On September 26th, ABC-KY announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for market approval of its MDx3000 diagnostic system in combination with KingFisher extraction instruments, which have the highest market share in U.S. laboratories. ABC-KY noted that if this application is approved, it could potentially expand its customer base to over a thousand new clients.

Before submitting the official application, ABC-KY followed FDA guidelines and conducted over 500 patient specimen tests using the MDx3000 system paired with the KingFisher Flex and Apex models. The results demonstrated that both sensitivity and specificity met the FDA's standards for product approval. The company is confident it will receive approval within the FDA’s 90-day review period.

ABC-KY highlighted that, if approved, this could lead to significant customer expansion, allowing for the further introduction of its core reagent products. These include the 17-target Gastrointestinal Pathogen Panel (GPP) and the 20-target Respiratory Pathogen Panel (RPP).

As of the end of 2023, ABC-KY’s diverse diagnostic products (IVD) had successfully been adopted by 13 major laboratory clients. By 2024, the company added 10 more clients, all of which have completed installation of the MDx3000 system. Once verification processes are completed by these clients, they are expected to begin contributing to reagent sales revenue.

Additionally, ABC-KY mentioned that revenue contributions from these new IVD clients are anticipated to begin in the fourth quarter of this year, with shipments proceeding according to client instructions. The FDA approval for the pairing of MDx3000 and KingFisher extraction instruments is expected to further drive growth momentum through 2025. As a result, ABC-KY is optimistic about the continued expansion of its diverse diagnostic IVD business.

Resource (mandarin): ABC-KY送件美國FDA 檢測方案搭配萃取儀器申請上市許可