On Jul. 13, 2022, Quest Diagnostics announced that it had announced the nationwide availability of the company’s lab-developed molecular diagnostic test to aid in the diagnosis of infection with the mpox virus, with plans to launch the CDC’s orthopoxvirus test in the first half of August.

The company’s novel dual-target real-time polymerase chain reaction (PCR) test is believed to be the first commercially available test developed and offered by a national laboratory provider to aid in the qualitative detection and differentiation of mpox virus (West African clade) DNA from other non-variola orthopoxviruses.

Developed by the company’s research and development team, the test was validated under CLIA federal regulations, and is now performed at the company’s advanced laboratory in San Juan Capistrano, Calif. The test uses swab specimens collected by healthcare providers, such as in physician offices and hospitals, from patients presenting with an acute generalized pustular or vesicular rash. Test results are intended to be used in conjunction with clinical observations and epidemiological risk factors, and results should not be used as the sole basis of treatment or other patient management decisions.

With the new automated test, Quest expects to be able to perform approximately 30,000 mpox virus tests a week by the end of July. Depending on demand, Quest can expand capacity for mpox testing across other advanced laboratories in its national network. 

In addition, Quest is currently validating the orthopoxvirus test from the Centers for Disease Control and Prevention (CDC) with the goal to provide it as an additional test option to physicians in the first half of August. On June 22, the Department of Health and Human Services announced Quest Diagnostics is one of five laboratories the CDC selected to expand nationwide test capacity for the mpox virus using the CDC’s orthopoxvirus test.