KYOTO -- Japanese biotechnology company Takara Bio has developed a method to simultaneously process more than 5,000 polymerase chain reaction tests, which can screen for the new coronavirus, in just under two hours.
The new method will allow faster and more large-scale testing than the technique developed by Swiss pharmaceutical Roche. Takara Bio is currently applying for Emergency Use Authorization from the U.S. Food and Drug Administration, and is expected to receive approval soon. The new way of testing will help officials prepare for a much-feared second wave of infections.
Jointly developed by Takara Bio's U.S. subsidiary, Takara Bio USA, and Arizona-based bioSyntagma, another biotechnology company, the new method puts testing reagents for the coronavirus to practical use, allowing 5,184 cases to be processed at once. Equipment will be manufactured by Takara Bio USA.
In the PCR test, a patient's mucus or saliva is collected, after which reagents are used to make a massive number of copies of genetic material. These can be used to identify the presence of the virus. Roche's testing equipment is already in use worldwide and can perform up to 4,128 tests at once, but requires 24 hours to return results.
The company has prioritized the U.S. market because, in addition to the speed offered by Emergency Use Authorization, most companies and research institutes have their applications first approved in the U.S.
In Japan, approval is thought to be more difficult because new techniques must first be commonly accepted.
Takara Bio sees a need for large testing systems in countries like the U.S., where infections have rapidly increased and where there are fears of a second wave of new cases.
Currently, there are about 30,000 new cases per day in Brazil, and the contagion is also rapidly spreading in India.