Association for Diagnostics & Laboratory Medicine (formerly AACC) survey finds that FDA's final laboratory developed tests rule will hinder patient care for underserved communities

WASHINGTON, Sept. 5, 2024 /PRNewswire/ -- Today, 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, which is a deeply concerning finding. 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.

"Given the serious negative impact that the FDA's rule will have on underserved patient groups, ADLM urges lawmakers to rescind it," said ADLM President Dr. Anthony Killeen. "Concurrently, we encourage Congress to review and update CMS standards pertaining to laboratory developed tests. An overwhelming majority of labs surveyed — eighty-nine percent — stated that, if additional oversight of laboratory developed tests is needed, this oversight should be provided by CMS. This is a clear signal that enhanced CMS oversight is a better solution to this important issue, and we look forward to working with policymakers to make it a reality."

About laboratory developed tests

A laboratory developed test is a new or significantly modified test that is developed, validated, and used within a single clinical laboratory in response to a specific patient care need. Most laboratory developed tests are created because there is not already a Food and Drug Administration-approved test available, and they are often used to diagnose rare conditions, such as inherited genetic disorders. These tests are typically not advertised or sold as kits to other testing facilities.

The only labs that are allowed to perform laboratory developed tests are those that are considered high-complexity labs under the Clinical Laboratory Improvement Amendments, which are administered by the Centers for Medicare & Medicaid Services (CMS). These high-complexity labs are subject to rigorous oversight under CMS, and they are routinely inspected to ensure that they provide highly accurate testing.

About the Association for Diagnostics & Laboratory Medicine (ADLM)

Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.

Contact:
Christine DeLong
ADLM
Associate Director, Communications & PR
(p) 202.835.8722
[email protected]

Molly Polen
ADLM
Senior Director, Communications & PR
(p) 202.420.7612
(c) 703.598.0472
[email protected]

SOURCE Association for Diagnostics & Laboratory Medicine (ADLM)