The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the latest results from an ongoing survey that ADLM has been conducting to determine how the Food and Drug Administration’s (FDA’s) final laboratory developed tests rule will impact patient care.
The survey found that, under the FDA rule, individuals from rural and historically marginalized communities will have severely limited access to vital tests, which could lead to harmful and even life-threatening delays in diagnosis and treatment.
View the full survey results here: https://www.myadlm.org/lp/ldts-survey
On May 6, 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. Currently, this rule is set to be phased in over the next 4 years. ADLM has long advocated against a move of this sort, contending 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 results from ADLM’s latest survey of clinical labs confirm this fear. The survey asked labs across the U.S., if the new rule goes into effect, will they seek FDA authorization for their laboratory developed tests or will they discontinue them? Forty-eight percent of respondents (n=121) said that they would discontinue their tests. According to the FDA, there are approximately 12,000 laboratories qualified to perform laboratory developed tests in the U.S. (out of a total of more than 300,000 clinical labs), which means that nearly 6,000 will stop offering these critical tests.
As a follow-up question, the survey then asked labs, if they were to stop performing their laboratory developed tests, is there another laboratory within their state that would offer the discontinued tests? More than 60% of respondents (n=159) said that there is no alternative laboratory within their state that offers the laboratory developed tests that they perform. This means that FDA’s rule will create a significant hardship for many individuals — particularly among rural and historically marginalized communities — who do not have the means to travel to obtain access to the tests needed to diagnose and treat their conditions.
