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.
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.
Source: Medical Dialogues