NCYT4 Mar 2020 11:09
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Fri, 28th Feb 2020 07:00
RNS Number : 4158E
Novacyt S.A.
28 February 2020
Novacyt S.A.
("Novacyt" or the "Company")
Coronavirus test update
Major distribution agreement for COVID-19 test
Paris, France and Camberley, UK - 28 February 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, is pleased to provide an update regarding the novel coronavirus (COVID-19) test developed by Primerdesign, its molecular diagnostics division, and announces it has signed a major distribution agreement in Asia and an original equipment manufacturer (OEM) agreement with a US healthcare group.
As of 27 February 2020, Primerdesign has sold over £0.93m (€1.1m) of CE-Mark and research use only (RUO) tests. Since launching its CE-Mark test, the Company is experiencing high levels of interest in its product. The value of quotations has grown significantly as Novacyt is currently involved in active discussions with representatives from a number of countries which have an acute need for tests as part of their national screening programmes. Due to the high level of interest in the Primerdesign COVID-19 test and rapidly evolving nature of this outbreak, the Company cannot predict with any certainty the conversion rate of these ongoing enquiries into orders.
Primerdesign has also signed its first major distribution agreement for the COVID-19 test with a global life sciences company to supply the test to two Asian territories outside mainland China. Initial sales, which are subject to local emergency use approval, are anticipated to be £2.1m (€2.5m) during the first six months of the agreement. It is expected that the first sales under this agreement will take place in March 2020.
The Company also announces that it has signed an OEM agreement with a US healthcare group for the manufacture and sale of its RUO coronavirus tests.
In addition, as previously announced, the Primerdesign test is currently under review by the US Food and Drug Administration (FDA) for Emergency Use Approval, which would allow the test to be used for clinical diagnosis of COVID-19 in the US. The FDA and the Company are in regular contact.