US to expand monkeypox testing in commercial labs as outbreak grows

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The Biden administration announced Wednesday that it is allowing commercial labs to conduct monkeypox testing in a bid to dramatically expand testing as the United States faces a record outbreak that experts say is much larger than the official tally of 156 cases.

The Centers for Disease Control and Prevention this week began shipping test kits to five commercial lab companies, allowing healthcare providers to order tests directly from labs in early July. The companies include Quest Diagnostics, Sonic Healthcare, Labcorp, Mayo Clinic Laboratories and Aegis Sciences.

“By dramatically increasing the number of testing sites across the country, we are making it possible for anyone who needs to be tested to do so,” Health and Human Services Secretary Xavier Becerra said in a press release.

Officials say the move could allow the country to perform tens of thousands of tests a week, rather than relying solely on a nationwide network of public labs that can perform more than 8,000 tests a week. But federal officials acknowledge they can do a lot more testing.

The United States went from about 10 tests a day in early June to 60 tests a day last week, a senior Biden administration official told The Washington Post.

“It’s a relative increase, but it’s not close to where we want to be,” said an administration official, who spoke on condition of anonymity in accordance with ground rules set by the administration. to answer questions about monkeypox response.

Some public health experts say failure to do more testing hampers the ability to identify the extent of the outbreak and contain it.

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Under the current system, clinicians must report suspected monkeypox infections to health department officials who decide whether the cases meet the criteria for testing at public labs. Critics say the process, which could involve calling public health hotlines and answering detailed questionnaires, can be slow and cumbersome, deterring doctors from ordering tests.

Monkeypox causes sores and rashes that can be confused with other illnesses such as herpes and syphilis. Health officials say recent patient symptoms have been different from previous outbreaks, including rashes concentrated around the genitals and with no associated fever.

To test for monkeypox, providers must send a swab of a skin rash to a public laboratory that can determine if the patient is infected with an orthopox virus, referring to the family of viruses that includes monkeypox. A positive result is presumed to be monkeypox because no other orthopox virus is known to be circulating in the United States and is sent to the CDC for confirmatory testing.

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Activists and public health experts who have pushed for expanded testing say the Biden administration should have facilitated testing at commercial labs weeks earlier, before the outbreak escalated.

The test used was developed by the CDC and cleared for use by the Food and Drug Administration.

Before making the test widely available to commercial labs, the CDC needed to update those clearances, establish agreements with the five labs, and ensure staff had personal protective equipment and vaccines to protect against the infection, according to a senior public health official who also spoke on condition of anonymity under Biden administration ground rules.

FDA officials have in recent weeks begun coordinating with companies that manufacture the components of monkeypox test kits to ramp up production, according to an agency official who spoke on condition of anonymity because they are not allowed to have their comments attributed to them.

With more than 3,000 cases of monkeypox reported in dozens of countries, the World Health Organization is meeting on Thursday to consider designating the outbreak a public health emergency of international concern.

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