Rapid test kit maker Humasis eyes molecular diagnostics market

Humasis, which benefited from spiking sales of rapid Covid-19 test devices amid the pandemic, is gearing up for an entry into the molecular diagnostics market.

On Thursday, Humasis said it recently obtained the Ministry of Food and Drug Safety’s approval to export Humasis COVID-19 Variant RT-qPCR Kit, which can detect the Omicron variant through molecular diagnostics.

Humasis’ Covid-19 home test devices

More specifically, the product can detect Omicron and stealth Omicron, a sub-variant of Omicron, among those infected with Covid-19, the company said.

In February, Humasis obtained an export permit for Humasis COVID-19 RT-qPCR Kit, a molecular diagnostic agent for Covid-19 infection.

Humasis’ development of two molecular diagnostic agents is viewed as part of the company’s strategy to expand the scope of business.

The company plans to broaden the business portfolio from testing devices for immune response to molecular diagnostics. It had already announced a plan to increase investment in production facilities.

“We are concentrating our research capacity on expanding the product lines to enter the molecular diagnostics market quickly,” an official at Humasis said. “We plan to work on products for infectious diseases such as influenza and dengue fever and genetic diseases.”

Humasis also said that its plant in Euiwang in Gyeonggi Province obtained GMP certification for manufacturing and quality control of in vitro diagnostic devices for the local market. So far, the factory in Euiwang has been making products for export.

At the Euiwang plant, an addition of automated facility will produce up to 300,000 test devices daily. Combined with plants in Anyang and Gunpo, the total monthly capacity will reach 50 million test devices, the company said.