New monkeypox testing kits in development - Medical Device Network

2022-09-17 01:07:53 By : Ms. carlen shu

Becton Dickinson’s partnership with CerTest Biotec is expected to aid in understanding the global spread of the monkeypox virus.

Becton Dickinson has partnered with CerTest Biotec to produce a molecular diagnostic test for the monkeypox virus. This new VIASURE Monkeypox CE/IVD test will be developed using the BD MAX open system reagent suite and validated on the BD MAX system.

The BD MAX system is an automated platform for nucleic acid extraction and real-time polymerase chain reaction (PCR) testing. It can provide results for up to 24 samples within three hours, making it an exceptionally efficient means of testing. The platform also offers a range of tests covering sexually transmitted infections, respiratory infections, gastrointestinal infections, healthcare-associated infections and women’s health diagnostics.

As of 8 June, there have been 1,285 confirmed cases of the monkeypox virus spreading across 28 countries where monkeypox is non-endemic, as well as 1,536 suspected cases between 13 May and 8 June from eight endemic countries in the African region. Seeing the potential need for increased monitoring, this partnership is expected to aid in understanding the global spread of the virus.

Becton Dickinson is not the first company to be creating tests for the monkeypox virus. Several companies are developing their own version of monkeypox testing in preparation for a higher demand for these products. F Hoffmann-La-Roche and its TIB Molbiol subsidiary have already developed three LightMix Modular Kits, the first of which identifies all orthopoxviruses, which includes smallpox, horsepox, cowpox and monkeypox. The second kit identifies specifically the monkeypox virus. The third kit both identifies the orthopoxviruses and clarifies if the monkeypox virus has been detected. Abbott Laboratories has also been developing test kits and Trivitron Healthcare, a medical device company in India, has developed its own four-colour fluorescence-based kit, which can complete its testing in an hour.

The Covid-19 pandemic has shown significant value to companies in the in vitro diagnostics (IVD) space; the total market value for Covid-19 testing last year was $49.4bn, of which F Hoffmann-La-Roche, Abbott Laboratories and Becton Dickinson had a market share of 18.3%, 10.1% and 3.1%, respectively. Companies are preparing for a projected drop-off in revenue from Covid-19 testing as the threat of the disease subsides. The development of these new testing kits may result in early capitalisation on the increased spread of the monkeypox virus to offset those losses in revenue.

Due to the Covid-19 pandemic, medical companies have learned to rapidly develop IVD testing. In the event of a larger outbreak of the virus, these products are readily available. As the presence of the monkeypox grows, more companies may produce their own method of testing.

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