Quest Diagnostics’ monkeypox test available nationwide 

Quest Diagnostics announced July 13 that its molecular diagnostic test for the monkeypox virus is now available nationwide (with pending approval in New York). The Secaucus-based company also said it has plans to launch the Centers for Disease Control and Prevention’s orthopoxvirus test in August. 

As of July 12, the CDC has reported 929 confirmed cases of monkeypox nationwide and 11 in New Jersey. With its new automated test, Quest expects to be able to perform about 30,000 monkeypox virus tests a week by the end of July. 

Quest’s dual-target real-time polymerase chain reaction (PCR) test aims to detect and differentiate the monkeypox virus (West African clade, which is the virus circulating in the current global outbreak) DNA from other non-variola orthopoxviruses, according to the announcement. 

Validated under federal regulations, the test uses swab specimens collected by health care providers from patients exhibiting symptoms, namely an acute generalized pustular or vesicular rash.  

Related: BD collaboration aims to expedite monkeypox testing. Click here for more.

The company emphasized that these test “results should not be used as the sole basis of treatment or other patient management decisions.” 

In addition, Quest is validating the orthopoxvirus test from the CDC with the goal to provide it as an additional testing option in the first half of August. Quest stated that the Department of Health and Human Services announced it was one of five labs the CDC selected to expand nationwide testing for the monkeypox virus using the CDC’s orthopoxvirus test. 

“We commend the HHS and CDC for spearheading public-private collaboration to mobilize response to the current monkeypox outbreak,” said Dr. Jay Wohlgemuth, Quest’s senior vice president, R&D, medical and chief medical officer, said in a statement. “Quest’s expertise in infectious disease testing, national scale and relationships with half the country’s physicians and health systems is a vital complement to the efforts of the CDC and other public health labs to combat the monkeypox outbreak in the United States.” 

Ruth Clements, Quest’s vice president and general manager, Infectious Disease, added that COVID-19 “demonstrated the importance of broad access to quality laboratory testing for emerging infectious diseases.”