Adding again4 Apr 2020 12:17
The rate of exponential growth in demand is demonstrated by Novacyt from 27 February 2020 having sold over £0.93m (€1.1m) of CE-Mark Pimerdesign tests and research use only (RUO) tests. To then as of 27 March, Primerdesign selling and receiving orders for over £17.8 million (€19.6 million) of its CE-Mark and research use only (RUO) COVID-19 tests. As of 27 March, Primerdesign received its largest single order to date of £1.4 million (€1.5 million) from a new customer in India following emergency use approval of the test on 26 March 2020. Its COVID-19 test is now selling to more than 80 countries and the Middle-East is becoming the strongest selling region, with orders of £1.6m (€1.8m) received in less than two weeks. The Company expects to sign further distribution partnerships during the next few weeks in this region and also expects to update on its progress in the US market following Emergency Use Authorization granted by the US Food and Drug Administration announced on 23 March 2020. Its COVID-19 test is now being used by the Health Service Executive in Ireland and orders for £1.1 million (€1.2 million) tests have been received. Primerdesign has also signed its first major distribution agreement for the COVID-19 test with Brucker to supply the test to two Asian territories outside mainland China with initial sales 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.
Simply put however Novacyt has now reaching its maximum manufacturing capacity.
Its manufacturing partner, located in mainland Europe, BioType Diagnostic GmbH (BioType). BioType, based in Dresden, Germany, is scaling-up manufacturing and the first batches of product have been delivered to Primerdesign's Southampton site for final assembly. The level of output contracted with BioType, which, combined with the capacity from Southampton, will enable the Company to produce more than 4 million tests per month.
As to the test Public Health England (PHE) is evaluating the test in a formal evaluation process, which is expected to conclude next month. In the interim Novacyt is now supplying more than 21 hospitals across the country. Its test though covers 1,700 known variations of COVID-19.
As to the expanded demand Novacyt is purchasing additional raw materials to produce a total of 18 million COVID-19 tests. It is difficult to pin down the cost of the test due to the sensitivity of private companies looking as if they are profiting from the crisis but I believe they go for $550 – $1,000 (heavily caveated however).
As mentioned the manufacturing capacity is no way near enough for the demand and in addition to BioType scaling up it is inevitable that Yourgene and other 3rd parties will benefit from some overspill.