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Roche's CE-marked monkeypox screening test could give the company a significant market advantage.
August 18, 2022
By: Michael Barbella
Managing Editor
The in-vitro diagnostics (IVD) industry is better prepared to deal with Monkeypox, thanks to the COVID-19 pandemic. Heightened disease control protocols left over from the pandemic are leading to the development of new Monkeypox IVD devices as medical professionals and world leaders race to contain the outbreak, notes GlobalData. According to the World Health Organization, more than 2,000 individuals have been infected with Monkeypox in 42 non-endemic countries since January. “Although it has been reported that Monkeypox is not as infectious as COVID-19, the general public is wary of taking a more reserved approach in containing the outbreaks,” said Selena Yu, a medical analyst at GlobalData. “Many regions are vaccinating individuals who have come in close contact with infected patients and are asking those exposed to quarantine.” Some of the major market shareholders for nucleic acid amplification tests (NAATs), outside of COVID-19 tests, are Qiagen, Roche, Abbott, Danaher, and Hologic. Roche has already launched three research-only tests in May and Eurobio released a CE-mark monkeypox screening test that is available to use in hospitals in June. With more than 1,700 Roche cobas 6800/8800 systems installed in 2021, GlobalData predicts a large market share for Roche if the company develops a medical-use monkeypox test on this system, as many hospitals already have the cobas 6800/8800 for COVID-19 diagnosis. Additionally, on June 27, Cepheid, a subsidiary of Danaher, and BioGX announced it is developing a monkeypox PCR test on the Cepheid GeneXpert system. Since there are more than 40,000 GeneXpert systems globally, GlobalData expects Cepheid to quickly become a leader in monkeypox IVDs. “Researchers have said that serological test methods, like antigen and antibody detection, cannot distinguish between orthopox viruses. Therefore, companies with the facilities and research abilities to produce large volumes and develop highly sensitive and specific NAATs will gain large market shares as the Monkeypox IVD market expands,” Yu said.
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