The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has expressed strong disagreement with the recent decision by the Food and Drug Administration (FDA) to issue a final rule subjecting laboratory developed tests to additional FDA authority, in addition to their current regulation under the Centers for Medicare & Medicaid Services (CMS).
While ADLM acknowledges the need to modernize standards for laboratory developed tests, they believe that the best approach is through a collaborative dialogue involving all stakeholders, including CMS and expert lab directors. By engaging in a broader discussion, thoughtful and sensible updates to regulations can be crafted to ensure patient safety while safeguarding access to essential tests.
The FDA’s rule, if implemented, could potentially limit patient access to laboratory developed tests. One provision of concern is the gradual phaseout of the agency’s enforcement discretion approach over a period of 4 years. This timeline is viewed as unrealistic, considering the FDA’s current capacity and the need to hire additional staff. The resulting delays in FDA authorization for laboratory developed tests would ultimately hinder patients from receiving timely diagnoses and care.
Another issue raised by ADLM is the proposal to grandfather in laboratory developed tests performed prior to the rule’s issuance. While the intent is to allow continued access to these tests, ADLM fears unintended consequences such as stifling innovation. The provision may discourage labs from modifying or replacing grandfathered tests with newer and improved testing services, as the new tests would then be subject to additional oversight.
ADLM strongly urges the FDA to engage in a true collaborative discussion with the laboratory community, including the Clinical Laboratory Improvement Advisory Committee (CLIAC). CLIAC’s diverse membership offers a suitable venue to address changes to current laboratory standards and work towards updating the regulation of laboratory developed tests in a way that enhances patient care.
For further insights on this issue, Dr. Octavia Peck Palmer, President of ADLM, is available for interviews. Please contact Molly Polen, ADLM Senior Director of Communications & PR, at [email protected] or 202-420-7612.
About the Association for Diagnostics & Laboratory Medicine (ADLM)
ADLM, dedicated to improving health through laboratory medicine, is a global organization comprising over 70,000 professionals in clinical laboratory science. Its membership includes clinical laboratory professionals, physicians, research scientists, and business leaders working across various disciplines within laboratory science. Since its establishment in 1948, ADLM has actively promoted scientific collaboration, knowledge sharing, expertise development, and innovation within the field.
For more information, visit ADLM’s official website at www.myadlm.org.
Media Contacts:
Christine DeLong
ADLM Associate Director, Communications & PR
Email: [email protected]
Phone: 202.835.8722
Molly Polen
ADLM Senior Director, Communications & PR
Email: [email protected]
Phone: 202.420.7612
Cell: 703.598.0472
New Laboratory Developed Test Regulations Seek Collaborative Dialogue for Patient Safety and Access
The recent decision by the Food and Drug Administration (FDA) to impose additional regulations on laboratory developed tests has been met with strong disagreement from the Association for Diagnostics & Laboratory Medicine (ADLM). While ADLM acknowledges the need to modernize standards for these tests, they believe that a collaborative dialogue involving all stakeholders, including CMS and expert lab directors, is the best approach for crafting sensible updates that ensure patient safety while maintaining access to essential tests.
One of the primary concerns raised by ADLM is the potential limitations on patient access to laboratory developed tests if the FDA’s rule is implemented. Of particular concern is the gradual phaseout of the agency’s enforcement discretion approach over a period of four years. ADLM argues that this timeline is unrealistic, considering the FDA’s current capacity and the need to hire additional staff. Delays in FDA authorization for these tests could ultimately prevent patients from receiving timely diagnoses and care.
Another issue highlighted by ADLM is the proposal to grandfather in laboratory developed tests performed prior to the rule’s issuance. While this provision intends to allow continued access to these tests, ADLM is concerned about unintended consequences, such as stifling innovation. The fear is that labs may become reluctant to modify or replace grandfathered tests with newer and improved testing services, as the new tests would then be subject to additional oversight.
ADLM strongly urges the FDA to engage in a true collaborative discussion with the laboratory community, including the Clinical Laboratory Improvement Advisory Committee (CLIAC). They believe that CLIAC’s diverse membership offers a suitable venue for addressing changes to current laboratory standards and working towards updated regulations that enhance patient care.
Current Market Trends:
In the field of laboratory developed tests, one of the current market trends is an increasing demand for personalized medicine. This trend is driven by advancements in genomics and molecular diagnostics, allowing for more targeted and precise diagnoses and treatment plans. Laboratory developed tests play a crucial role in providing the necessary diagnostic information for personalized medicine.
Forecasts:
The laboratory developed test market is projected to grow steadily in the coming years. According to a report by Grand View Research, the global laboratory developed test market is expected to reach $13.6 billion by 2025, with a compound annual growth rate (CAGR) of 8.9% from 2018 to 2025. Factors contributing to this growth include the rising prevalence of chronic diseases, technological advancements in diagnostic techniques, and the increasing demand for accurate and timely diagnostic tests.
Key Challenges and Controversies:
One of the key challenges associated with laboratory developed tests is the need for regulatory oversight. The FDA’s decision to subject these tests to additional regulations has sparked controversy and raised concerns about the impact on patient access and innovation. Balancing patient safety with the ability to rapidly develop and implement new tests is a challenge that regulators and stakeholders must address.
Advantages:
Laboratory developed tests offer several advantages over commercially manufactured diagnostics. They can be developed and implemented more quickly, allowing for faster access to new tests that address emerging health challenges. Additionally, they can be tailored to specific patient populations, providing more personalized and accurate results. Laboratory developed tests also foster innovation and encourage collaboration within the laboratory community.
Disadvantages:
One of the disadvantages of laboratory developed tests is the variability in quality and consistency. Unlike commercially manufactured diagnostics, laboratory developed tests may vary in performance and reliability between different laboratories. Ensuring standardized quality across all labs is a challenge that requires proper oversight and regulation.
For further insights on this issue, Dr. Octavia Peck Palmer, President of ADLM, is available for interviews. Please contact Molly Polen, ADLM Senior Director of Communications & PR, at [email protected] or 202-420-7612.
For more information about the Association for Diagnostics & Laboratory Medicine (ADLM), visit their official website at www.myadlm.org.
Media Contacts:
Christine DeLong
ADLM Associate Director, Communications & PR
Email: [email protected]
Phone: 202.835.8722
Molly Polen
ADLM Senior Director, Communications & PR
Email: [email protected]
Phone: 202.420.7612
Cell: 703.598.0472