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Pharmaceuticals

Roche seeks approval for COVID-19, flu combo test in Japan

New PCR exam by Swiss drugmaker comes as hospitals brace for winter flu season

Swiss pharmaceutical giant Roche will soon apply for approval in Japan of its reagent that detects COVID-19 and the seasonal influenza virus at the same time.

TOKYO -- Swiss pharmaceutical giant Roche will soon apply for approval in Japan of its reagent that detects COVID-19 and the seasonal influenza virus at the same time, Nikkei has learned.

The reagent can detect the virus with a high degree of accuracy if combined with Roche's testing equipment owned by medical institutions and testing companies. That also reduces the burden on patients and medical workers who are bracing for the double threat of COVID-19 and the winter flu.

The reagent is used for polymerase chain reaction, or PCR, tests. Roche Diagnostics, the Japanese unit of Roche, will soon file a drug application with the Ministry of Health, Labour and Welfare.

Roche has already applied in the US. On Sept. 3, the U.S. Food and Drug Administration granted the company the regulator's Emergency Use Authorization.

The new reagent is to be used with testing equipment Cobas 6800 and Cobas 8800 developed by Roche. A swab of mucus from the nose and throat is collected as a sample. The reagent can detect COVID-19 as well as the influenza A and influenza B viruses simultaneously with a single sample.

The testing equipment, in tandem with the new reagent, can automatically examine samples from a maximum of 96 people and takes just three hours to get results.

The testing equipment costs tens of millions of yen (hundreds of thousands of dollars) per unit. A few hospitals and testing companies like H.U. Group Holdings owns a combined 40 units nationwide.

Due to the limited availability, the new reagent is unlikely to be used for initial testing. However, it is likely to be utilized when higher accuracy is needed, such as retesting people suspected of being infected and those already hospitalized for another illness.

Nevertheless, Roche's products can be a model for exploring the future of virus testing.

Japan annually sees 10 million patients infected with seasonal influenza, while it is difficult to accurately detect who is infected with the coronavirus based on symptoms alone. Thus, if COVID-19 and influenza spread at the same time, it is highly likely that primary care doctors will be flooded with patients seeking treatment.

People in Japan who suspect infection with COVID-19 have been required to contact their local government health care center before seeing a doctor. From this autumn, the government will ask people with a fever to call the nearest primary care doctor's office, clinic or hospital first. There, doctors will use antigen tests to check for COVID-19 exposure and simple kits for flu infection.

However, there is a chance of 10% to 20% that such tests will yield a "false negative" result, meaning a missed infection. Patients who test negative but are still suspected to be infected will take a PCR test at a large hospital. Roche's reagent is expected to be used in such retesting.

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