Bertis
Presents Blood Test Model for Pancreatic Cancer Diagnosis with 92% Accuracy
Based on 13 Biomarkers-
Presenting an exploratory trial result for
early diagnosis of PDAC using LC-MS technology effective for disease screening-
Conducting a confirmatory trial for
pancreatic cancer’s early diagnosis blood test ‘Panccheck,’ having secured
blood samples from 513 individuals, including 220 pancreatic cancer patientsOn
September 24th, Bertis, a company specializing in the development of
proteomics-based precision medicine technology (led by CEOs Dong-young Noh and
Seung-man Han), announced that the findings on protein biomarkers for the
diagnosis of Pancreatic Ductal Adenocarcinoma (PDAC) were published in the
September issue of the prestigious international journal ‘Molecular &
Cellular Proteomics.’Pancreatic
cancer is highly lethal due to its asymptomatic nature in the early stages,
making early detection extremely challenging. Most
patients are diagnosed at advanced stages, resulting in very low survival
rates. According to data released by the Korea Central Cancer Registry in 2024,
the 5-year cancer relative survival rate for pancreatic cancer from 2017 to
2021 is only 15.9%, making it the most difficult to treat among the top 10
cancers. In particular, PDAC, which accounts
for more than 90% of pancreatic cancer, is considered one of the most lethal
cancer types with a 5-year average survival rate of less than 10%.Currently,
the blood biomarker Carbohydrate Antigen 19-9 (CA19-9) is used for pancreatic
cancer screening, but its usefulness is considered limited due to its low
positive predictive value. This
study focused on developing an effective diagnostic method for PDAC screening
based on Liquid Chromatography-Mass Spectrometry (LC-MS) technology, which
allows for the simultaneous and precise quantification of multiple protein
biomarkers in blood and is effective for disease screening tests that require
economical and rapid analysis of a large number of samples.In this
study, the Bertis research team selected 12 protein biomarkers that were
differentially expressed in PDAC patients compared to a control group of
healthy individuals and/or those with benign pancreatic diseases, using mass
spectrometry and bioinformatics techniques. They then developed a Multi-Marker
Panel consisting of 13 biomarkers combined with CA19-9. In the next step, they
developed a diagnostic test model with improved performance and robustness
using machine-learning technology and evaluated its diagnostic performance for
PDAC screening. As a result, the model demonstrated an accuracy of 92% for all
stages of PDAC and stage 1 to 2 PDAC, showing improved diagnostic performance
in all cases compared to when CA19-9 was used alone.Un-beom
Kang, Head of the Bertis Biomarker Research Institute and co-leader of the
research, stated, “The results of this study represent a significant
achievement in providing a useful diagnostic model for the early detection of
pancreatic cancer, a particularly hard-to-treat cancer, based on Bertis’
advanced technologies in proteomics, bioinformatics, and machine learning. We
are committed to follow-up research and development to ensure that healthcare
professionals and patients can utilize this technology in clinical settings,
thereby facilitating early diagnosis of pancreatic cancer.”Bertis is
promoting the commercialization of its blood test, Panccheck®, to aid in the
early diagnosis of pancreatic cancer based on this research achievement.
Currently, a confirmatory trial is underway, with blood samples secured from
513 individuals, including 220 pancreatic cancer patients, in preparation for
approval from the Ministry of Food and Drug Safety. Additionally, Bertis is
developing an early diagnosis test for ovarian cancer, which has the highest
mortality rate among gynecological cancers and lacks effective early detection
methods. The marker panel development is complete, and a clinical trial for
algorithm enhancement are planned.Seung-man
Han, CEO of Bertis, emphasized, “Bertis is working to introduce multi-marker
diagnostic solutions with improved accuracy based on more biomarkers for major
diseases by adding the latest machine learning technology to the proteomics
technology we have developed over the past decade. Building on our capability
to commercialize Mastocheck, the world’s first proteomics-based blood testing
for early breast cancer diagnosis, we are committed to providing effective
early diagnosis solutions for hard-to-treat diseases like pancreatic cancer in
clinical practice.”Meanwhile,
Bertis combines proteomics and bioinformatics to develop innovative biomarkers
for cancer and other major diseases, as well as provides diagnosis and analysis
solutions. It succeeded in commercializing proteomics technology with
Mastocheck®, the blood testing solution for early breast cancer diagnosis, and
PASS (Pan-omics Analysis Service & Solution), an omics analysis solution.
Bertis continues to conduct research on early diagnosis solutions for major
diseases.