FDA Grants EUA to Roche's Real Time PCR Test for Monkeypox Virus

The FDA has granted an emergency use authorization (EUA) to Roche’s cobas monkeypox virus (MPXV) real time PCR test to use on the cobas 6800/8800 Systems for the detection of monkeypox. The test is used for the qualitative detection of DNA from MPXV in lesion swabs taken from those with suspected MPVX infection by their health care provider.

cobas MPXV targets 2 different regions of the MPXV genome that are less prone to mutations than other parts of the genome. The dual-targeting system allows the cobas MPXV test to detect the virus regardless of whether a mutation occurs in either of the target regions, according to Roche.

“When multiple clusters of monkeypox virus infection were initially reported in countries where the disease is not endemic, Roche was among the first companies to address virus concerns with test kits,” said Thomas Schinecker, CEO of Roche Diagnostics, in a press release. "In order to meet the testing needs and workflow demands of laboratories as well as expand access to safe and reliable diagnostic solutions, we developed the cobas MPXV on the fully automated and high-throughput cobas 6800/8800 system."

The cobas 6800/8800 Systems are able to produce results in 3 and a half hours, providing up to 96 results in approximately 3 hours with a total of 1440 results for the cobas 6800 System and 4128 results for the cobas 8800 System in 24 hours, according to Roche. The EUA for the high-throughput test will enable individuals to obtain quick test results to spare them from unnecessary additional testing or isolation. It will also enable patients to access the appropriate treatment as soon as possible.

The symptoms of MPVX include fever, chills, headaches, muscle aches, fatigue, swollen lymph nodes, and a painful rash typically presenting as raised bumps on the skin of the face, extremities, and genitals. The bumps typically fill with pus and fluid as the disease progresses and before they eventually ulcerate, scab and fall off. However, MPVX is not able to be conclusively diagnosed by symptoms alone because many of these symptoms are similar to other rash-producing illnesses, such as chickenpox, measles, bacterial skin infections, and even hives or allergies.

cobas MPXV is the first monkeypox test granted an EUA after an evaluation in actual patient samples instead of samples developed in a laboratory. The assay uses β-globin, a target found in human DNA, as an endogenous control to ensure specimen adequacy.

“Unlike the previously cleared assay, cobas MPXV detects monkeypox nucleic acids and the endogenous control in the same well, improving laboratory efficiency by effectively doubling the number of clinical samples a laboratory can assess on each plate and halving reagent needs per sample,” Roche said in a press release.

The test is only for use under the FDA’s EUA in laboratories that are certified under Clinical Laboratory Improvement Amendments meeting the requirements to perform high or moderate complexity tests. The cobas MPXV test is intended for use by qualified clinical laboratory personnel who are specifically trained on the techniques for real-time PCR and for use with the cobas 6800/8800 Systems.

Reference

Roche receives U.S. FDA Emergency Use Authorization for its high-throughput test to detect monkeypox virus. Roche. News release. November 16, 2022. https://www.roche.com/media/releases/med-cor-2022-11-16