KPS Receives IRB Approval for Early Liver Cancer Diagnosis Kit... "Product Development to Begin in Q1 Next Year"

[Asia Economy Reporter Jang Hyowon] KPS Bio Division is accelerating the development of an early diagnosis kit for liver cancer, for which it holds global rights. The company plans to start new product development as early as the first quarter (January to March) of next year.

On the 7th, KPS announced that it recently received IRB (Institutional Review Board) approval from Korea University Guro Hospital to study the usefulness of markers for liver cancer screening.

Going forward, the company plans to collaborate with the hospital’s Department of Laboratory Medicine (Professor Yoon Sooyoung), Department of Gastroenterology (Professor Kim Jihoon), and the G-Valley Medical Device Development Support Center (GMSC) to verify the clinical utility of liver cancer markers and begin product commercialization early next year.

At the end of last year, KPS signed a license-in agreement for liver cancer diagnostic biomarker technology from Neonaro, a developer of RNA (ribonucleic acid) targeted anticancer drugs. They secured global rights to early diagnosis technology for liver cancer using multiple specific markers such as 'HMMR', 'NXPH4', 'PITX1', 'THBS4', and 'UBE2T'.

According to research by Neonaro, a researcher-led clinical trial using 2 to 3 multiple markers as indicators was conducted on 86 healthy individuals and 132 liver cancer patients, showing sensitivity (patient detection rate) and specificity (normal detection rate) both close to 99%. This performance greatly exceeds that of the existing single liver cancer diagnostic marker, serum alpha-fetoprotein test (AFP), which has a sensitivity of about 66% and specificity of 82%.

Liver cancer is diagnosed as advanced liver cancer (local and distant) in 54.3% of cases at diagnosis, with a 5-year survival rate of 2.8% to 22.4%. In contrast, early diagnosis raises the 5-year survival rate to 60.7%. Early diagnosis is therefore a very important factor in extending survival rates.

To accelerate product commercialization, Director Mok Rakseon, known as an expert in mass production lines for in vitro diagnostics, has also joined KPS. Director Mok has marketed over 20 products in the fields of immunodiagnostics and clinical chemistry diagnostics over 23 years, and has extensive experience from diagnostic kit development to production processes through roles at Boditech Med R&D Center, Digital Optic BIT Division Headquarters, and Youngdong Pharmaceutical R&D Center.

Director Mok said, "If the verification clinical results are positive, we will start product development immediately from next year," adding, "We will produce an early diagnosis product superior to the existing liver cancer biomarker (AFP) performance and provide new treatment options to high-risk liver cancer patients."

Meanwhile, according to the global market research firm IndustryARC, the total market size for the single liver cancer marker AFP is expected to grow at an average annual rate of 5.3%, from about 6.5 trillion KRW this year to 9 trillion KRW by 2027.

This content was produced with the assistance of AI translation services.