The high-throughput solution is said to help individuals suspected of the virus to avoid unnecessary isolation or additional testing, while facilitating early access to the appropriate treatment to those who test positive
Cobas MPXV is designed for use on the cobas 6800/8800 Systems. (Credit: F. Hoffmann-La Roche Ltd)
Swiss healthcare company Roche announced that the US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to its cobas MPXV for the detection of DNA from the monkeypox virus (MPXV).
Roche said that the test will be used on the cobas 6800/8800 Systems, which are also employed for detecting human immunodeficiency virus (HIV) and hepatitis B and C viruses.
According to the company, cobas MPXV is a real-time PCR for qualitatively detecting DNA from the monkeypox virus in lesion swabs taken from individuals who are suspected to have the virus.
The cobas MPXV is said to target two distinct areas of the MPXV genome that are less prone to mutations compared to other parts of the genome. This dual-target strategy can detect the virus even if one of the target regions mutates, said Roche.
Roche Diagnostics CEO Thomas Schinecker said: “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.
“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.”
Roche said that the high-throughput solution delivers the right results quickly and removes the need for unnecessary additional testing or isolation. It will also facilitate early access to the appropriate treatment.
The cobas 6800/8800 Systems are claimed to offer faster time-to-results, increased operating efficiency, and flexibility. It can produce up to 96 results in nearly three hours, said Roche.
Recently, the healthcare company received FDA approval for its VENTANA FOLR1 (FOLR1-2.1) RxDx assay to detect the folate receptor 1 protein.