FDA Approval23 Mar 2020 08:56
FDA Emergency Use Authorization for COVID-19 test
from Regulatory News | 23rd March 2020 07:00
RNS Number : 1209H
Novacyt S.A.
23 March 2020
Novacyt S.A.
("Novacyt" or the "Company")
US FDA Emergency Use Authorization for COVID-19 diagnostic test
COVID-19 RUO test receives approval in Indonesia
Paris, France and Camberley, UK - 23 March 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, is pleased to announce that the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its COVID-19 test. As a result, hospitals and laboratories in the US will be able to use the test for clinical diagnosis of COVID-19. The test is available for immediate distribution into the US market.
Primerdesign, the Company's molecular diagnostics division, launched the COVID-19 test as a research use only (RUO) test on 31 January 2020 and as a CE-Mark test on 17 February 2020. The benefits of the Primerdesign test include:
· Proven high performance characteristics
· Provides results in less than two hours
· Being lyophilised (freeze-dried), it is stable to be shipped at ambient temperature
· Can be used on multiple ubiquitous clinical laboratory instrument platforms
The Company is also pleased to announce that its RUO COVID-19 test has also been approved by the Indonesian Ministry of Health, which opens another new market for its test.
Graham Mullis, Chief Executive Officer of Novacyt, commented:
"The US FDA EUA authorization is another important endorsement of the performance and quality of our COVID-19 test and demonstrates once again Novacyt's growing role in tackling this pandemic. We are committed to providing clinicians around the world with our COVID-19 test and delighted we can now support the US market."
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