Test makers target monkeypox market as cases rise

Test tubes labeled “Monkeypox virus positive and negative” are seen in this illustration taken May 23, 2022. REUTERS/Dado Ruvic/Illustration/File Photo

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LONDON, June 3 (Reuters) – Diagnostics companies are racing to develop tests for monkeypox, hoping to tap into a new market as governments step up efforts to trace the world’s first major outbreak of the virus infection outside of Africa.

The rush began last month, much like early 2020 when companies rushed to manufacture kits to help diagnose COVID-19, creating a multi-billion dollar windfall for test makers.

But the demand for monkeypox tests will be a fraction of what it was for COVID, given that monkeypox is not as transmissible or as dangerous as COVID – it is usually spread through close contact and can cause flu-like symptoms and pus-filled skin lesions that usually go away on their own within a few weeks. Read more

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And unlike the sudden emergence of COVID, there are vaccines, treatments, and tests that can already help curb the spread of monkeypox. Read more

A new niche market could mitigate – but will not offset – the expected slowdown in sales of COVID diagnostics as the need for testing for the SARS-CoV-2 virus decreases and concerns about monkeypox increase, analysts say.

Roche (ROG.S), for example, made 1.9 billion Swiss francs ($2.0 billion) in sales of COVID tests in the first quarter, and Barclays analyst Emily Field estimates the tests will generate 3 billion Swiss francs in total for the company in 2022.

“It would be very difficult for monkeypox revenue to offset that in any meaningful way,” she said.

More than 550 confirmed cases of monkeypox have been reported from around 30 countries since early May. The majority were in Europe and were not linked to travel to Africa, where the virus is endemic. Public health authorities suspect some degree of community transmission. No deaths have been reported.

Still, the World Health Organization (WHO) has said it expects infections to rise as surveillance expands and its European official has warned the spread could accelerate as people gather for parties and festivals during the summer. Read more

This epidemic is large on the scale of monkeypox, but there is not yet a need for hundreds of thousands of tests, which was the case when COVID appeared, said Daniel Bausch, senior director, emerging threats and health security. world at FIND, the global alliance. for diagnosis.

“It’s not going to be the next COVID…so I don’t think the needs are huge. I’m not anticipating [test] supply is a problem.”

TEST, TEST

Some countries, including Switzerland and the Netherlands which have only reported a handful of cases, say they have sufficient testing capacity for monkeypox at the moment. Britain, where nearly 200 cases have been confirmed, is working to expand capacity.

Although researchers have previously had fragmented access to the chemicals and other materials needed to perform PCR tests for monkeypox, kits developed by companies such as Roche theoretically allow them to have everything they need in one place. place to process a sample in a laboratory.

Kits like the one from Roche have not been cleared by regulators for use as a medical diagnosis – however, they are only available for research purposes.

Meanwhile, more than a dozen listed Chinese companies, including Jiangsu Bioperfectus Technologies (688399.SS), claim to have added the European Union’s CE quality mark to their kits.

The scheme allows test manufacturers to certify themselves that they comply with EU regulations and can therefore be sold in the region. Read more

Broadly, there are two types of tests: PCR and antigen tests are designed to detect if someone is currently or very recently infected, while antibody tests show if someone has ever been infected.

Monkeypox virus is a member of the orthopoxvirus family which also includes smallpox and cowpox

PCR tests are the gold standard test for detecting monkeypox, according to the WHO, while the way antigen and antibody tests are designed make it less likely that a positive result is definitively indicative of monkeypox.

It is not known whether infected but symptomatic people can spread the virus, the WHO says, so it is not known whether precautionary testing of suspected cases is necessary.

However, as suspected cases are expected to self-isolate for up to 21 days, rapid antigen testing could be helpful, given that there is currently no smallpox virus disease that has spread widely through populations. , said Carlos Maluquer de Motes, who leads a research group studying the poxvirus. biology at the University of Surrey.

Most diagnostic manufacturers focus on PCR testing for monkeypox. A few others, including Tetracore Inc, are working on rapid antigen tests.

However, caution is advised.

“Virtually none of the kits, whether listed for research or not, have undergone extensive validation,” Bausch said. “It would be interesting to order all the tests that suddenly hit the market and see what you get.”

($1 = 0.9580 Swiss francs)

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Reporting by Natalie Grover in London; additional reporting by Ludwig Burger in Frankfurt, Roxanne Liu in China, Michael Shields in Zurich and Anthony Deutsch in Amsterdam; Twitter: @NatalieGrover; Editing by Matt Scuffham, Josephine Mason and Mark Potter

Our standards: The Thomson Reuters Trust Principles.