Roche: authorization in the United States of a screening test for monkeypox

The US Medicines Agency has given the green light to a Roche test for the detection of monkeypox, announced Wednesday the Swiss group at the head of a major division of diagnostic tools.

The authorization was given by the Food & Drug Administration (FDA) as part of an emergency procedure which makes it possible to accelerate the marketing of drugs or diagnostic tools, Roche said in a press release.

The Swiss group, which had quickly developed screening tests for COVID-19 at the start of the pandemic, was among the first to develop a test for monkeypox. Its test targets two different regions of the virus genome that are least likely to mutate so that it can continue to detect it if it were to evolve, specifies the Swiss group.

It is intended for use on its Cobas 6800/8800 machines, which are widely available in analytical laboratories and hospitals, which deliver results in three and a half hours, according to the release.

Her testing helps to prevent patients from being subjected to unnecessary testing or isolation that is not necessary and to ensure that they receive the appropriate treatments as quickly as possible, adds Roche, who points out that the symptoms alone are not enough to diagnose the virus.

World number one in oncology, Roche has a large division specializing in diagnostics, the weight of which has increased significantly since the COVID-19 pandemic with the demand for coronavirus screening tests.

Over the first nine months of 2022, this division, which also provides cancer diagnostics or diabetes monitoring tools, generated sales of 13.8 billion Swiss francs (14 billion euros), i.e. nearly 30% of group sales.