Lab-developed tests (LDTs) are diagnostic tools widely used across health care to test blood, tissue or other samples for infectious diseases, genetic markers, or other biomarkers of many conditions. ...
Since lab-developed tests are not widely marketed, they have been in a regulatory “gray zone” with minimal FDA oversight for nearly 50 years. Last year, the FDA issued a final rule aimed at stronger regulation of these tests. However, on March 31, a Texas federal court ruled that the FDA had overstepped its authority and vacated the FDA’s final rule in its entirety.
Journalists investigating lab-developed tests and the implications of the court’s decision can find a wealth of stories by diving into the various uses of LDTs and how they have helped or harmed patients.
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