CDC to Jump-Start Test Harmonization Efforts With $2M in 2018 Funding

NEW YORK (360Dx) – After years of lobbying by the American Association for Clinical Chemistry and other laboratory industry associations, the Centers for Disease Control and Prevention has been awarded $2 million in federal funding to harmonize results of clinical lab tests.

The catch is, the money must be spent in the next six months. The $2 million awarded to CDC in the omnibus bill signed by President Trump last week is allocated for fiscal year 2018, which ends September 30. The CDC is aiming to start harmonization efforts as soon as it receives its fiscal year funding 2018 allocation, according to a CDC spokeswoman.

"They don't have much time and they have to hustle, and I get a sense that they are gearing up to do just that," said David Koch, chair of the AACC policy and external affairs committee, and director of clinical chemistry, toxicology, and POCT at Grady Memorial Hospital, as well as a professor of pathology and laboratory medicine at Emory University.

The $2 million in funding for 2018 will be used to advance harmonization effort for free testosterone, thyroid stimulating hormone, and estrogen, or estradiol. These tests were selected in part because CDC has already begun standardization work involving reference materials and reference methods, in relation to testosterone and estrogen, Koch said.

Thyroid stimulating hormone, or TSH, is a frontline test for thyroid disease and is often the first test ordered for patients suspected of having a thyroid disorder. Endocrine guidelines published by endocrine organizations are reliant upon TSH measurements, and harmonized test results could help guidelines become even more effective for clinicians, he noted.

Harmonization is a multistep process that involves not only producing reference methods and reference materials, but also working with vendors of different tests to encourage adoption of harmonized test results, which could involve recalibrating some tests to comply with harmonized standards, Koch noted.

"AACC and other laboratory organizations can play a rule in facilitating those discussions and getting all the manufacturers on board with harmonizing the results," Koch said. AACC has an advisory board made up of representatives of different test vendors, which enables the organization to communicate with vendors both as a group and individually, he noted.

The $2 million in 2018 funding comes after 17 lab industry organizations banded together last May to send a letter to the House Appropriations Committee requesting an initial $9.2 million in additional CDC funding for the harmonization project. In addition to AACC, signatories of the letter included 10 other industry associations, such as the American Clinical Laboratory Association, the College of American Pathologists, and American Medical Technologists; three labs – Quest Diagnostics, Laboratory Corporation of America, and ARUP Laboratories; and three lab test manufacturers – Roche Diagnostics, Siemens Healthcare Laboratory Diagnostics, and Thermo Fisher Scientific.

"Harmonized test results will ensure that clinical guidelines based on the results of laboratory tests lead to appropriate care by enhancing the reliability of screening to detect diseases early, by producing more accurate diagnoses, and by preventing treatment errors," the groups argued in the letter.

The CDC followed with a letter in June to US Rep. Kevin Yoder, R-Kan., a strong advocate of lab test harmonization efforts, outlining how the requested funding could be used.

"Were additional resources to become available, CDC could develop reference quality methods for additional, selected clinical tests, including those for free testosterone, free thyroid hormones, glucose, thyroid stimulating hormone, and troponin," Anne Schuchat, acting director of the CDC wrote. "CDC could use these methods to assign target levels to blood serum and reference materials, and provide these materials to private laboratories and manufacturers to improve the accuracy and precision of their measurements."

CDC's Division of Laboratory Sciences currently harmonizes tests for cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides, and has pilot programs for vitamin D, testosterone, and estradiol, according to a CDC spokeswoman.

"These programs currently reach over 1,000 laboratories and test manufacturers and provide the foundation for advancing harmonization of clinical laboratory results," the spokeswoman said.

For lab industry associations, test harmonization has been an advocacy issue for years. The AACC published a 25-page white paper on the topic in 2015, but began advocating for test harmonization long before that, Koch said. A standardization program for hemoglobin A1c begun in the 1990s and run by the NGSP (formerly known as the National Glycohemoglobin Standardization Program) has greatly improved the clinical usefulness of hemoglobin A1c testing for diagnosing diabetes, the 2015 white paper noted.

Moving forward, working with legislators to try to secure continued systematic funding for test harmonization will be a key priority for the AACC and other lab associations.

"Our primary role here will be to continue to advocate for this funding in future budgets," Koch said. "We hope that it will be a regular sustainable amount."

It is unclear yet how CDC will spend the $2 million in 2018, Koch said. The money could potentially be used to purchase additional instrumentation. It could also enable the agency to reallocate employees, or hire an additional person dedicated to this work. How long it takes to complete the process of harmonizing test results varies depending on the complexity of the situation, Koch noted.

"It is certainly expected that $2 million will move the progress along rather quickly, whereas it would not have moved along quickly at all without the $2 million," he said.