Helping nations combat the pandemic

BGI Genomics, a Chinese company specializing in DNA/gene sequencing, is offering to the pandemic-stricken world its testing kits that can detect the novel coronavirus, or SARS-CoV-2, quickly and efficiently.

The kits are products of its own research and development, said the Shenzhen, Guangdong province-based life sciences firm.

BGI's kits have already helped detect over 500,000 infections of the coronavirus in the domestic market. The company is now shifting its focus to overseas markets.

BGI's go-global strategy comes in the wake of the COVID-19 pandemic engulfing the rest of the world even as it subsides in China.

In early March, BGI announced the CE-IVD Marking and Free Sale Certificate of its detection kit.

Yin Ye, CEO of BGI, said the CE-IVD Marking allows sales of the detection kits in both the European Economic Area (known as the EEA), and the countries outside of the EEA that have not signed the Mutual Recognition Arrangement but recognize the CE-IVD approval.

According to the company, post CE-IVD Marking, it has received many sales leads. Based on real testing demands, it is now preparing to export its detection kits to the European Union countries.

Supply of a sufficient number of high-quality kits is crucial to guarantee testing for the nucleic acid of the virus. In China's pandemic fight, BGI's test solution was and continues to be widely used, offering a scientific basis for diagnoses of confirmed cases and discharge of patients who recovered.

Yin said many difficulties arise in the process of detecting the SARSCoV-2 that causes COVID-19. For example, the virus mutates in human body, which may interfere with the detection.

To tackle the problem, BGI uses a new sequencing technology－a detection kit based on high-throughput sequencing. The new technology is able to monitor mutations that may occur during the epidemic. Apart from the SARS-CoV-2, it is also capable of detecting other possible respiratory virus infections, offering fast and accurate diagnostic results.

Wang Peijun, chairman of committee of the radiology branch under the Shanghai Medical Association, noted that although computerized tomography imaging offers valuable guidance in COVID-19 detection, nucleic acid detection is still a gold standard for confirmed cases, as CT image shadows are also demonstrated in other lung diseases.

"Nucleic acid detection and CT imaging play collaborative and complementary roles in identifying the SARS-CoV-2," he said.

According to the National Medical Products Administration, by March 30, 23 COVID-19 detection instruments were approved in China, among which two BGI kits were listed in the first batch.

According to BGI, by March 31, its detection kits had completed over 500,000 tests. The national daily throughput can reach 60,000, and is capable of further increments as needed.

Meanwhile, in the overseas market, purchase orders for BGI's detection kits surpassed 1 million, covering 70 countries and regions. The orders from Japan, Brunei, Thailand, Egypt, Peru, and the United Arab Emirates have already been honored through timely deliveries.

"With the approval of CE-IVD designation, the European market is further opened, and our detection kits may play a better role in helping the world combat the epidemic," Yin said.

Chen Qiaoshan, a medical analyst at Beijing-based market consultancy Analysys, noted that as the pandemic intensifies, there was a shortage of virus detection kits around the globe. "Although currently several companies in the world have the foundation to manufacture detection kits, a capacity relocation process is needed from product R&D to mass production."

On Mar 27, BGI announced that its detection kit received the Emergency Use Authorization issued by the United States Food and Drug Administration, marking that the product is officially qualified to be sold in the US clinical market. This is the first FDA-approval detection kit from China.

Yin said: "China's growing power of medical devices, especially IVD research and manufacturing in the last 10 years has laid a solid foundation to deal with that boom in sudden demand."

As a leading company in genomics, BGI has been laying emphasis on R&D since its establishment in 1999. In recent years, its R&D investment has increased greatly. In 2018, its R&D budget increased by nearly 50 percent year-on-year to 260 million yuan ($36.6 million), taking an over 10-percent share of sales revenues. In 2019, the company's R&D cost was estimated to range between 310 million yuan and 340 million yuan.

Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, commended China's role in completing the gene sequencing of the new virus at record speed, and in proactively and quickly sharing the crucial information with the world.

Without a detection instrument, infection cases would have been neglected, causing further spread of the pandemic. China deserves much praise. "We have seen its solid epidemic prevention and control efforts," he said.