Roche and Meridian Among Vendors with 2019-nCoV-related IVD products; FDA Steps in.

Major IVD vendors, especially those common in reverse transcription PCR (RT-PCR), went right to work in the recent coronavirus outbreak.  This as the FDA announced plans to make emergency test deployment easier.  The recent novel coronavirus, responsible for thousands of infections and over 170 deaths in the Hubei province in China at the time of writing, undermines any notion of a known quantity of infectious disease threats in the world that lab analyzer menus will remain adequate.

Kalorama Information projects the infectious disease IVD testing market to be worth more than $18 billion, according to its latest complete world infectious disease market research report, with revenue growth higher than the 4% of normal testing markets.

2019-nCoV is a betacoronavirus, like MERS and SARs, all of which have their origins in bats. The sequences from U.S. patients are similar to the one that China initially posted, suggesting a likely single, recent emergence of this virus from an animal reservoir.

Meridian Biosciences said that the firm’s  freeze-dried  Lyo-Ready 1-Step RT-qPCR Mix is being used in the current crisis in China.   The firm said that after sequencing of the novel coronavirus (2019-nCoV), their  qPCR master mixes and enzymes are being extensively used in fast, sensitive molecular tests. In addition Meridian offers antigens and polyclonal antibodies for serological testing.

As could be expected, China’s BGI is on the case with a DNA Test Kit. According to news reports, BGI has now released a total of 40,000 test kits to hospitals and disease control centers around China. They noted that they can produce about 50,000 kits a day and have about 100,000 in stock.

Oxford Nanopore is working with a number of public health laboratories, in China and elsewhere, to support the rapid sequencing of the novel coronavirus that was first seen in Wuhan, China. Nanopore said that “Sequencing the virus can support ‘genomic epidemiology’- characterising the virus and helping public health authorities to understand the identity of the virus, whether it is changing and how it is being transmitted – all in conjunction with other epidemiological data.”

Roche and PharmaMar subsidiary Genomica are among the companies that are introducing tests for the novel 2019-nCoV coronavirus, fulfilling an urgent global need for swift diagnosis. The coronavirus has raised alarm bells since it began spreading from its origin in Wuhan, China, in early January. As of January 30, there were 8,246 confirmed cases worldwide and 170 deaths, with all the fatalities reported in China. Also on January 30, the World Health Organization (WHO) declared that the 2019-nCoV outbreak is a public health emergency of international concern (PHEIC). According to the WHO, 98 cases have been reported outside of China, including eight cases of human-to-human transmission. Scientists with the U.S. National Institutes of Health (NIH) have stressed the importance of diagnosing every case of 2019-nCoV to break the transmission chain.

In the U.S., the Centers for Disease Control and Prevention (CDC) has guided that it will be conducting all testing, which is based on reverse transcription polymerase chain reaction (RT-PCR), and has shared protocols for labs sending samples. To effectively prevent the spread of the virus, there is an urgent need to test individuals in the field, such as at hospitals and ports of entry to the U.S.

Roche and Genomica Announce Efforts

Roche discussed the launch of research-use-only tests for diagnosing the coronavirus during its fourth-quarter earnings call on January 30. Roche’s products include the LightCycler 480 and MagNA Pure 24 instruments. The company has developed the Wuhan RdRp assay, which is specific for detecting 2019-nCoV, and the Wuhan N-gene3 test, which screens for 2019-nCoV plus other related types of coronaviruses.

Genomica just announced that it is planning to make a testing kit for the coronavirus commercially available in the next five to seven weeks. The test will have the capacity to analyze 96 patient samples at the same time, with results within five hours, according to the Madrid-based company. Genomica already markets a diagnostic kit for 20 viruses that cause respiratory diseases, including coronaviruses, and has a subsidiary located in Wuhan, the source of the outbreak of the novel coronavirus. Genomica is planning to make a testing kit for the coronavirus commercially available in the next five to seven weeks. Image courtesy of Genomica. A number of other vendors have announced their test offerings. The BGI Group announced that it had developed an RT-PCR test for the novel coronavirus and that it has already issued it to many hospitals and disease control centers in China. The company, which is based in Shenzhen, China, said that it is working on the provision of test kits and next-generation sequencing technology for pathogen technology with public health groups in Hong Kong, Thailand, and South Africa.

Oxford Nanopore Technologies recently announced that it is working with public laboratories in China and other countries on rapid sequencing of 2019-nCoV to identify the virus and track its genetic evolution over time.

In addition, Co-Diagnostics has completed design work for a screening test for the new coronavirus.

FDA Takes Action

On January 28, 2020 The U.S. Food and Drug Administration (FDA) outlined steps it plans to take to advance the development of countermeasures against the novel coronavirus (2019-nCoV) in a statement released January 27.

The various efforts described by the FDA include sharing updates on processes to help product developers make medical countermeasures for the coronavirus, such as diagnostic tests, as rapidly as possible. The agency has also launched a webpage that provides key information for the public, including the FDA’s efforts in response to the outbreak.

There are currently no commercially available products that are authorized to detect the novel coronavirus, but the FDA said it is working to facilitate the development and availability of diagnostics that can detect the virus and potential treatments. The agency plans to collaborate with interagency partners, product developers, international partners, and global regulators to expedite the process.

The Centers for Disease Control has listed RT-PCR procedures and primer/probe instructions on its website.