RE: GREAT RNS30 Mar 2020 09:16
PART 1
Sales and regulatory update
As of 27 March, Primerdesign has sold and received orders for over GBP17.8 million (EUR19.6 million) of its CE-Mark and research use only (RUO) COVID-19 tests. The rate of demand for the test continues to increase, and on 27 March, Primerdesign received its largest single order to date of GBP1.4 million (EUR1.5 million) from a new customer in India following emergency use approval of the test on 26 March 2020.
Novacyt is now selling its COVID-19 test to more than 80 countries and the Middle-East is becoming the strongest selling region, with orders of GBP1.6m (EUR1.8m) 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.
Novacyt continues to work with a growing number of hospitals in the UK and is now supplying more than 21 hospitals across the country. The Company also reports that its COVID-19 test is now being used by the Health Service Executive in Ireland and orders for GBP1.1 million (EUR1.2 million) tests have been received.
Although Novacyt is unable to predict with any certainty the conversion rate of its ongoing enquiries into orders and so provide meaningful sales guidance, the Directors can confirm that this level of sales will contribute significantly to improved gross margin and profitability for the Group.
On 27 March 2020, Novacyt received approval for the test from the National Administration of Drugs, Foods and Medical Devices (ANMAT) in Argentina.
The Company continues its extensive surveillance program to monitor strain evolution of the SARS-CoV-2 virus and the latest update continues to demonstrate a 100% homology of its COVID-19 test. To date, this means comparing the Company's COVID-19 test to genome sequences from 1,700 known variations of COVID-19. The Directors believe this extensive surveillance and performance homology will continue to allow clinicians to use the test with confidence .
Manufacturing capacity
Further to the announcement on 12 March 2020, Novacyt can confirm its manufacturing partner, located in mainland Europe, is BioType Diagnostic GmbH (BioType). BioType, based in Dresden, Germany, is making excellent progress in scaling-up manufacturing and the first batches of product have been delivered to Primerdesign's Southampton site for final assembly. In addition, the Directors have taken the decision to increase 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.
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