NEW YORK – The US Food and Drug Administration on Friday granted Emergency Use Authorization for a molecular diagnostic test for SARS-CoV-2 developed by Primerdesign, the UK-based molecular diagnostics division of clinical diagnostics company Novacyt.
The Primerdesign COVID-19 Genesig Real-Time PCR assay, which received CE marking in mid-February, is a real-time RT-PCR test for the qualitative detection of SARS-CoV-2 nucleic acid in oropharyngeal swabs from patients suspected to have COVID-19. It is immediately available for distribution in the US.
The test kits include Primerdesign's master mix, relevant primers and probes, positive controls, and internal RNA extraction controls. The test is used with the GXT DNA/RNA Extraction kit and GenoXtract extraction instrument from Bruker-Hain Lifescience, and can be run on Thermo Fisher Scientific's Applied Biosystems 7500 Real-Time PCR System, Bio-Rad Technologies' CFX Connect Real-Time PCR Detection System, or Roche's LightCycler 480 II platform, according the manufacturer's insert.
Novacyt said that the test can provide results in less than two hours and is lyophilized for stable shipping at ambient temperatures.
"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," Novacyt CEO Graham Mullis said in a statement. "We are committed to providing clinicians around the world with our COVID-19 test and delighted we can now support the US market."
Novacyt, which has offices in Paris and Camberley, UK, also said that its research-use-only COVID-19 test has been approved by the Indonesian Ministry of Health.