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- HHS Creates Interagency Group to Coordinate Efforts on COVID-19 Variants
On March 22, the CAP participated in the Centers for Disease Control and Prevent (CDC) Laboratory Outreach Communication System meeting. The CAP was represented by Council on Government and Professional Affairs Chair Jonathan Myles, MD, FCAP, who engaged on the following issues:
- The Department of Health and Human Services (HHS) established a SARS-CoV-2 Interagency Group to improve coordination among the CDC), National Institutes of Health (NIH), Food and Drug Administration, Biomedical Advanced Research and Development Authority (BARDA), and Department of Defense (DoD). This interagency group will be focused on the rapid characterization of emerging variants and actively monitors their potential impact on critical SARS-CoV-2 countermeasures, including vaccines, therapeutics, and diagnostics. Each variant class includes possible attributes of lower classes; variants status make escalate or deescalate based on scientific evidence. The categories are variants of interest, variants of concern, and variants of high-consequence. Currently, most of the variants being monitored by the CDC fall into variants of interests (New York and Brazil) while the remainder of the variants fall into the area of concern (California, South Africa, United Kingdom). The CDC provide data at the federal and state levels for each variant types found in the US.
- Representatives of the University of Illinois provided results from longitudinal testing study using antigen, RT-PCR, and culture.
- A CMS official provided an update on the revised CLIA program FAQs which allows laboratories performing and reporting genomic sequencing results to public health laboratories can do so without following CLIA regulations. However, if the laboratory reports sequencing results to patients, they must comply with CLIA regulations.
The FDA’s Tim Stenzel answered questions provided about FDA emergency use authorizations, variant impact testing performance, and regulatory requirements for direct to consumer testing versus home testing. The FDA continues to update its FAQs and will provide timely communications on variants impact on testing performance as more data becomes available.