Bioinfra Life Sciences Applies for MFDS Approval of Lung Cancer High-Risk Group Screening Test

[Asia Economy Reporter Kwon Jaehee] Bioinfra Life Science Co., Ltd. announced on the 29th that it has applied for approval of the in vitro diagnostic (IVD) device 'i-FINDER LC (lung cancer diagnostic software),' a protein biomarker-based screening test for high-risk groups of lung cancer, to the Ministry of Food and Drug Safety.

Bioinfra Life Science has been researching protein biomarkers in serum for non-small cell lung cancer (NSCLC), which has a high incidence among lung cancers. Through clinical performance trials, they developed an optimal algorithm capable of screening high-risk groups for NSCLC by using seven protein biomarkers in serum and personal information to distinguish between NSCLC (335 patients) and normal groups (312 patients).

Currently used diagnostic methods include chest X-ray and chest computed tomography (CT) as essential tests. However, while X-ray shows meaningful results in high-risk groups, the evidence for its use as a screening test is insufficient. In particular, even if abnormalities are found on X-ray, detailed examinations such as CT are required, and it is difficult to detect tumors if they are small or obscured by other organs.

CT scans also have about 80% accuracy in determining lung cancer based on tumor size, shape, and location, but tissue biopsy is necessary for an accurate diagnosis, which involves additional costs and risks of complications.

In contrast, the i-FINDER LC developed by Bioinfra Life Science is a new NSCLC diagnostic aid product that can be used as a screening test before conducting chest X-ray and CT scans used to diagnose lung cancer. It enables screening for high-risk NSCLC groups through a small amount of blood, thereby reducing unnecessary tests and costs.

Bioinfra Life Science has successfully completed clinical research and clinical performance trials for the commercialization of the i-FINDER LC product and has completed the application for approval with the Korean Ministry of Food and Drug Safety. It is expected to obtain approval as early as the first half of this year.

Kim Cheolwoo, Chief Technology Officer of Bioinfra Life Science, said, "The biomarker-based i-FINDER LC lung cancer diagnostic aid product will be useful in effectively screening high-risk groups with a high risk of NSCLC among asymptomatic general populations upon market entry, serving as an important tool to address unmet medical needs."