KPS Bio Division announced on the 4th that the early liver cancer diagnostic biomarker, for which it holds worldwide rights, was validated through clinical trials conducted at Korea University Guro Hospital, and was analyzed to have outperformed the existing single liver cancer biomarker (AFP).
KPS plans to enter the productization phase starting with additional patent applications for specific biomarkers and underlying technologies within this year.
According to KPS, in this clinical trial conducted on healthy group (45 people), liver disease group (35 people), and liver cancer group (27 people) by combining specific liver cancer biomarkers they possess?‘HMMR’, ‘NXPH4’, ‘PITX1’, ‘THBS4’, and ‘UBE2T’?as multi-indicators, the usefulness of the candidate combination was confirmed, revealing the optimal biomarker combination including serum alpha-fetoprotein test (AFP).
The sensitivity (rate of liver cancer detection) and specificity (rate of normal detection) were analyzed as 92.6% and 78.8%, respectively, significantly surpassing the current single liver cancer diagnostic marker AFP’s sensitivity (about 66%) and specificity (about 82%).
Director Mok Rak-seon stated, "Especially in the analysis distinguishing early-stage liver cancer (stages 1 and 2) and advanced liver cancer (stage 3 and above), 17 out of 19 early liver cancer cases were identified as liver cancer (sensitivity 89.5%), which is very encouraging," adding, "For advanced liver cancer cases, a 100% sensitivity was shown, indicating it can be actively utilized for liver cancer screening."
According to the global market research firm MMR (Maximize Market Research), the global liver cancer AFP diagnostic market is expected to reach approximately 1.3 trillion KRW by 2027. Among this, the global big five (Roche, Abbott, Beckman, etc.) are projected to hold a market share of 85%.
Regarding this, Director Mok said, "From the early stages of productization, we plan to establish partnerships with global diagnostic companies and develop concrete sales strategies," and added, "Even supplying these companies in the form of semi-finished products (ODM) could generate annual sales of about 500 billion KRW, including the domestic market."
He further added, "We will immediately proceed with patent applications for biomarker and conditional algorithm technologies, as well as specificity improvement work (additional clinical trials) to secure statistical significance."
Meanwhile, KPS had previously signed a technology transfer (license-in) agreement for liver cancer diagnostic biomarker technology from RNA-targeted anticancer drug developer Neonaro, and since receiving IRB (Institutional Review Board) approval from Korea University Guro Hospital in December last year, has been verifying clinical utility.
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