Mega RNS12 Mar 2020 07:15
Coronavirus test update
Investment in manufacturing capacity
Paris, France and Camberley, UK - 12 March 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 invested in a significant increase in manufacturing capacity to support the growing demand for its COVID-19 test.
As of 11 March 2020, Primerdesign has sold and received orders for over £2.3 million (€2.6 million) of its CE-Mark and research use only (RUO) COVID-19 tests, which represents approximately five months of sales for the division under normal circumstances. This is additional revenue to the core Novacyt business, which has also started the year strongly. In the past two weeks, the number of countries the Company is selling its COVID-19 test into has doubled to over 50, which is expected to increase further as the virus continues to spread. Currently, the Company is seeing significant sales from Europe and from a number of new and existing distribution partners across the Middle East.
Due to the high level of interest in the Primerdesign COVID-19 test and evolving nature of this outbreak, the Company cannot predict sales with any certainty as the pipeline continues to change daily. However, it is clear that the demand for, and interest in, the Company's tests remains very high and the Directors' key focus is on ensuring Primerdesign can service the demand from as many customers as possible.
Manufacturing capacity
During the past two weeks, Primerdesign has scaled up its manufacturing capacity for the COVID-19 test and is currently meeting demand. The Company has purchased enough raw materials to manufacture 3.5 million COVID-19 tests. In addition, the Company has significantly increased its manufacturing capacity by appointing a third-party manufacturer, which specialises in high quality, GMP pharma and molecular diagnostic outsourcing and is based in mainland Europe. It is expected that the combination of the two manufacturing operations will support production of up to 2 million COVID-19 tests per month, which increases capacity by a factor of 10. This increase in output will be available within the next two weeks. The purchase of further raw materials and a further scale up of manufacturing capacity is possible under this outsourcing agreement.
Regulatory approvals and Public Health England
The Company is working closely with the US Food and Drug Administration (FDA) to meet the stringent requirements for Emergency Use Approval (EUA) of its COVID-19 test and is hopeful its application will be successful. A number of other national health agencies continue to review Novacyt's test, but the Company is unable to indicate when these approvals might be granted. As soon as an approval is granted, the Company will communicate this.
Sign In
Follow the stocks
