More than a dozen medical groups have joined AACC in asking that the Clinical Laboratory Improvement Advisory Committee (CLIAC) conduct a public meeting to discuss the modernization of CLIA regulations for laboratory developed tests (LDTs).
In a letter sent to Reynolds Salerno, PhD, director of the Division of Laboratory Systems at the Centers for Disease Control and Prevention and the designated federal official for CLIAC, the groups note that at the April 2021 meeting, CLIAC laid the foundation for such a discussion when it reviewed the role of LDTs within the context of the COVID-19 pandemic. They recommend that the committee build upon that conversation by initiating a discussion on the broader use of LDTs and gathering information on how CLIA oversight can be updated to ensure that physicians, other healthcare professionals, and patients continue to have access to high-quality, accurate LDTs.
“Among the various topics that could be addressed are what constitutes an LDT, what patient risks are posed by LDTs, whether LDTs should be stratified based on risk, and whether clinical validity should be required and, if yes, how it should be demonstrated,” says the letter. “We hope that such a meeting will start to resolve the confusion and conflict surrounding this issue, lead to better patient care, and continue the process of modernizing CLIA.”
NIH RADx Initiative Funds Development of New COVID-19 Rapid Tests
The National Institutes of Health (NIH) Acceleration of Diagnostics (RADx) initiative has awarded $77.7 million to develop and manufacture 12 new rapid diagnostic tests for SARS-CoV-2, the virus that causes COVID-19.
The grants target the need for high-performance, low-cost home tests and point-of-care tests that can potentially detect multiple respiratory infections. These projects are part of the RADx Tech program, which involves an intensive “Shark Tank”-style assessment of concept viability conducted by a panel of technical, regulatory, and business experts. The awards support the development, validation, scale-up, and manufacturing of rapid tests.
The new awards are in addition to 33 that NIH previously disbursed through its technology development program. The RADx Tech program has resulted in 32 Food and Drug Administration emergency use authorizations (EUAs), including the first home test EUA. Companies supported by the RADx program that received an EUA have contributed more than 840 million tests to the U.S. market since fall of 2020.
NIMHD Provides More Than $200 Million for Research on Chronic Diseases
The National Institute on Minority Health and Health Disparities (NIMHD) has awarded funds to 11 research institutions to establish and support regional comprehensive research centers on the prevention, treatment, and management of comorbid chronic diseases that disproportionately affect populations with health disparities.
These Multiple Chronic Disease (MCD) Centers received grants totaling almost $205 million, including funds committed over a 5-year period that will facilitate research on chronic diseases, including obesity, diabetes, hypertension, coronary heart disease, congestive heart failure, chronic kidney disease, chronic liver disease, stroke, and certain cancers.
Research projects from each MCD Center are expected to address determinants of health at two or more levels of influence—individual, interpersonal/organizational, community, and societal. In addition, interventions may address one or more of the following: prevention of chronic diseases by addressing risk factors and early stages of a condition; increasing access to or quality of healthcare
to detect and treat chronic diseases; enhancement of treatment quality; and self-management to manage chronic diseases and improve quality of life.
In addition, a pilot project program provides research opportunities for post-doctoral fellows, early-career faculty, or other early-stage investigators, including those from backgrounds underrepresented in the biomedical research workforce.
To coordinate activities across all the MCD Centers, NIMHD has also awarded $4.5 million and committed $18 million more over a 5-year period to establish a Research Coordinating Center.