HHS expands monkeypox testing capability to five commercial laboratory companies

HHS expands monkeypox testing capability to five commercial laboratory companies

This week, the Department of Health and Human Services (HHS), through the Centers for Disease Control and Prevention (CDC), began shipping tests for orthopoxvirus to five commercial laboratory companies, including the largest reference laboratories. of the nation, to rapidly increase monkeypox testing capacity and access to every community during the ongoing monkeypox epidemic. Companies include Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare.

These commercial labs will greatly expand testing capacity nationwide and make testing more affordable and accessible for patients and healthcare professionals. Healthcare professionals will be able to use these labs by early July, and testing capacity across these companies will be increased throughout the month. This development will facilitate increased testing, leverage the established relationships between clinics, hospitals and commercial laboratories, and support our ability to better understand the extent of the current monkeypox epidemic.

“All Americans should be concerned about monkeypox cases. Thankfully we have the tools right now to fight and treat cases in America, “said Secretary of Health and Human Services Xavier Becerra.” By drastically expanding the number of testing locations across the country, we are making it possible for anyone needs to be tested to do so. “

As of Tuesday, June 21, 142 cases of monkeypox have been reported in the United States in 24 states and Washington, DC. Since the first case was reported to the CDC on May 17, 2022, HHS has been working to increase testing capacity and accessibility. This expansion to commercial laboratories reflects the latest and most significant increase in capacity and accessibility, building on the capabilities already available within the public health laboratory (LRN) response network. CDC, in partnership with the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services, and the HHS Office of the Assistant Secretary for Preparation and Response, has also expanded capacity in the LRN. CDC has partnered with the LRN to increase the number of public health laboratories capable of testing in more than 67 laboratories in 48 states and the number of weekly tests available within the LRN to over 8,000 tests per week. In addition to making testing more affordable and accessible through commercial labs, CDC will continue to work with state and local health departments to make the LRN process more efficient and contact health professionals and their state and local partners to learn more about monkeypox. .

In June, the CDC updated and expanded the monkeypox case definition and continues to encourage healthcare professionals to consider testing all rashes with clinically suspected monkeypox. Healthcare professionals who see a patient with a rash that resembles monkeypox or that may be more characteristic of more common infections (eg, varicella zoster, shingles, or syphilis) should carefully evaluate the patient for smallpox. of the monkeys (see pictures and links) and the test must be considered. Anyone with risk factors for monkeypox and a new rash should seek treatment and testing.

Since the United States took over its first case, the FDA has partnered with commercial labs and manufacturers to make monkeypox tests more readily available to patients and providers who need them. The FDA is working closely with CDC to increase production of its FDA-approved test. The FDA is simultaneously exercising enforcement discretion with respect to CDC testing, which allows hospitals to develop their own high-quality laboratory tests beyond the current LRN. CDC has released its FDA-approved testing protocol that all interested laboratories can use to start testing for monkeypox. The FDA has also cleared the use of additional reagents and automation to increase the testing capacity of labs using the CDC test.

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