Breast Cancer Early Detection Blood Test 'MASTOCHECKTM'Expands to 7 Countries in Saudi Arabia and the Middle East - Bertis Signs Co-promotion and Distributorship Agreement for MASTOCHECKTM with SaudiVax During the State Visit of the President of South Korea to Saudi Arabia-CEO Seung-Man Han stated, "Due to the high demand for the blood test method and the presence of a nationally led medical delivery system in the region, we are committed to establishing a stable testing delivery system." On October 30th, 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 it has entered into a co-promotion and distributorship agreement for its early breast cancer detection blood test, MASTOCHECKTM, with the Saudi biotechnology firm, SaudiVax Inc., in Saudi Arabia.Through this agreement, SaudiVax will be responsible for sales and marketing of MASTOCHECK in seven countries, including Saudi Arabia, Bahrain, Kuwait. They will also manage the collection and delivery of blood samples for testing in medical institutions within those countries. Bertis will conduct the samples analysis and deliver the test results. Additionally, Bertis will provide necessary support for MASTOCHECK sales and marketing, including handling regulatory approvals, marketing, medical staff training, and patient information dissemination. In addition, this agreement was signed on the occasion of the state visit of the President of South Korea to Saudi Arabia from the 21st to the 24th, as well as the visit of the South Korean business delegation. Through this agreement, the two parties have agreed to simultaneously launch Bertis' developed products, including blood tests for early detection of pancreatic cancer, in seven Middle Eastern countries alongside their domestic commercialization. SaudiVax is a joint venture between a Saudi Arabian healthcare company UYC, and U.S.-based PnuVax, which supplies biologics to the Gulf Cooperation Council (GCC) and countries within the Organization of Islamic Cooperation (OIC). Furthermore, the company is actively supporting the Saudi Vision 2030 project, a comprehensive initiative led by Crown Prince Mohammed bin Salman aimed at economic diversification, global engagement, and enhanced quality of life. The company is dedicated to fostering the establishment of the life sciences industry within Saudi Arabia as part of this broader effort.Dr. Mazen Hassanain, co-founder and managing director of SaudiVax, stated, "Blood-based cancer screening tests are considered advanced technology that aligns with Saudi Arabia's goals in the health sector, including improving healthcare accessibility, through the Saudi Vision 2030 project. It is expected to contribute to the enhancement of public health and the development of biotechnology” he added, “We are committed to making our best efforts to facilitate the introduction of MASTOCHECK based on our supply system and expertise, ensuring that patients in need of MASTOCHECK can undergo testing smoothly."Seung-Man Han, the CEO of Bertis, stated, “Due to the gap in medical services accessibility among regions and factors related to religious and cultural differences, there is a high demand for early blood-based cancer diagnostic tests in key Middle Eastern countries. Introducing MASTOCHECK to these countries is a positive step forward.” He further mentioned, “As these countries take the lead in providing medical services, we expect the testing process to be activated rapidly from the early stages. We are going to put the best effort to establish a stable testing delivery system to ensure reliable test services for the patients.”MASTOCHECK is a blood test method that allows for convenient early screening of breast cancer. It quantitatively measures three specific protein biomarkers closely associated with breast cancer within the blood. The quantified biomarkers’ values are then analyzed using a patented proprietary algorithm to enable early detection of breast cancer. Bertis is currently developing early screening blood tests for pancreatic cancer and ovarian cancer as part of their follow-up pipeline. For pancreatic cancer early diagnostic solution, the product development has been completed including marker panels, algorithms, IVD software, and reagents. Currently the product is going through confirmatory clinical trial. Regarding ovarian cancer, the marker panel development has been completed and are planning clinical trials for algorithm enhancement.

BERTIS Joins 2023 Pink Festival of Pink Ribbon Campaign - In celebration of the Breast Cancer Awareness month in October, Bertis serves as a sponsor of the event to raise awareness of early detection and regular check-up of the disease. [Image] 2023 Pink Festival logo, Bertis logo Bertis, a company specializing in the development of proteomics-based precision medicine technology company (led by CEOs Dong-young Noh and Seung-man Han), announced on October 13th that it will participate in the 2023 Pink Festival at the Officers’ Quarters 5 in Yongsan on October 15th, to promote awareness of early detection and regular checkup of breast cancer. Marking its 23rd year, the Pink Festival is hosted by the Korea Breast Cancer Foundation, Korean Cancer Society, Korean Breast Cancer Society as part of the Pink Ribbon Campaign to raise awareness about a healthy lifestyle for breast health and breast cancer prevention. This year’s event will offer five fitness programs helpful for women’s health and breast health, such as Dance Fit, Piloxing, Pound Fit, Latin Fit and a 3km group run, approximately 1,000 people selected through pre-registration will participate. In celebration of Breast Cancer Awareness Month in October, Bertis will sponsor the 2023 Pink Festival and operate a promotional booth at the event. Along with hosting a quiz to help the participants understand the importance of regular breast checkups for early breast cancer detection, Bertis will provide essential information for regular breast cancer screenings, including an introduction of MASTOCHECK®, a blood test solution for early breast cancer diagnosis. MASTOCHECK® is the world’s first proteomics-based blood test solution for early breast cancer detection developed by Bertis. With its effectiveness in diagnosing stage 0-2 breast cancer has been verified in Korea, leading to its approval as an in vitro diagnostic medical device by the Ministry of Food and Drug Safety in 2019. As of October 2023, it is utilized by as many as 392 hospitals and health examination centers in Korea. Bertis CEO Seungman Han said, “As a company that offers a solution for early breast cancer detection and takes a leading role in promoting breast health awareness, our participation in this event is of great significance. While we concentrate on developing technologies essential for precision medicine, targeting major diseases, including breast cancer, we are committed to enhancing public awareness that the early detection and regular checkups.”

