PARIS & CAMBERLEY, England--(BUSINESS WIRE)--Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that its test for COVID-19 (Z-Path COVID-19-CE IVD) has been listed as eligible for World Health Organization (WHO) procurement under the WHO Emergency Use Listing (EUL) process. The test will be eligible for procurement for one year, unless circumstances dictate otherwise. The test has been developed by Novacyt’s molecular diagnostics division, Primerdesign, based in Southampton, UK.
The EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. It will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data. The procedure is a key tool for companies wishing to submit their products for use during health emergencies.
Graham Mullis, Chief Executive Officer of Novacyt, commented:
“The Emergency Use Listing by the WHO importantly provides further validation of our COVID-19 test and gives government agencies around the world further confidence in the effectiveness of our test.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
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's lead business units comprise of Primerdesign and Lab21 Products, supplying 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
Researchers at the Chinese Centre for Disease Control and Prevention and their collaborators have sequenced the 2019 novel coronavirus (COVID-19) pathogen from patient samples and have found it to be genetically distinct from the severe acute respiratory syndrome (SARS) virus that caused an epidemic in 2002 and 2003, as well as from the Middle East respiratory syndrome (MERS) virus that was detected in 2012.