DeZwarteRidder schreef op 10 maart 2020 10:59:
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Launch of CE-IVD Marked
novel coronavirus test
Paris, France and Camberley, UK - 17 February 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, is pleased to announce that its molecular diagnostics division, Primerdesign, has launched its CE-Mark molecular test for the clinical detection of the novel coronavirus (COVID-19).
The Directors believe that Primerdesign's COVID-19 test is the first CE-Mark test for the 2019 strain of novel coronavirus and follows the Company's rapid launch of its research use only (RUO) coronavirus test on 31 January 2020. As a result of the CE-Mark, the Company's COVID-19 test can be used directly by laboratories and hospitals for the testing of patients without the need for validation by clinicians. The Company anticipates increased demand for its test for COVID-19 due to this extended use for clinical diagnosis.
Primerdesign has already received requests for quotations for 288,000 CE-Mark tests since they were made available to pre-order on 14 February 2020. The Company has received orders for 40,000 RUO tests and requests for quotations for an additional 35,000 RUO tests prior to the launch of the COVID-19 clinical version. Demand for the tests has come from China, the US and the UK, as well as many other countries around the world.
The Company continues to see a high conversion rate from quotations to orders. However, it is difficult to predict how demand for the test will grow as the epidemic is still in its early stages. Since the initial reports of COVID-19, the Company has invested in manufacturing capacity to meet the current and potential future demand for its tests.
The Primerdesign test is being formally evaluated by public health authorities from five countries and the Company is in discussions with these organisations to potentially support their national screening requirements for COVID-19.
As previously announced, the Company has submitted an application to, and remains in discussion with, the US Food and Drug Administration (FDA) for Emergency Use Approval (EUA) of its test for COVID-19, which would allow laboratories in the US to use the test for clinical diagnosis on a temporary basis. The data generated from the CE-Mark approval will be used to support this application.