Bertis to Present 10 Research Outcomes at HUPO 2023,Including Development of Next-generation Analysis Methodfor Proteomic Data- HUPO, one of the world's largest proteomics societies, is returning to Korea for the first time in 16 years to be held at BEXCO, Busan from September 17 to 21- Bertis joins as a major sponsor in the event which attracts over 1,000 scholars and key industry officials from 40 countries- Bertis presents 10 studies, including the development of next-generation mass spectrometry and single-cell proteomic analysis, and highlights its core technology framework, ‘ProteoID’, as well as nine essential technologiesBertis, a company specializing in the development of proteomics-based precision medicine technology (led by CEOs Dong-young Noh and Seung-man Han), announced on September 7 that it would participate in ‘2023 HUPO, Human Proteome Organization’, one of the largest international academic gatherings in the field of proteomics. The event will take place from September 17 to 21 in Busan, Korea.HUPO 2023, themed 'Together Through Proteomics,' is scheduled to be held at BEXCO in Busan. The event is expected to draw over 1,000 researchers and prominent figures from more than 40 countries. This annual event, inaugurated in France in 2002, has been held continuously, rotating through the Americas, Asia, Oceania, Europe, and Africa. It now returns to Korea after 16 years since its last appearance in Seoul in 2007During the event, Bertis will deliver presentations on 10 studies, including the development of next-generation mass spectrometry and single-cell proteomic analysis methodologies. The three main topics Bertis will cover in oral presentations are ▲ Broad Target Scanning (BTS) - a pragmatic LC-MS acquisition method for collecting population-scale real-world proteomics data ▲ Identification of Secreted Unannotated Small ORF Microproteins from Adipocytes and in Plasma to Elucidate Function of Novel Gene Product Proteins ▲ Spatial proteomic approaches for triple-negative breast cancer on single-cell resolution. In addition, the company will provide seven poster presentations on DeepMRM: Deep learning-based object detection model for proteomics data, Exploring the Human Aging Blood Proteome, and others. <Image> List of Bertis’ oral presentations to be delivered at HUPO 2023(See the overview of presentation details below)Seung-man Han, CEO of Bertis, said, “It is encouraging for the Korean proteomics industry and academia that the representative academic event in the proteomics field is held in Korea at this critical juncture when the use cases of proteomics technology are rapidly increasing across all areas of the bio industry. Bertis will also leverage the upcoming HUPO 2023 as an opportunity to introduce Korea's technologies to the global proteomics community and make its utmost efforts to contribute to substantial breakthroughs in the development of proteomics technology.Bertis plans to focus on promoting protein data analysis and interpretation capabilities, as well as know-how in technological commercialization through HUPO 2023. The company will set up a large promotional booth inside the conference hall to introduce nine core technologies related to biomarker discovery and algorithm development, diagnostic service commercialization, and advanced technology. The primary focus will be on the core technology framework ‘ProteoID(Proteome Integrated Determination)’. Furthermore, it will publicize its pipeline of multi-marker solutions for early diagnosis, including ‘MASTOCHECK®’, an early diagnosis blood test for breast cancer, and PASS (Pan-omics Analysis Service & Solution). <Image> ProteoID, Bertis’ core technology system, and nine essential technologiesThe name ProteoID is derived from the term 'proteoid roots,' which refers to the densely packed roots of plants. It implies the interactions among proteins, combinations of various disease markers, and the organic blend of proteomics technologies. Bertis is fully committed to realizing the potential of proteomics in clinical and medical contexts based on ProteoID, a technology system that encompasses all stages of utilizing proteomics technology, from protein data analysis to product and service commercialization.

