InscoBio "Oncotag, Bile Duct Cancer Diagnostic Kit ‘M-CF01’ CE Certification... Foundation for Global Market Entry"

[Asia Economy Reporter Hyunseok Yoo] InscoBi announced on the 6th that its bio-subsidiary Oncotag Diagnostic (hereinafter Oncotag) has obtained CE certification for the product ‘Oncotag MARS1 ICF kit, M-CF01’ utilizing the MARS1 antibody.

The M-CF01 kit can detect the overexpressed MARS1 protein in cancer cells through immunofluorescence staining of immune cells and is a ‘Ready-to-use’ type kit that can be used immediately on-site. Led by the Department of Gastroenterology at Yonsei University Gangnam Severance Hospital, a domestic multi-center clinical study confirmed that it has higher diagnostic accuracy in bile duct cancer cells compared to the existing staining method (PAP Stain). Based on this, a related paper was published in the official journal of the American Society for Gastrointestinal Endoscopy (GIE), and manufacturing certification from the Ministry of Food and Drug Safety was also obtained.

Oncotag is expected to actively enter the European cancer diagnostic market based on this new CE certification acquisition. In particular, this was achieved alongside the renewal of the CE certification for the in vitro diagnostic device for cancer tissue testing, ‘Oncotag MARS1 antibody for IHC, M-HC01,’ which received CE certification last year, laying the foundation for a leap into the global diagnostic market.

Currently, Oncotag is actively promoting the development of in vitro diagnostic medical devices for immunohistochemical staining using MARS1 and rapid diagnostic devices (ROSE).

Choi Dongjae, CEO of Oncotag, stated, “This achievement not only demonstrates Oncotag’s technological capabilities but also signifies that Korea’s cancer diagnostic technology is at a world-class level. Through this certification, we will actively pursue sales by securing distribution networks and establishing marketing channels to successfully enter overseas markets with our cancer diagnostic kit products.”

He added, “We plan to obtain manufacturing certification and CE certification for other products currently under research and development as soon as possible. We will secure a diverse product portfolio with global certifications and grow into a leading global company in the cancer diagnostic field.”