Boditech Med Inc. said it has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration for Swab-N-Go Home Test COVID-19 Ag, an at-home Covid-19 diagnostic kit.

Boditech Med Inc. has received emergency use authorization for at-home Covid-19 diagnostic kit, Swab-N-Go Home Test COVID-19 Ag, from the U.S. FDA.
Boditech Med Inc. has received emergency use authorization for at-home Covid-19 diagnostic kit, Swab-N-Go Home Test COVID-19 Ag, from the U.S. FDA.

The company has tried to get the EUA through Immunostics, its U.S. subsidiary, for the past year. It plans to manufacture and sell the product through its subsidiary. The company also signed a supply contract with CLIAwaived, a partner with a global sales network, including the U.S., in May.

According to Boditech, there is an active market for people purchasing at-home Covid-19 kits due to the U.S. health insurance system.

“While the EUA came a bit slower than we originally planned, we are confident that it will be a bridgehead for us to enter the U.S. market,” Boditech CEO Choi Eui-yeol said.

In addition to the home testing market, Boditech is preparing to target the point of care (POC) market.

The company is conducting clinical design in the U.S. to meet CLIA waiver criteria for three products - HbA1c for diabetes, TSH for thyroid function, and vitamin D. It plans to enter this market in phases over the next two years.

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