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HISTORISCHE PRESTATIES
1W 1M YTD 52W
Hoogste 1,59 2,12 2,675 2,675
Laagste 1,156 0,922 0,160 0,061
% 0,78 0,78 669,23 434,98
Bijgewerkt 23/03/2020 08:10:6 CET
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PRESS RELEASE
Novacyt S.A. ("Novacyt" or the "Company"): US FDA Emergency Use Authorization for COVID-19 Diagnostic Test
23 MAR 2020 08:00 CET
COMPANY NAME
NOVACYT
ISN
FR0010397232
MARKET
Euronext Growth
SYMBOL
ALNOV
COVID-19 RUO test receives approval in Indonesia
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.”
About Emergency Use Authorization Status
The Primerdesign COVID-19 test has been authorized by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate and high complexity tests. The test has been authorized only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. It is authorised for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of SARS-CoV-2 virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorisation is terminated or revoked sooner.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.