Tag Archives: Ldts

FDA “Stepping Up Its Plans” To Regulate Laboratory-Developed Tests

This will have significant implications for patients who have tests performed by companies/laboratories that bring to market to their own tests they have validated and market for clinical testing. FDA, while it has always reserve the right to do so, has largely not regulated laboratory-developed tests.  This appears to be changing with some support by clinical organizations. Further discussions with the FDA, companies, laboratories and clinical diagnostics organizations are going to be required to balance patient safety, quality assurance and access for patients to important tests that are coming to market.

Stat (11/18, Fong) reports in continuing coverage that the Food and Drug Administration “is stepping up its plans to regulate all medical laboratory testing,” as a report released by the agency this week found 20 examples of laboratory-developed tests that may have harmed patients. Dr. Peter Lurie, FDA associate commissioner for public health strategy, said in a blog post, “FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.”

Modern Healthcare (11/18, Dickson) reports that Lurie also said, “These tests may suggest that a patient doesn’t have a disease or condition, when in fact they do.” Dr. Patrick Conway, the chief medical officer of the Center for Medicaid and Medicare Services, the agency that currently has jurisdiction over the lab-developed tests, said, “The CMS does not have a scientific staff capable of determining whether a test is difficult to successfully carry out or likely to prove detrimental to a patient if carried out improperly.” Medical societies, including the American Society of Clinical Oncology, support FDA regulation of lab-developed tests. Fortune (11/18) and The Scientist (11/18, Vence) also covered the story.