Novacyt S.A. said it is seeing unprecedented demand for the novel or COVID-19 diagnostic test kit developed by Primerdesign, the company's molecular diagnostics division based in the UK.

As of March 27, Primerdesign has sold and received orders for more than 17.8 million pounds of its CE-Mark COVID-19 tests.

On Friday, Primerdesign received its largest single order to date worth 1.4 million pounds from a new customer in India following emergency use approval of the test. Novacyt also received approval for the test from the National Administration of Drugs, Foods and Medical Devices or ANMAT in Argentina.

Novacyt said it is currently selling its COVID-19 test to more than 80 countries, with the Middle-East emerging as the strongest selling region, after orders worth 1.6 million pounds were received in less than two weeks.

The biotechnology company expects to sign more distribution partnerships during the next few weeks in the Middle East. It also plans to update on its progress in the U.S. market after the Food and Drug Administration authorized the test kit's emergency use.

In Europe, Novacyt is now supplying its COVID-19 test to more than 21 hospitals across the UK. The company has also received orders for 1.1 million pounds worth of tests from the Health Service Executive in Ireland.

Novacyt said that while it cannot predict with certainty whether the ongoing enquiries will convert into orders, this level of sales will contribute significantly to improved gross margin and profitability for the Group.

The company noted that its Germany-based manufacturing partner BioType Diagnostic GmbH is scaling up manufacturing and has delivered the first batches of product to Primerdesign's Southampton site for final assembly.

Novacyt will increase the level of output contracted with BioType. Combined with the capacity from Southampton, this will enable it to produce more than 4 million tests per month.

The company is looking forward to receiving the first batches of certain product associated with its COVID-19 test from its UK-based manufacturing partner, YourGene Health Plc. In addition, the company is in advanced talks with another UK-based third-party manufacturer to further expand manufacturing capacity.

Novacyt said it has committed to purchasing additional raw materials to produce a total of 18 million COVID-19 tests.

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