On July 17th (local time in the US), Boditech Med, in point-of-care diagnostics, announced that it has obtained Emergency Use Authorization (EUA) from the US FDA for its COVID-19 home test kit (product name: Swab-N-Go Home Test COVID-19 Ag).
Over the past year, the company pursued the EUA through its subsidiary, Immunostics, located in New Jersey. Going forward, production and sales will be conducted through Immunostics.
In May, in preparation for the EUA, the company signed a supply contract with CLIAwaived, which has a worldwide sales network as well as a presence across the US. The US market is active in terms of individuals purchasing test kits directly for use at home in cases of suspected COVID-19 symptoms, due to the nature of the healthcare insurance system.
Eui-yul Choi, CEO of Boditech Med, stated, "There were delays compared to the original plan for obtaining the EUA. However, in the current pandemic situation, this will serve as a steppingstone for expanding into the US market."
Boditech Med is also preparing to enter the Point of Care (POC) diagnostics market along with the home test market. It is currently conducting clinical designs in the US to meet the CLIA waiver criteria for three products: HbA1c for diabetes diagnosis, TSH for thyroid function diagnosis, and a vitamin D diagnostic product. The company plans to make a phased entry into the market within the next two years.
The CLIA waiver is a system that approves tests with low risk and ease of use as CLIA waived tests, allowing simplified and convenient testing facilities at local hospitals and pharmacies, making them easily accessible for use.