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FDA concludes unreliable diagnostic tests may harm countless people

A new FDA report reveals that laboratory-developed diagnostic tests, which are less strictly regulated than other tests, may produce countless misdiagnoses.

Diagnostic errors represent a more serious threat to patient safety than many people in West Des Moines may realize. One study published in the journal BMJ Quality & Safety estimates that each year, medical professionals in the U.S. misdiagnose 12 million people. Troublingly, as Forbes notes, this study only focused on diagnoses in outpatient facilities. With misdiagnoses made in emergency rooms and inpatient settings factored in, the overall rate of these errors is likely even higher.

In some cases, a misdiagnosis may not reasonably be avoidable. This is especially true when a condition is poorly understood or a medical professional is working with limited information. Unfortunately, a new report from the U.S. Food and Drug Administration suggests that many unnecessary misdiagnoses may occur due to the use of medical tests that are known to be unreliable or scientifically unvalidated.

Worrisome accuracy issues

The report focused on laboratory-developed tests, which are medical diagnostic tests that are created and analyzed within the same laboratory. These tests aren’t held up to the same level of regulatory scrutiny as other diagnostic tests, and as a result, many may not comply with FDA standards. The report, which drew its conclusions based on 20 case studies of laboratory-developed tests, notes that countless people may have suffered harm due to the following issues with these tests:

• Inaccurate assumptions – several of the reviewed tests diagnose a condition by detecting the presence of a specific biomarker. However, research hasn’t yet conclusively linked many of these biomarkers and conditions together, which may render the diagnosis inaccurate.

• Poor sensitivity – the FDA found that many of the tests exhibited sensitivity issues, which increase the risk of false positives or negatives even if a test is scientifically sound.

• Improper marketing – many companies also inaccurately portrayed the reliability or effectiveness of these questionable tests.

The incorrect or delayed diagnoses that can result from these tests may have various harmful impacts, according to the report. Some people may undergo unnecessary treatments, such as long-term medication use or surgical intervention, while others may not receive appropriate treatment in a timely manner.

Enforcement discretion

In light of these findings, the FDA is considering stricter regulation of laboratory-developed tests. Fortune explains that the FDA previously didn’t closely review these tests because the agency has “enforcement discretion.” Since the tests were usually simple and designed to detect rare conditions, strict regulation seemed unnecessary. Now, however, these tests are widely used to detect common conditions that affect thousands of people. The tests have also become more complex, which may increase the risk of errors.

The FDA is now reportedly developing a plan to ensure that laboratory-developed tests receive a thorough premarket review like other diagnostic tests. Unfortunately, this change may come too late for countless patients who have already suffered harm from diagnostic errors.

Misdiagnosis as malpractice

In cases when a misdiagnosis could reasonably have been avoided, victims may have grounds for filing a medical malpractice claim. For example, if a medical professional ignored signs that pointed to another diagnosis and used a questionable test as the primary basis for a diagnosis, this may represent a professional lapse.

Unfortunately, proving that a diagnostic error should not have reasonably occurred may be challenging. In Iowa, victims of medical malpractice must present evidence that a physician breached a professional standard of care, including testimony from a qualified medical expert. To improve the likelihood of meeting these strict criteria, victims may benefit from consulting with an attorney for advice and assistance during the claim process.

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