(Alliance News) - Novacyt SA said Monday it has launched a CE-Mark approved molecular test for the clinical detection of the novel coronavirus COVID-19.
Novacyt shares were trading 45% higher in London at 143.50 pence each on Monday afternoon.
CE-Mark is a marking certification that indicates compliance with European Union's safety, health and environmental requirements.
The clinical diagnostic company said the COVID-19 test is the first CE-Mark test for the 2019 strain of novel coronavirus and follows the company's rapid launch of its research use only coronavirus test on January 31.
"As a result of the CE-Mark, the company's COVID-19 test can be used directly by laboratories and hospitals for the testing of patients without the need for validation by clinicians," Novacyt said.
The company said its Primerdesign division has already received requests for quotations for 288,000 tests since they were made available to pre-order on Friday, and continues to see "high conversation rate" from quotations to orders.
Demand for the tests has come from China, the US and the UK, as well as many countries around the world.
"However, it is difficult to predict how demand for the test will grow as the epidemic is still in its early stages," the company said.
Novacyt said the test is being formally evaluated by public health authorities from five countries an the company is in discussions with these organisations to potentially support their national screening requirements for COVID-19.
Novacyt also said it remains in discussion with the US Food & Drug Administration for Emergency Use Approval of the test, 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, the company noted.
Graham Mullis, chief executive officer, said: "I am very pleased to announce the launch of our COVID-19 CE-Mark test, which we believe is the first CE-Mark approved test for clinical diagnosis of the 2019 strain of the novel coronavirus."
"We look forward to continuing to support clinicians in the fight to contain the spread of the novel coronavirus during this public health emergency," Mullis said.
The outbreak of coronavirus disease, that was first reported in Wuhan, China, at the end of December, has been declared a global emergency by the World Health Organisation. The number of deaths from coronavirus has risen to nearly 2000.
By Loreta Juodagalvyte; firstname.lastname@example.org
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