies in which these shortcomings caused harm to patients. In some cases, patients underwent needless and potentially dangerous procedures as a result of incorrect diagnoses. For example, multiple ovarian cancer tests were found to produce false positives, causing women to undergo unnecessary ovary removal surgeries. In other cases, wrong or missed diagnoses caused patients to miss out on needed treatment. For example, sensitivity issues with one test reportedly resulted in missed breast cancer diagnoses.

Addressing harmful diagnostic mistakes

Given these issues, the FDA is proposing to complete more intensive premarket review of these products. This could help protect consumers from unreliable tests and unnecessary adverse outcomes. However, as The New York Times notes, the proposed changes may meet with opposition, as critics believe they may hinder innovation and result in over-regulation. Sadly, until these changes are made, diagnostic errors resulting from these medical tests may harm many patients.

If a physician makes an inaccurate diagnosis after using an unreliable test and ignoring other signs that support a different diagnosis, the victim may have legal recourse. However, under Georgia law, showing that a misdiagnosis represents malpractice can be challenging. Therefore, anyone who has suffered harm due to a diagnostic error should consider consulting with an attorney at the Hilley & Frieder, P.C., about the situation and potential legal remedies.