[Market Focus] Precision Bio Shares Surge on News of FDA Approval for U.S. Subsidiary's Diagnostic Kit

As of 9:41 a.m. on June 20, shares of Precision Bio were trading at 4,040 won on the KOSDAQ market, up 15.1% from the previous day's closing price. This marks a second consecutive day of strong gains, following the company's announcement the previous day that its U.S. subsidiary had received FDA approval for a diagnostic kit capable of simultaneously detecting COVID-19 and Influenza A·B, which sent the stock to its upper limit.

Precision Bio is a specialized in vitro diagnostics (IVD) company that provides clinical diagnostic solutions based on its diverse disease marker detection technologies. The company was founded in 2009 as Terawave and has continuously advanced its optical analysis device manufacturing technology. In 2015, it acquired Nano-Ditech, a U.S.-based diagnostics specialist with antibody and POCT immunodiagnostic cartridge development and production capabilities, as a wholly owned subsidiary, laying the foundation for its growth as a global IVD company. In October of last year, the largest shareholder changed to Kwangdong Pharmaceutical, known for its 'Vita500' product.

On June 19, Precision Bio announced that its subsidiary Nano-Ditech's combo diagnostic kit, 'Nano-CheckTM Influenza+COVID-19 Dual Test,' capable of simultaneously detecting COVID-19 and Influenza A·B, had received formal FDA approval (510(k)) in the United States.

According to the company, the 'Nano-CheckTM Influenza+COVID-19 Dual Test' is a point-of-care (POC) product designed for professional use in hospitals, pharmacies, and public health centers. This is the first time a professional-use combo product has received formal FDA approval, and it is the fifth overall when including home-use combo products.

With this approval, Nano-Ditech now has a total of three respiratory infection diagnostic products in its portfolio, including a COVID-19-only diagnostic kit and an RSV diagnostic kit that had previously received FDA approval.

A company representative stated, "As the incidence of respiratory infectious diseases continues to rise, the diagnostic market is expected to grow. With the addition of FDA-approved, performance-verified products to our lineup, in addition to those developed in-house by Precision Bio, we anticipate being able to meet a wide range of market needs."