U.S. to expand monkeypox testing at commercial labs as outbreak grows

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The Biden administration announced Wednesday it is authorizing commercial laboratories to conduct monkeypox tests in an attempt to dramatically expand testing as the United States confronts a record outbreak that experts fear is far larger than the official count of 156 cases.

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

“By dramatically expanding the number of testing locations throughout 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 news release.

Officials say the move could allow the nation to conduct tens of thousands of tests a week, rather than solely relying on a national network of public labs that can conduct more than 8,000 tests a week. But federal officials acknowledge they can be doing far more testing.

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

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

Some public health experts say the failure to conduct more tests 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 criteria to undergo testing at public labs. Critics say the process, which could involve calling public health hotlines and answering extensive questionnaires, can be slow and cumbersome, dissuading doctors from seeking tests.

Monkeypox causes lesions and rashes that can be confused with other illnesses such as herpes and syphilis. Health officials say recent patient symptoms have been different than in past outbreaks, including rashes concentrated around the genitals and without an associated fever.

To test for monkeypox, providers must send a swab from a rash to a public lab that can identify whether the patient is infected by an orthopox virus, referring to the family of viruses that includes monkeypox. A positive result is presumed to be monkeypox because no other orthopox viruses are 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 sooner, before the outbreak could worsen.

The test being 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 personnel had personal protective equipment and vaccinations to protect against infection, according to a senior public health official who also spoke on the condition of anonymity under the Biden administration’s ground rules.

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

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

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