Novacyt gets US approval for Covid-19 test
Novacyt said on Monday that the US Food and Drug Administration has issued an emergency use authorisation for its Covid-19 test.
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The test, which is made by the company’s molecular diagnostics division, Primerdesign, is available for immediate distribution into the US market. It provides results in less than two hours and can be used on multiple ubiquitous clinical laboratory instrument platforms.
Novacyt also announced that its RUO Covid-19 test has been approved by the Indonesian Ministry of Health.
Chief executive officer Graham Mullis said: "The US FDA EUA authorisation 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."