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Coronavirus test kits developed by Chinese firm approved for use in U.S.

2020-March-25       Source: Global Times Net

There is no doubt that the U.S. could develop the kits themselves, but the problem lies in their production capacity.

COVID-19 test kits developed by China's BGI Genomics are now commercially available in the U.S. clinical market, the company said. Industry analysts say the move could improve testing ability in the U.S. as suspected cases in the country have been rising rapidly.

The move was also interpreted by many as a positive sign that there could be more cooperation between the world's two largest economies in the fight against the coronavirus, despite tense bilateral ties.

The kits' availability in the U.S. market came after the U.S. Food and Drug Administration (FDA), in an effort to ramp up testing amid a shortage of critical lab supplies, decided to allow companies to sell tests before they have been reviewed by federal authorities or granted official emergency clearance.

BGI told the Global Times it has submitted an Emergency Use Authorization (EUA) application to the FDA for the test kits, and that the pre-EUA application has been processed by local authorities.

Industry insiders noted that applying for a license to export medical supplies to the U.S. is difficult and requires time, while the FDA's at hoc move is a "desperate" one as U.S. is facing a severe shortage of test kits. The insiders pointed out that the move could have come earlier.

"There is no doubt that the U.S. could develop the kits themselves, but the problem lies in their production capacity," which China has, Lü Mengtao, operations director of Beijing Zhimed Medical Science, told the Global Times on Tuesday.

Disrupted logistics due to the pandemic have also caused a shortage of many key lab materials and products, Lü said.

Lü noted that while local departments and hospitals are in urgent need of Chinese medical supplies, some in the White House still want to show a "strong nation's image" in the face of a public health crisis, which hinders the country's ability to fight the virus.

The Shenzhen-based genome sequencing firm said that actual sales of its products could still face uncertainties, citing reasons such as changes in overseas market policies, and detection requirements related to the prevention and control of the coronavirus.

"Future product expansion progress and the sales model of test kits are also uncertain," BGI said, adding that further sales details are not available at the moment.

BGI was among the first Chinese firms to successfully develop a test kit for the virus in late January. The company's products are also available in many countries in Europe as the firm has obtained a CE credential.

The firm can currently produce diagnostic kits for 100,000 people daily, and could "expand rapidly based on market demand."

Editor: Monica Liu

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