2019-nCoV diagnostics ramp up in China, globally

Companies and government organizations have started large-scale deployment of diagnostics to diagnose and screen for 2019-nCoV.

If secondary transmission of the virus occurs on a large scale outside China, diagnostics will be essential for effective treatment of individual patients and for containment.

BGI Genomics Co. Ltd. (SZSE:300676) announced Thursday that it has started trial operations at a laboratory in Wuhan that was constructed in five days.

The Huo-Yan or “Fire Eye” laboratory is equipped with high-throughput sequencing equipment manufactured by BGI subsidiary MGI Tech Co. Ltd. and is designed to handle 10,000 samples daily to detect the virus, according to BGI.

Separately, the U.S. CDC announced Thursday that it has started shipping 2019-CoV diagnostic test kits. The CDC real-time RT-PCR diagnostic panel is being distributed under an FDA Emergency Use Authorization that was approved on Feb. 4.

“Initially, about 200 test kits will be distributed to U.S. domestic laboratories and a similar amount will be distributed to select international laboratories,” CDC said. “Each test kit can test approximately 700 to 800 patient specimens.”

The CDC operates one of 15 laboratories in 14 countries that the World Health Organization has identified as reference testing labs for 2019-nCoV. WHO has made 250,000 tests available to WHO Regional Offices and national laboratories.

In addition, it is evaluating the potential to use existing commercial coronavirus assays, such as those developed for SARS, to detect 2019-nCoV with high sensitivity.

At least 20 companies and academic centers around the world have announced that they are developing molecular diagnostic test kits tailored to 2019-nCoV.

Berlin-based TIB Molbiol GmbH has developed 2019-nCoV assays that run on Roche’s LightCycler 480 instruments, Roche (SIX:ROG; OTCQX:RHHBY) told BioCentury. Roche is the exclusive distributor for these assays. In 2016, TIB Molbiol partnered with Roche on an assay for the Zika virus that was distributed under an FDA Emergency Use Authorization.

The Roche Molecular Diagnostics Infectious Disease Emergency Response Team is working on an assay design for the company’s cobas 6800/8800 systems, the company said.

Thermo Fisher Scientific Inc. (NYSE:TMO) is marketing a real-time PCR kit for the detection of RNA from 2019-nCoV.

GenapSys Inc. Thursday announced $75 million in a venture debt financing from Oxford Finance to fund global distribution of its low-cost shoebox-sized sequencer. The financing comes a few months after it raised $90 million in a series C round (see “GenapSys Rolls Out a Smaller, Cheaper Sequencer”).

The GenapSys sequencer, which sells for about $10,000, could be deployed at hospitals, airports and other sites in China, CEO Hesaam Esfandyarpour told BioCentury. Prior to the 2019-nCoV outbreak, the company had plans to start distributing its sequencers in China in late February or early March, but the schedule could be accelerated, he said.

The company is planning to distribute its product throughout the Asia-Pacific region, including Singapore, South Korea and Japan.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus. The 2019n-CoV content is free to all who visit the site.

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