OVCHECK have secured a marker that can diagnose ovarian cancer with an accuracy of 95% or higher (sensitivity of 100% and specificity of 91%), and the project is currently in the clinical validation stage. OVCHECK DEVELOPMENT PROCESS Bertis is currently developing a highly accurate early ovarian cancer diagnosis technology with Seoul National University Hospital Gangnam Center. The tumor markers CA125 and HE4, the conventional biomarker for ovarian cancer testing, have limitations in the early screening of ovarian cancer due to their low sensitivity and specificity. Bertis is developing a technology that enables a more accurate diagnosis of ovarian cancer and is currently in the clinical verification stage by securing markers to diagnose ovarian cancer with more than 95% accuracy (100% sensitivity and 91% specificity).
PANCCHECK is a blood test solution that enables early diagnosis of pancreatic cancer with 94% accuracy is under development. PANCCHECK DEVELOPMENT PROCESS: While effective early diagnostic methods for pancreatic cancer are currently lacking, BERTIS is developing a technology that enables early diagnosis of pancreatic cancer with a small blood sample. Through research, we have identified 10 protein biomarkers as a diagnostic marker panel for pancreatic cancer. Following algorithm development and validation, we have uncovered a combination of markers that demonstrates a high accuracy of 98% and is applicable in clinical settings.
Global proteomics (Cell, Tissue, blood proteome) Label-free analysis based on data-independent acquisition (DIA). Our industry-leading protein analysis of non-depleted plasma can result in 1,300 protein identifications in one-hour per single sample. Our isotope-labeling enables a sample-to-sample comparison analysis in protein quanti�cation. Bertis labeling quantification and advanced fractionation technology enable industry-leading protein quantification analysis in cell or tissue samples. Our phospho/glyco proteomics ensures high-quality post-translational modification (PTM) analysis of proteins, providing an optimized solution for biomarker discovery and mechanism of action analysis. Our bioinformatics analysis provides your research needs from basic analysis of protein composition and quantiy cation to in-depth systems biology analysis. We provide analysis services that meet our customer's needs through continuous communication and interaction.
Companion Diagnostics (CDx) provide a companion diagnostic solution through pathway analysis based on RNA and protein quantification information respective to subtypes from each diseases. For precision medicines developed based on multi-omics analysis, biomarkers can be used to identify target patients in advance. Global pharmaceutical companies are active in the use of companion diagnostics as a key strategic tool in clinical development programs. PASS provides solutions for the entire process from discovery of drug candidates to non-clinical to clinical trials through pan-omics technology. Bertis has array of innovative and reliable technology to increase the safety and efficacy of an investigational drug across the clinical research landscape, including solutions for the discovery of biomarkers for companion diagnostics and the determination of clinical targets through functional analysis.
Protein Characterization (Physicochemical property of proteins) structure analysis using mass spectrometry provides results that meet the requirements of the FDA, the MFDS and other regulatory authorities regarding novel therapies or biosimilars. Based on basic amino acid analysis (full sequencing), we perform post-translational modification (PTM) analysis, which is important for protein potency and stability. In this regard, we can perform test methods based on design of experiment (DOE) statistical methodology and deliver documents to be submitted to regulatory authorities. Protein identification and quantification : Structural analysis of all types of protein therapeutics, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and enzymes - Full Length-Amino acids sequencing Peptide identification of each peak through peptide mapping (MS spectrum confirmation, MS/MS spectral analysis with 100% AA matches) - Improved N- and C-terminal sequencing of proteins Post-translational modification (PTM) : More reliable results based on design of experiment (DOE) statistical methodology to perform the experiments systematically and analyze data efficiently - Disulfide bond analysis ID Total possible lankage analysis - Deamidation identification and quantification - Phosphorylation identification and quantification , phospho-proteomic analysis - Other functional modifications Glycomics : Single protein analysis and research of protein complexes with glycosylation closely related to biological function and toxicity as well as structural stability of proteins - Glycosylation site determination - Glycan profiling - Site-specific glycan identification and quantification - Glycomics research with glycan enrichment
Proteomics-based Early diagnosis using multiple markers provides a quick and accurate solution for early diagnosis of major diseases by utilizing multiple proteomic biomarker-based blood tests. Early diagnostic solutions BERTIS has commercialized MASTOCHECK, the worlds first proteomics-based blood test solution for early diagnosis of breast cancer, and clinical trials are being conducted on biomarkers for various cancers. Ultimately, these technologies are being used to continually expand the pipeline to allow dozens of diseases to be diagnosed with a single blood test.
MastoCheck is a blood test that can easily screen for breast cancer at an early stage. Breast cancer is diagnosed early by substituting the quantitative values of three types of protein biomarkers in the blood, which are closely related to breast cancer, into a unique, patented algorithm. An innovative and convenient test method that detects early breast cancer with an accuracy of 92% (based on the patent) by using only a very small amount of blood. Bertis has developed multiple markers that can detect early breast cancer with an accuracy of 92% through identification of multiple proteins that are expressed sensitively in early-stage breast cancer and combination of certain proteins that demonstrated high accuracy and reproducibility among these combinations. DEVELOPMENT PROCESS: - MASTOCHECK was developed by a team led by Professor Dong-Young Noh, a world-renowned authority on breast cancer, of Seoul National University. - After analyzing approximately 600,000 proteins and selecting 3 markers exhibiting optimal accuracy, the highest accuracy was obtained by adding Bertis�¢?? own algorithm that enhances accuracy. - After several years of repeated validation work, a medical device product license was obtained from the MFDS in January 2019. To date (as of September 2023), MASTOCHECK has been introduced to about 400 hospitals and screening institutions nationwide, with priority given to large screening institutions.
Proteomics-based early diagnosis determines the presence of disease by identifying proteins that are specifically expressed in diseases and using these as biomarkers to measure the quantitative values of the relevant proteins in blood. Proteomics analysis has been assessed as highly likely to be used as a universal primary screening method because analysis can be performed even with trace samples, such as a few drops of blood. High diagnostic accuracy : Quantitative values of biomarkers are measured and entered in a unique algorithm with applied AI. Convenience : No burden of inconvenience caused due to the use of a separate diagnostic device other than blood sampling Efficiency: Provides diagnosis opportunities to more people in situations where personnel and devices are limited
Exo-PASS Exosomes contain proteins, lipids, nucleic acids, and metabolites, and can be easily enriched from biofluids, providing very valuable information for early detection and monitoring of diseases. The Ministry of Food and Drug Safety requires RNA, lipid and proteomic analyses in its guidelines for the development of exosome therapeutics, and PASS provides these analyses in an all-in-one package. Exosome RNA Sequencing: PASS enables rapid and efficient isolation of RNAs and profiling of exosome nucleic acids using qRT-PCR and novel sequencing methods. Exosome Lipidomics: We perform high-reliability and high-sensitivity analysis through an ultra-high-performance tool (UPLC, Orbitrap Exploris 480 MS) and lipid analysis experts who have been producing and interpreting analysis data for many years. Exosome Proteomics: PASS offers and performs quantification analysis that meets customer needs based on the unique expertise in exosome protein extraction. We provide reliable results through deep profiling of exosome proteome and a specialized data library. Our world-class bioinformatics research team at Bertis reviews and interprets pan-omics data (RNA/Lipid) to support in-depth research.
