BibiBi, Prostate Cancer Marker Receives European Certification

[Asia Economy Reporter Hyungsoo Park] Syswork, the largest shareholder of BBB, announced on the 27th that BBB's prostate cancer-specific antigen diagnostic kit ‘MARK-B™ PSA test cartridge’ has obtained European medical device certification (CE-IVD, List B).

A Syswork official explained, "The diagnostic kit MARK-B is a handheld device that uses magnetic nanoparticles and electrochemical sensors to quantitatively and precisely detect the amount of biomarkers present in trace amounts in biological samples, based on an immunoassay diagnostic platform."

The company official evaluated, "By applying MESIA, a technology independently developed by BBB, it secured analytical accuracy comparable to the expensive large-scale testing equipment used in hospital clinical pathology laboratories."

He added, "In particular, MARK-B is equipped with ‘power-free automatic plasma separation technology’ that automatically separates plasma and blood cells from a single drop of blood without special equipment such as a centrifuge," and "the complex analysis process is fully automated, so users only need to inject a drop of blood collected from the fingertip to obtain blood test results within 10 to 20 minutes."

A Syswork official said, "MARK-B precisely detects biomarkers of various severe diseases and shows quantified values, making it effective for early diagnosis and prognosis management of patients."

Choi Jaegyu, CEO of BBB, stated, "European certification (CE-IVD) is also valid in Middle Eastern, African, and Southeast Asian countries outside Europe, so it has great business significance," and explained, "We plan to expand competitiveness in the European market with the differentiated performance unique to MARK-B and use it as a foothold for full-scale sales expansion."

He added, "We expect the domestic and international certifications for cartridges for tumor marker tests, cardiovascular disease tests, and thyroid disease tests to be completed sequentially."