Access Bio, COVID-19 Diagnostic Kit Receives FDA Emergency Use Authorization

[Asia Economy Reporter Eunmo Koo] Access Bio, a KOSDAQ-listed company, has obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 diagnostic kit.

On the 9th, Access Bio announced that the FDA had granted final approval for the EUA application of its COVID-19 molecular diagnostic kit. The approved COVID-19 molecular diagnostic kit, CareStart™ COVID-19 MDx RT-PCR, amplifies two specific genes of SARS-CoV-2 using nasopharyngeal and oropharyngeal swab samples to increase sensitivity, and diagnostic results can be obtained within two hours.

With the ability to sell the COVID-19 molecular diagnostic kit in the U.S., Access Bio plans to produce the product locally to minimize lead time and maximize competitiveness. A company representative stated, “Although the New Jersey plant is primarily specialized in rapid diagnostic tests (RDT), during the early spread of COVID-19, molecular diagnostic production facilities were quickly established within the New Jersey research center, enabling molecular diagnostic production as well. This approval is an important stepping stone for Access Bio to expand its sales proportion in advanced markets and secure a product lineup including molecular diagnostics.”

He added, “We plan to expand supply not only in the U.S. but also in global markets through the overseas distribution channels we have built over time and the sales capabilities of our largest shareholder, Wooridul Pharmaceutical.”

This content was produced with the assistance of AI translation services.