CDC needs increased funding to harmonize clinical lab testing

March 2024


BCHC signed onto a letter led by the Association for Diagnostics and Laboratory Medicine urging the House and Senate Appropriations Committee to finalize the FY 2025 Labor, Health and Human Services, Education and Related Agencies appropriations bill with increased funding for the Centers for Disease Control and Prevention to continue its efforts to harmonize the reporting of clinical laboratory test results.

Congress has supported CDC’s harmonization efforts over the past several years and the agency has responded by producing several breakthroughs. Increased funding enabled the CDC Clinical Standardization Programs to:

  • Produce and distribute reference/harmonization materials for clinical standardization programs, utilized by clinical laboratories and medical device manufacturers in the US and countries around the world, that improved the accuracy of chronic disease biomarker testing used in patient care and public health.
  • Substantially increase the number of harmonized biomarkers (from 10 in 2014 to 26 in 2022) used by physicians to diagnose and treat diseases such as cardiovascular disease, diabetes, certain cancers, blood pressure, bone disease, kidney disease, and developmental diseases.
  • Expand harmonization/standardization program activities by improving point-of-care-testing devices used in clinical and in-home settings, such as those used by individuals with diabetes, and engaging additional strategic partners, such as patient advocacy groups and payers, through outreach and education.
  • Increase the number of method performance evaluations of laboratories/manufacturers and issue more performance certificates that let manufacturers, physicians, and other healthcare providers know about the accuracy and reliability of tests currently in use.

To continue this advancement, we recommend that for FY 2025 the CDC be appropriated an additional $7.2 million for activities directed by its Environment Health Laboratory.

We believe this continued investment in CDC will lead to future cost savings and better health outcomes. 

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