French Test Produces Coronavirus Results in 2-hours

A Paris-based clinical diagnostics company announced that its molecular diagnostics division has launched its CE-Mark molecular test for the clinical detection of the novel coronavirus COVID-19.

In a February 17, 2020, press release, Novacyt SA’s CEO Graham Mullis said: “I am very pleased to announce the launch of our COVID-19 CE-Mark test, which we believe is the first CE-Mark approved test for clinical diagnosis of the 2019 strain of the novel coronavirus.”

Novacyt said the Primerdesign developed test ‘can produce a result in less than 2-hours, with the added efficiency of being able to transport the test at ambient temperatures eliminating the need for cold chain shipping.’

‘It is designed to run on multiple instrument platforms commonly used by clinical laboratories around the world, which ensures our COVID-19 test can be used by the largest possible number of clinicians.’

As a result of the CE-Mark, which is a marking certification that indicates compliance with the European Union's safety, health, and environmental requirements, the Company’s COVID-19 test can be used directly by laboratories and hospitals for the testing of patients, without the need for validation by clinicians.

Novacyt said it ‘anticipates increased demand for its test for COVID-19 due to this extended use for clinical diagnosis.’

Primerdesign has already received requests for quotations for 288,000 CE-Mark tests since they were made available to pre-order on February 14, 2020.

Demand for the tests has come from China, the US and the UK, as well as many other countries around the world.

Since the initial reports of the COVID-19 outbreak in China, the Company has invested in manufacturing capacity to meet the current and potential future demand for its tests.

The Primerdesign test is being formally evaluated by public health authorities from 5 countries and the Company is in discussions with these organizations to potentially support their national screening requirements for COVID-19.

As previously announced, the Primerdesign had submitted an application to and remains in discussion with, the US Food and Drug Administration (FDA) for Emergency Use Approval (EUA) of its test for COVID-19.

The data generated from the CE-Mark approval will be used to support this application.

“We look forward to continuing to support clinicians in the fight to contain the spread of the novel coronavirus during this public health emergency,” concluded Mullis.

On February 11, 2020, the International Committee on Taxonomy of Viruses named the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2, shortened to SARS-CoV-2.

As the name indicates, the virus is related to the SARS-associated coronavirus (SARS-CoV) that caused an outbreak of SARS in 2002-2003. However, it is not the same virus.

Recently, on February 4, 2020, the US FDA issued an EUA for the 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This FDA authorization allows the use of the test at any CDC-qualified lab across the country.

Novacyt Group is an Anglo-French biotechnology group focused on clinical diagnostics, with offices in Camberley, Surrey, United Kingdom, and Vélizy-Villacoublay, France. In May 2016 Primerdesign became part of the Novacyt SA group.

COVID-19 diagnostic testing news published by Coronavirus Today.