Hong Kong biotech company Phase Scientific said Tuesday that the Ministry of Health had approved its COVID-19 rapid antigen test kits for commercialisation.
In a statement, the company said the test kits — marketed as Indicaid — provided results within 20 minutes with no special equipment or facilities needed.
The Hong Kong Government has endorsed Indicaid as a “designated product for hospital and care home visitation,” it said, adding that the test was the “top selling brand of its kind with over 2 million kits sold.
“It has also been widely adopted in hospitals, government and private corporations, supermarkets, hotels and schools for regular screening both locally and internationally.”
Phase Scientific also said that Indicaid’s accuracy had been validated in the world's largest dual-track clinical trial — where it was tested against polymerase chain reaction (PCR) tests in over 9,200 samples, showing “high sensitivity and specificity.”
The company said the test kits were now available in 33 countries, and in the process of obtaining emergency use authorisation from the U.S. Food and Drug Administration.
"We welcome the Cambodian Government's decision and look forward to bringing our rapid test kits to support its neighbouring countries as well,” chief executive Ricky Chu said.
Founded by bioengineers from UCLA with support from the Bill &amp;amp;amp;amp; Melinda Gates Foundation, Phase Scientific is based in Hong Kong with research and development as well as manufacturing facilities in southern California.
Clinical trials and commercialisation activities are based in Suzhou in eastern China’s Jiangsu province.
Source: Agency Kampuchea Press