InscoBio "Oncotag, Cancer Diagnostic Kit ‘M-CF01’ Obtains MFDS Manufacturing Certification"

[Asia Economy Reporter Hyunseok Yoo] InscoBi announced on the 14th that its domestic antibody-based diagnostic kit development subsidiary, Oncotag Diagnostics (hereinafter Oncotag), has obtained manufacturing certification from the Ministry of Food and Drug Safety for the ‘Oncotag-M ICF kit, M-CF01’ product utilizing the MARS1 antibody.

M-CF01 is a ready-to-use diagnostic kit capable of detecting the MARS1 protein, which is overexpressed in cancer cells, through immunofluorescence staining of immune cells. Clinical studies conducted at multiple domestic institutions, centered on the Department of Gastroenterology at Yonsei University Gangnam Severance Hospital, confirmed that it has higher diagnostic accuracy in bile duct cancer cells compared to the existing staining method (PAP stain). A related paper was published in May in the overseas GIE (official journal of the American Society for Gastrointestinal Endoscopy).

Through this manufacturing certification, Oncotag plans to commercialize domestic and overseas cancer diagnostic businesses by developing and obtaining approval certification for in vitro diagnostic devices for cancer tissue examination, including the ‘Oncotag-M IHC Ab, M-HC01’ for cancer cell detection. Additionally, it is actively pursuing the development of immunocytochemical in vitro diagnostic devices and rapid diagnostic devices (ROSE) utilizing MARS1.

Choi Dongjae, CEO of Oncotag, stated, “This manufacturing certification and the publication of the GIE paper reaffirm the clinical utility of MARS1, which Oncotag is developing as a cancer marker.” He explained, “Cancer diagnosis using the MARS1 antibody is the world’s first development, and we will proceed with new medical technology recognition as a diagnostic marker for various cancers such as bile duct cancer, pancreatic cancer, lung cancer, and thyroid cancer through clinical data.”

He added, “Based on this achievement, we expect it to serve as an opportunity for development utilizing various biomarkers. Oncotag is currently in the process of applying for reimbursement for the M-HC01 product, which can stain tissues, in addition to this product, and plans to attract large-scale investment in the second half of the year for additional product research and development and new diagnostic area development.”