, /PRNewswire/ -- Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the results of a survey that ADLM conducted to determine how the Food and Drug Administration's (FDA's) final laboratory developed tests rule will impact patient access to essential tests. The survey found that, in spite of certain tests being exempt from the rule, it will still force many laboratories, particularly those in hospitals, to discontinue critical tests, including those needed to identify prescription and illegal drug use. On , the FDA published a final rule on laboratory developed test regulation that will place these tests under FDA oversight, in addition to the Centers for Medicare & Medicaid Services (CMS) oversight that they are already under.
ADLM has long contended that labs do not have the resources to meet the FDA's regulatory requirements on top of CMS', and that this duplicative regulation will push many labs to stop performing these essential tests. The FDA, on the other hand, has emphasized that the final rule exempts certain categories of laboratory developed tests from the agency's full review process, though exempt tests will still be subject to other regulatory requirements. These exempt tests include so-called grandfathered tests that were offered prior to the publication of the rule, as well as tests that fill an unmet need that no FDA authorized test addresses.
After the rule is phased in, which will happen over the course of 4 years, t.