Shanghai Geneodx gets European approval for coronavirus tests

Shanghai Geneodx Biotechnology Co Ltd, a genomic sequencing subsidiary of China National Biotech Group Co Ltd under Sinopharm, announced it had acquired European Conformity approval of its self-developed 2019-nCoV nucleic acid detection kits, giving it the green light for offering assistance to the world in the fight against COVID-19.

CE approval — a certification for diagnostic medical devices sold in Europe — entitles Geneodx's detection kits to be sold in the European market. The approval is regarded as a blessing for the world, as the crisis wrought by the outbreak of the COVID-19 pandemic is finally ending in China, while its sweep continues unabated in other countries.

Cheng Luxiang, vice-general manager of Geneodx, said sufficient supply of high-quality test kits is crucial to guarantee testing for the virus. In China's fight against the epidemic, Geneodx's test solution was widely used, offering a scientific basis for diagnoses of confirmed cases and discharges of recovered patients.

The life science firm, which had accomplished nearly 1 million tests in the domestic market by Mar 23, is now eyeing the overseas market, where more assistance is needed.

"As COVID-19 is evolving into a pandemic, we regard it as our responsibility to take the lead in aiding the world against the virus," he said.

Wang Peijun, chairman of the committee of the radiology branch under the Shanghai Medical Association, said even though computerized tomography imaging offers valuable guidance for COVID-19 detection, the nucleic acid test is still a gold standard for confirmed cases, as CT image shadows could be caused by other lung diseases.

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

On March 12, medical experts from CNBG joined a working group organized by the Red Cross Society of China and flew to Italy to help the country combat the epidemic.

With CE approval of its detection kits, Sinopharm is expected to offer more assistance to the world in this fight, the company said.