Novacyt S.A.: Launch of Monkeypox Assay
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Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) (“Novacyt”, the “Company” or the “Group”), an international specialist in clinical diagnostics, announces the launch of its research-use-only (RUO) polymerase chain reaction (PCR) monkeypox assay in response to the recent outbreak of the virus in non-endemic countries. The launch of this assay expands Novacyt’s genesig® real-time PCR diagnostic product portfolio and is in line with the Company’s strategy to maintain its position as a global first responder in infectious diseases.
Monkeypox is a rare viral disease, which predominantly occurs in Central and Western Africa. The monkeypox virus is zoonotic meaning transmission is primarily between animals and humans, but human-to-human transmission can also occur, through contact with skin lesions, body fluids and respiratory secretions of infected animals or humans. Clinical presentations in humans are similar to smallpox with fever, headache, swollen lymph nodes, fatigue, and muscle aches along with characteristic pox lesions.
Novacyt’s RUO monkeypox assay has been developed in two forms, genesig® easy and genesig® advanced, for detection of the virus genome (both West African and Central African variants). Both forms analyse DNA extracted from serum, lesion exudate, or scab samples from human or animal species. The genesig® advanced assay is designed to be used with any open test platform, including Novacyt’s MyGo instruments, whilst the genesig® easy assay is suitable for use on the Company’s q16 and q32 instruments. The advanced assay is quantitative if run alongside the recommended standard curve but can also be run without one and still give a qualitative result. The easy kit (q16 and q32 only) does not need a standard curve, instead software analyses the results of the sample and control to give a semi-quantitative result.
David Allmond, Chief Executive Officer of Novacyt, commented:
“Our RUO monkeypox assay has been developed in response to the recent outbreak of the virus in non-endemic countries and built around robust design principles and our real-time bioinformatics surveillance to monitor new monkeypox genome sequences. Whilst the risk of transmission of the disease to humans currently remains low, we believe our RUO assays are important tools to assist scientists and clinicians diagnose and monitor emerging infectious disease threats. The launch of this new assay further demonstrates Novacyt’s strength as a global first responder, in line with our strategy, as well as our commitment to expanding our portfolio in infectious disease.”
About monkeypox
The monkeypox virus is a double-stranded DNA zoonotic virus from the genus Orthopoxvirus. This genus includes cowpox, camelpox, mousepox, variola virus (causative agent of smallpox) and vaccinia virus (used for the smallpox vaccine). Transmission of monkeypox is primarily between animals to humans, but human-to-human transmission can occur, through contact with skin lesions, body fluids and respiratory secretions of infected animals or humans. Contact with contaminated clothing and bedding of infected individuals can also lead to transmission of the virus. The virus can be transmitted to the unborn foetus during pregnancy which can lead to stillbirth and other complications. The fatality rate of human monkeypox in unvaccinated individuals can range from 1% up to 11%, with younger age groups having the highest rate.1 More recently, the case fatality rate has been around 3-6%.2 Clinical presentations in humans are similar to smallpox with fever, headache, swollen lymph nodes, fatigue, muscle aches along with characteristic pox lesions. The incubation period for onset of symptoms can be between 5-21 days with 6-13 days being the average.2 Symptoms can last from 2-4 weeks.2
About Novacyt Group
The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company supplies an extensive range of high-quality assays and reagents worldwide. The Group directly serves microbiology, haematology and serology markets as do its global partners, which include major corporates.
For more information, please refer to the website: www.novacyt.com
1. Ježek, Z., Szczeniowski, M., Paluku, K. M., & Mutombo, M. (1987). Human Monkeypox: Clinical Features of 282 Patients. Journal of Infectious Diseases, 156(2). https://doi.org/10.1093/infdis/156.2.293
2. WHO. (2022). Monkeypox. https://www.who.int/news-room/fact-sheets/detail/monkeypox
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