Precision Biosensor's Nano-Check test kit wins FDA EUA

Precision Biosensor said Tuesday its Covid-19 test kit won an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).

The Nano-Check test kit, developed by Precision’s Nano-Ditech U.S. subsidiary, is a kit that can be used at Covid-19 testing sites by medical professionals. They produce results within 15 minutes.

The test kit can also detect various coronavirus variants, including Omicron and Delta, the company said.

The kit has 90.32 percent sensitivity and 100 percent in specificity. The sensitivity of a clinical test refers to the ability to correctly identify those patients with the disease, which means a test with 100 percent sensitivity correctly identifies all patients with the disease. Specificity is the ability of the test to correctly identify those patients without the disease.

“Demand for test kits remains high, especially in public facilities and medical sites,” said an official from Precision Biosensor. “As there are only a few kits that received approvals from the FDA, we anticipate that we could supply the test kits to many countries in North America, as well as Latin America soon.”

Precision Biosensor said the EUA from the FDA will allow the company to strengthen its presence in the global markets. Precision has been exporting its test kits to European countries and Russia.

Precision Biosensor jumped 12 percent to close at 12,150 won ($10.3) Tuesday.

BY SARAH CHEA [chea.sarah@joongang.co.kr]