The French clinical diagnostics specialist Novacyt has announced FDA authorization for its fast and easily transportable test for the coronavirus disease COVID-19. The company is also rolling out the kit this week via manufacturing and distribution partnerships across Europe.
The test received an Emergency Use Authorization from the FDA, which means it can only be used for the detection of the Covid-19 coronavirus in certified labs, and only during the national state of emergency. The test was first launched as a research-only test at the end of January, and received EU approval as a diagnostic test in mid-February.
Across the pond in Europe, Novacyt has teamed up with the UK contract manufacturing company Yourgene Health to support the production of the test, developed by Novacyt’s molecular diagnostics UK division Primerdesign. Alongside this, Novacyt signed a distribution agreement with the molecular diagnostics branch of US company Bruker to roll out the test in European countries.
The number of Covid-19 cases recently exceeded 450,000 globally, reinforcing a call from Tedros Adhanom Ghebreyesus — the World Health Organization’s Director General — to “test, test, test” for the virus. This has led to massive demands for detection kits in the global fight against the SARS-CoV-2 coronavirus, which causes Covid-19.
Novacyt is one of the leading companies in the push for new molecular diagnostic tests for coronavirus. Another example is Roche, whose detection method was granted FDA approval last week. We can expect to see more announcements soon, notably from Qiagen and BGI America, as governments worldwide announce plans to buy millions of detection kits to help curb the outbreak.
“We look forward to working with Yourgene as we continue to ensure we are fully prepared to meet the demand for our test to support the global response to monitor and contain the Covid-19 pandemic,” said Graham Mullis, CEO of Novacyt in a public statement.
Novacyt’s test kit is based on detecting viral genetic material, RNA, gathered by a swab test of the nose or throat. The RNA is isolated from that sample and detected using qPCR, a method that amplifies genetic material. While RNA detection methods are the current standard for confirming the virus in patients, the results typically take up to four hours and require specialized equipment to run. Novacyt claims its test to be an improvement on kits already available.
“Novacyt’s test is designed to only detect the SARS-CoV-2 virus and the test can produce a result in less than two hours,” Adam Herridge, Product Manager at Primerdesign, told me. “Novacyt’s test is designed to run on multiple instrument platforms commonly used by clinical laboratories around the world, which ensures the test can be used by the largest possible number of clinicians.”
The company also freeze-dries kit reagents for ease of transport and storage. This is not a standard practice with kits developed by other manufacturers, which Novocyt says makes its test ideal for tropical climates and low-resource settings.
In addition, the company is also tracking mutations within the coronavirus worldwide to ensure their tests remain up to speed with the outbreak, which could form new strains and make containment efforts harder.
David Kirk is a freelance writer and communications consultant with interests in synthetic biology, biotech, and sustainability. He has a PhD in molecular microbiology and has industrial experience developing living medicines.
Images from Shutterstock