FDA Seeks Greater Oversight Of Potentially Unreliable Diagnostic Tests

The FDA is working to implement stricter regulation of laboratory-developed diagnostic tests to address issues with their accuracy and reliability.

The U.S. Food and Drug Administration is reportedly pursuing stricter oversight of a subset of diagnostic tests that may be dangerously inaccurate and unreliable. According to Fortune, the FDA has traditionally refrained from exercising its full regulatory authority over laboratory-developed diagnostic tests. However, a recent analysis suggests that this policy may endanger patients in Huntington and other areas by exposing them to questionable tests and erroneous results.

Unproven medical tests

As Fortune explains, laboratory-developed tests are diagnostic tests that are created and utilized within the same laboratory. In the past, regulation of these tests was fairly relaxed because the typical LDT was simple and tested for a rare disease. Now, however, these tests are widely used to diagnose a variety of common conditions. Furthermore, the tests have grown more complex, which increases the risk of incorrect results.

In late 2015, the FDA published a report detailing 20 case studies of LDTs that tested for a variety of conditions, including ovarian cancer, prostate cancer, cardiovascular disease, fibromyalgia and heavy metal poisoning. According to the report, each of the reviewed tests possessed a significant flaw that could potentially endanger patients, including the following:

  • False positive bias. Some tests diagnosed conditions that were not actually present, which may have exposed patients to medical treatments that were unnecessary or even dangerous.
  • Failure to detect an existing condition. Other tests tended to produce false negatives, which may have led to missed or delayed diagnoses and kept patients from receiving needed treatment.
  • Overall inaccuracy. Other tests suffered from sensitivity issues and yielded a mix of false positive and false negative results.

According to the report, still other tests used scientifically unproven techniques, such as detecting a condition that was never conclusively linked to the disease in question.

Protecting against misdiagnoses

Proponents of stricter regulation hold that it could help ensure that potential issues with these tests are detected before patients suffer adverse effects. In its report, the FDA notes that closer regulation could ensure that LDTs meet the claims of manufacturers and that the reliability of these tests is confirmed before they reach the market. Improved oversight could also promote better tracking of any adverse events, such as patient injuries and deaths, associated with these tests.

Unfortunately, until these changes are implemented, these tests may contribute to many misdiagnoses. Patients should understand that in these cases, legal recourse might be available. Filing a product liability claim might be an option if a test has design defects or inadequate labeling that introduces an unreasonable risk of harm to users. If a physician makes a diagnosis based on an LDT while ignoring clear signs that point to a different diagnosis, victims may have grounds for a malpractice claim.

In either case, victims of misdiagnoses may benefit from consulting with an attorney as soon as they learn of the error. An attorney may be able to help a victim review the circumstances of the misdiagnosis, determine which parties may be liable and seek appropriate recompense.