Roche Obtains FDA Clearance for Monkeypox Test on High-Throughput MDx System

Roche announced on Wednesday that it has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for its Cobas MPXV test on its high-throughput Cobas 6800/8800 systems.

The real-time polymerase chain reaction (PCR) test for the qualitative detection of monkeypox virus (MPXV) DNA in lesion swabs is collected from persons with suspected monkeypox infection by their provider Health care.

The Cobas MPXV test targets two different regions of the MPXV genome that are both less prone to mutations than other parts of the genome, Roche said, adding that the dual-target approach ensures that Cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions.

Like many viruses, monkeypox cannot be conclusively diagnosed by symptoms alone. This is because many symptoms of monkeypox closely resemble those of other rash-causing illnesses such as chickenpox, measles, bacterial skin infections, and even hives or allergies.

“To meet the testing needs and workflow requirements of laboratories as well as to expand access to safe and reliable diagnostic solutions, we have developed the Cobas MPXV on the fully automated Cobas 6800/8800 System and high throughput,” Thomas Schinecker, CEO of Roche Diagnostics, said in a statement.

The high throughput solution can help individuals get the right results quickly. This is important so that patients are not subjected to unnecessary additional testing or isolation and have access to appropriate treatment as soon as possible, Roche noted.