BEIJING – Chinese regulators are speeding up to approve more test kits for the deadly coronavirus that already has killed 170 people and infected more than 7,700 globally. Companies also are working around the clock to develop better products and maintain supplies.
The virus-hit country handed down approvals for four nucleic acid test kits Jan. 26, then two more in the next two days. These test kits were developed by Shanghai Geneodx Biotech Co. Ltd., Daan Gene Co. Ltd., Shanghai ZJ Bio-tech Co. Ltd., Huada Biotechnology (Wuhan) Co. Ltd., and Sansure Biotech Inc. More products are waiting for the green light.
As more test kits have reached the public, the number of people confirmed to be infected by the coronavirus in China soared from 547 Jan. 22 to 7,766 as of Jan. 30. The coronavirus has spread to as far as Tibet, with more cases being confirmed.
“The National Medical Products Administration (NMPA) has activated the emergency approval procedures for medical devices since the outbreak of the disease,” the NMPA said Jan. 26. “We will continue to adopt this special approval channel to speed up the marketing of the products.”
Local medical authorities in different provinces, including Guangdong, Anhui, Shaanxi, also joined the call.
While approvals are coming faster, biotechs also are vying to develop better test kits to shorten the diagnosis time.
For example, Jiangsu Qitian Gene Technology Co. Ltd., together with the National Institute for Viral Disease Control and Prevention, has claimed to have developed test kits that can produce results in eight to 15 minutes.
“The test kits come with an isothermal amplification instrument that can automatically interpret the results,” the firm said. It added that the test kits have a lower cost, and the sensitivity and specificity are both 100%.
The biotech jumped on the call to develop more efficient test kits with experts from the institute Jan. 20. The test kits entered mass production nine days later.
“We have already sent the first batch of our test kits to the Hubei province and will send more over later. We’re now waiting for marketing approval from the authorities, but it should come fast under the current green channel,” a staff person from Qitian told BioWorld.
For its part, Shaanxi Lifegen Co. Ltd. has said its test kits could detect the coronavirus in an hour, while Shanghai ZJ claimed that its offering could do so in less than two hours with absolute accuracy.
The shortage of test kits in China is delaying diagnoses, and some patients reportedly have died before they were diagnosed. As thousands have flocked to hospitals for testing, the authorities have declared developing more test kits to be a priority.
Companies such as Qitian cancelled their Chinese New Year holidays, which usually last for two weeks, to get their act together quickly. They have been racing to develop more test kits for the coronavirus since the genetic sequence of the virus was published Jan. 10. Those who have developed tests now aim to scale up production and stabilize supplies to meet the demand.
Geneodx, one of the first biotech firms that received approval for its test kits, said it planned to make products for 120,000 people and has sent them all over the country, including to Hong Kong and Macau.
Meanwhile, Huada said it will send the first batch of test kits for about 100,000 patients to areas that are hardest hit. It also will double its production in a timely manner and stock up materials to produce more. The company also is said to be working with health authorities and institutes in Brunei, Thailand, Nigeria and South Africa.
Wuhan, a city in Hubei province, remains the epicenter of the outbreak. Local authorities said in a Jan. 29 media briefing that the city has stocked 50,000 test kits so far, and diagnosis is being performed much more quickly.
Meanwhile, countries in Asia, Europe, North America and the Middle East also have reported suspected and confirmed cases.
For its part, Co-Diagnostics Inc., of Salt Lake City, has completed principle design work for a PCR screening test for the coronavirus.
The U.S. Centers for Disease Control and Prevention also has posted its assay for the virus and is now developing the test into kits. Test kits are expected to be distributed to state health departments and public health labs in the coming weeks.