Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. Lab and diagnostic companies around the globe scrambling to develop and commercialize products capable of rapid and effective 2019-nCoV detection. Here’s a look at the current situation and who might be poised to win the race to market.

The CDC Test

Because the 2019-nCoV virus is so new, there are no FDA-approved commercial products for it in the US. As it has in responding to previous infectious disease outbreaks, the FDA has called on test makers to seek expedited clearance of investigational products via the Emergency Use Authorization (EUA) pathway.

In the meantime, the only test for 2019-nCoV available in the US is the reverse transcriptase real-time PCR (rRT-PCR) assay developed assay Centers for Disease Control and Prevention for respiratory and blood serum samples. On Jan. 27, the CDC published the test formula and announced that it’s using the assay to create kits for distribution to state health departments and public health labs in the next few weeks. Meanwhile, CDC labs are testing all reported US cases in accordance with agency protocol. The hope is that these temporary measures will hold down the fort until the expected stream of EUA tests hit the market.

Commercial Coronavirus Tests

Not surprisingly, labs and diagnostic companies in Asia, where the virus originated, are making progress on the commercialization front.

Veredus Laboratories

On Jan. 24, Singapore biotech firm Veredus Laboratories announced plans for a Feb. 1 commercial launch of a kit capable of detecting the coronavirus with “high specificity and sensitivity.” The VereCoV kit is based on lab-on-chip technology which integrates two molecular biological applications, polymerase chain reaction and microarray. It’s the same application that Veredus, which is currently owned by Japanese plastics giant Sekisui Chemicals, has used to create kits for detecting the Mers, Zika, Dengue and H1N1 viruses. The company claims the new kit can detect, differentiate and identify all three coronaviruses in a single test in about two hours.

Meridian Bioscience

On Jan. 27, Meridian Bioscience announced that its Lyo-Ready 1-Step RT q-PCR mix is actually being used to deal with the coronavirus outbreak. According to Meridian, labs in China are using the reagent to develop “fast and accurate” screening assay. The ready-to-use reagent is designed to improve assay accuracy, since they 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,” noted Liang Zhang, Meridian’s general manager in China. The announcement spurred a single-day 21% increase in Meridian stock.

BGI

A day after the Meridian announcement, BGI and its MGI Tech subsidiary revealed that they have received emergency clearance from China’s National Medical Products Administration (NMPA) for a pair of coronavirus products, including:

• MGI Tech’s DNBSEQ-T7 sequencer and analysis software for use in future epidemic control and prevention;
• PMseq metagenomics sequencing kit, which uses BGI’s combinatorial probe-anchor synthesis sequencing technology to rapidly detect viral sequences to identify and diagnose 2019-nCoV while running on the DNBSEQ-T7 platform; and
• BGI’s real-time fluorescent RT-PCR kit for specific testing of 2019-nCoV.

In addition to scaling up production of the assay, BGI has donated 20,000 kits to support 2019-nCoV response efforts in Wuhan and Hubei Province. BGI also said that China’s National Health Commission has authorized it as the third-party collaborator to detect 2019-nCoV in the country.

Other Potential Players

Other companies that have developed products or technologies for rapid and accurate virus screening that can potentially applied to 2019-nCoV include Oxford Nanopore and Co-Diagnostics.