Roche’s high-throughput test for the detection of monkeypox virus (MPXV) – cobas MPXV – has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA), the company announced.
The real-time polymerase chain reaction (PCR) test will detect DNA from MPXV in lesion swabs collected from individuals suspected of infection by their healthcare provider.
The tests will be conducted on Roche’s 6800/8800 cobas systems, which can also detect HIV, as well as hepatitis B and C viruses.
Testing will be limited to laboratories that meet the requirements to perform moderate or high complexity tests, the FDA outlined in a statement.
Roche’s test is now the first MPXV test to be granted EUA following evaluation in actual patient samples rather than samples formulated in the laboratory alone.
The test targets two different regions of the MPXV genome, Roche explained in a statement, which are both less prone to mutations than other parts of the genome.
This dual-target approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions, the company said.
MPXV is a viral zoonosis – a virus transmitted to humans from animals – with symptoms similar to those seen in the past in smallpox patients, although it is clinically less severe.
Like many viruses, MPXV cannot be conclusively diagnosed by symptoms alone as many of its symptoms closely resemble those of other rash-producing illnesses such as chickenpox, measles and bacterial skin infections.
Approximately 80,000 cases of MPXV have been reported in nearly 100 countries since the outbreak started earlier this year, however the number of cases has reportedly declined from the peak in August.
Despite the decline, the disease continues to be classed as a public health emergency by the World Health Organization, as well as the US, which has seen 28,000 cases reported this year, including two deaths.
Thomas Schinecker, chief executive officer of Roche Diagnostics, said: “When multiple clusters of MPXV 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.”