As the deadly coronavirus continues to spread, countries around the world are scrambling to understand the public health threat and identify and quarantine people who may be infected. To that end, Novacyt SA has launched a molecular test that detects only the 2019 strain of the coronavirus, reducing the chance of false diagnoses.

Since China first announced reports of a pneumonia-like illness in the city of Wuhan on Dec. 31, 2019, there have been more than 17,000 confirmed cases of novel coronavirus (2019-nCoV) in the country and 360 deaths. About 150 cases have been reported in two dozen other countries, with the Philippines reporting the first death outside of China. So far, the U.S. has identified 11 cases of infection.

Of particular concern in containing the disease is the knowledge that people can spread the virus before showing symptoms. Last week, the World Health Organization declared 2019-nCoV a public health emergency of global concern, and Alex Azar, secretary of the U.S. Department of Health and Human Services, elevated the threat to a public health emergency in the U.S. The Centers for Disease Control and Prevention is closely monitoring the situation.

High specificity

The test developed and launched by Novacyt’s molecular diagnostics division, Primerdesign, is a quantitative polymerase chain reaction (qPCR) assay that “specifically targets the unique genome sequences of the 2019-nCoV strain of the virus,” Graham Mullis, CEO of the Paris-based company, told BioWorld. By validating it with the specific sequence of the genome found in the new strain of the virus, the test delivers high levels of assay performance, particularly specificity – an advantage over tests that may react to related species, he said.

The Novacyt test is designed to run on multiple molecular testing platforms, including Primerdesign’s Genesig q16 and 132 instrument, making it suitable for large and small laboratories. It is also stable at ambient temperatures, removing the need for cold chain shipping, which could reduce transportation costs and loss of product.

Novacyt is currently making the test available to laboratories as a research use-only assay throughout its sales channels, and has seen strong, early demand from more than 10 countries. As for broader availability, the company is still determining the best route forward.

“In the event a manufacturer pursued full regulatory approval for clinical use, it could take six months or more with regulators such as the FDA,” he said. “There is an emergency use process with most regulators, and this might reduce the time for a limited approval within weeks, depending upon the criteria the regulators require.

Novacyt’s stock rose 32% Jan. 31 on news of the launch. The company introduced the test this past weekend at the Medlab Expo in Dubai.

For 2019, Novacyt reported revenue of €13.1 million (US$14.5 million), down 5% on a consolidated basis from 2018. The year was marked by the sale of two non-core businesses, Novaprep to Belarus-based Algimed Trade Ltd. and clinical laboratory to Cambridge Pathology BV, which followed a strategic review completed in December 2018.

Race to develop tests

Other companies are rushing to meet the demand for coronavirus testing as well. On Jan. 28, Salt Lake City-based Co-Diagnostics Inc. reported that it had successfully completed initial verification of an assay to screen for the presence of 2019-nCoV and would be ready to begin distributing its tests to affected markets soon.

Also last week, Austrian diagnostics company Ares Genetics GmbH announced a collaboration with BGI Group to make molecular tests for the new coronavirus available in Europe. The next-generation sequencing service will use BGI reagents. BGI has developed a real-time fluorescence PCR kit for detecting the strain, which produces results in several hours. The test kit has been approved by China’s National Medical Products Administration, and BGI said it has shipped about 50,000 kits to hospitals and disease control centers in China.

Also in the game is Cincinnati-based Meridian Bioscience Inc. The company recently touted its molecular diagnostic test in detecting 2019-nCoV. “The advantage of the Meridian Lyo-Ready 1-Step RT-qPCR Mix is that the assay can be set up and freeze-dried, so that they are highly stable, just requiring the patient sample to be added and the assay run,” said Liang Zhang, general manager for Meridian in China. “This means that patients can be screened very quickly to help stop the spread of the virus.”

Other companies still are monitoring the situation. In a roundup of comments on the potential impact of the coronavirus, released by Wells Fargo analyst Larry Biegelsen, Becton Dickinson said it is doing what it can to support those on the front lines of the crisis. “While BD does not have an official diagnostic test for the coronavirus, we have seen a number of additional orders in the last few weeks for our BD Max molecular system in China as it is an open system and local officials are looking to develop their own content to run tests.” The uptick is not expected to have a significant impact on business.

Resmed Inc. said it expects to see higher demand for ventilators, as occurred during the 2002 SARS (severe acute respiratory syndrome) outbreak. “We’re actually working hard on our local supply chain” in China, the company said.

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