Novacyt, a global specialist in clinical diagnostics, is pleased to announce that its molecular diagnostic division, Primerdesign, has launched its CE-Mark molecular test for clinical detection of the new coronavirus (COVID-19).
Directors say Primerdesign’s COVID-19 test is the first CE-Mark test for the 2019 strain of the new coronavirus and follows the company’s rapid launch of its single-use research coronavirus (RUO) test on 31 January 2020. Thanks to the CE marking, the company’s COVID-19 test can be used directly by laboratories and hospitals to test patients without needing to be validated by clinicians. The company anticipates an increase in demand for its COVID-19 test due to this expanded use for clinical diagnosis.
Primerdesign has already received quote orders for 288,000 CE marked tests since they were pre-ordered on February 14, 2020. The company has received orders for 40,000 RUO tests and requests for quotes for 35,000 additional RUO tests before the launch of the clinical version of the test for COVID-19. The demand for these tests has come from China, the United States and the United Kingdom, as well as many other countries around the world.
The company continues to see a high conversion rate from quotes to orders. However, it is difficult to predict how the demand for this test will increase, as we are still in the early stages of the epidemic. Since the first reports of COVID-19, the company has invested in its manufacturing capacity to meet current and potential future demand for its tests.
The Primerdesign test is currently being officially evaluated by public health authorities in five countries and the company is in discussions with these organizations to possibly support their national requirements for COVID-19 screening.
As previously announced, the company has submitted an application to the U.S. Food and Drug Administration (FDA), with which it is still in discussions, for Emergency Use Approval EUA approval of its COVID-19 test. , which would allow US laboratories to use the test for clinical diagnostic purposes on a temporary basis. The data generated by the approval of the CE marking will be used to support this request.
Graham Mullis, CEO of Novacyt said:
“I am very pleased to announce the launch of our COVID-19 CE-Mark test, which we believe is the first CE-Mark test for the clinical diagnosis of the 2019 strain of the new coronavirus. Like our disposable research test, it can produce a result in less than two hours, with the added efficiency of being able to transport the test at room temperature, eliminating the need for cold chain transport. It is designed to work on multiple instrument platforms commonly used by clinical laboratories around the world, ensuring that our COVID-19 test can be used by as many clinicians as possible. We look forward to continuing to support clinicians in the fight to contain the spread of the new coronavirus during this public health emergency. “
