Advocacy - Lab Advocate
On March 22nd, an ADLM-led coalition of 27 healthcare associations, providers, and IVD manufacturers sent a letter to key leaders of the House and Senate Labor, Health and Human Services (HHS), Education, and Related Agencies Appropriations subcommittees urging legislators to increase funding for the Centers for Disease Control & Prevention (CDC) to harmonize clinical lab tests in Fiscal Year (FY) 2025 budget. This boost in resources would further the agency’s critical work in improving a foundational component of patient care and public health management.
Clinical laboratory tests are at the heart of healthcare, guiding essential medical decisions. With the healthcare system evolving towards a more interconnected model, the accurate and consistent interpretation of laboratory data across various platforms and providers has become paramount. Harmonization addresses the challenge of varying test results across different methodologies for the same patient sample—an issue that complicates diagnosis, treatment, and monitoring. A harmonized test delivers consistent results irrespective of the testing method or location, ensures that patient care is based on accurate and universally applicable data.
The CDC’s harmonization efforts have made notable achievements that underscore the importance of continued financial support. To date, the agency has:
- Developed and distributed vital reference materials for clinical standardization, benefiting both U.S. and international laboratories and medical device manufacturers.
- Significantly expanded the number of harmonized biomarkers, enhancing the diagnosis and treatment of a range of diseases, from cardiovascular and diabetes to cancer and kidney diseases.
- Improved the accuracy of point-of-care testing devices, crucial for in-clinic and at-home management of chronic conditions like diabetes.
- Conducted method performance evaluations, issuing certificates that inform healthcare providers about the reliability of current tests.
ADLM will keep working diligently to help secure funding for the CDC's harmonization’s efforts.