Bertis Pan-omics Analysis Solution and Systems (PASS) launched in the U.S.- Bertis, Inc.’s wholly owned US subsidiary, Bertis Bioscience, signed its first service agreement with the world-renowned Salk Institute for Biological Studies, to provide a PASS service using its CLIA lab and proteomics experts in San Diego, California.- In Korea, Bertis, Inc., already launched PASS in May 2022, offering a robust suite of analytical services including protein identifications, biomarker discovery and drug target discovery analytical services.Bertis (Co-CEOs Dong-Young Noh and Seung-Man Han), a proteomics-based precision medicine company announced the launch of PASS (Pan-omics Analysis Service) service in the United States through its wholly owned US subsidiary, Bertis Bioscience Inc.Pan-omics is the integration of complex “omics” datasets generated from the subfields of genomics, transcriptomics, proteomics and metabolomics to increase the understanding of pathophysiology, diagnosis and treatment of diseases. PASS is an insightful analysis solution leveraging Bertis’ pan-omics knowledge and know-how coupled with its proprietary bioinformatics and AI technology to deliver analytical services including the core protein identification and biomarker discovery but also drug development and clinical research processes.<Image> PASS LogoIn the US, Bertis’ wholly owned US subsidiary, Bertis Bioscience, has launched the much-anticipated PASS services after more than a year of preparation to assemble industry recognized experts in both mass spec-based proteomics as well as bioinformatics. The US PASS services will be provided at its CLIA Lab in San Diego. As part of the US PASS offerings, Bertis Bioscience will initially offer proof-of-principle studies for protein biomarker discovery using Seer’s proteograph and nanoparticle kits.On June 8, 2023, Bertis Biosciences signed its first proteomics-based analysis service agreement in the United States with the Salk Institute for Biological Studies, a San Diego-based non-profit life science research center. The Salk Institute is known for life-changing discoveries in the fields of cancer, neuroscience, aging, immunobiology, and plant biology. Six Nobel Prize winners conducted research at Salk, one of the world's leading research centers. Under this agreement, Bertis Bioscience will provide proteomic data analysis to look for novel human disease biomarkers.Han Seung-man, CEO of Bertis, said, "We are pleased with the market’s enthusiastic reception of our PASS service launched just last year. We attribute the success to the market’s recognition of Bertis’ proprietary technology and know-how in proteomics analysis and commercialization. Our technology and services have shown strong global competitiveness and receive favorable reception at various international conferences. We believe the US will provide a stage for us to showcase our expertise globally and build our PASS business by serving world-class research institutions as a start.”Amid the increasing demand for multiomics analysis data, PASS has received significant attention from industries such as biotech, pharmaceutical companies, and research institutes since its launch in Korea in May 2022. Leveraging its state-of-the-art analysis system and industry leading proteomics expertise, as of June, Bertis Inc. signed agreements for PASS with twenty companies, including national institutions, government-funded research institutes, and private companies.

Bertis Publishes Findings on ‘DeepMRM’, a Targeted ProteomicsData Interpretation Software Package in International Journal-Publish findings on assessing the performance and accuracy of the self-developed ‘DeepMRM’ in ‘Cell Reports Methods’, an international journal, on July 12-According to the results of the comparative test on the performance of discovering protein candidates, DeepMRM has higher accuracy than existing software and has the lowest error percentage-Promote high-speed analysis in the clinical environment and improve reproducibility and scalability of targeted proteomics analysisOn July 12, 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 it had presented its findings on assessing the performance of ‘DeepMRM’, a software package based on deep learning algorithms for object detection, in ‘Cell Reports Methods’.‘DeepMRM’ is a software package which the Bertis research team has developed by employing deep learning technology with the aim of more efficiently and accurately conducting MRM (Multiple Reaction Monitoring), a representative analysis method for discovering targeted protein candidates. With an existing community standard tool for MRM, researchers often devote substantial time to manual data interpretation, which hinders the transferability, reproducibility, and scalability of this approach. Deep MRM addresses these limitations by utilizing deep learning technology for object detection.The Bertis Machine Learning team and its U.S. subsidiary Bertis Bioscience team utilized public MRM dataset to test the performance of DeepMRM against the most widely used Skyline. The results demonstrated that DeepMRM outperformed Skyline in both correlation coefficient between quantification values and actual values of analyzed proteomes, and MAAPE (Mean Arctangent Absolute Percentage Error), which measures average error values. Even when applying the mProphet algorithm, a filter that allows skyline to make the results more refined, DeepMRM's results were more accurate.><Image: Table comparing the performances of DeepMRM and existing software>With its superior performance, DeepMRM not only reduces proteomic analysis time in clinical research, but also improves the reproducibility of analysis results, increasing the reliability of results. In addition, thanks to its high scalability, DeepMRM can analyze other types of proteins, such as PRM (ParallelReaction Monitoring) and DIA (Data-Independent Acquisition) data, in addition to MRM data.<Image: Process for analyzing targeted proteomics using DeepMRM>Jungkap Park, Director of Machine Learning team at Bertis, said, “DeepMRM is an innovative analysis tool that can dramatically increase data throughput in Bertis' major research areas - multi-biomarker diagnostic solutions and analysis services. Bertis will continue its R&D efforts towards AI-powered analytical tools to develop a unique platform which enables the diagnosis and treatment of diseases and the discovery of targeted candidates for new drugs in the future.”Seung-man Han, CEO of Bertis, said, “In our attempts to overcome the limits of proteomics data interpretation by integrating bioinformatics and AI technologies with proteomics technology, the publication of a paper on DeepMRM holds great significance. As a leader in proteomics in Asia, Bertis will spare no efforts in developing innovative technologies that can fully unlock the potential of proteomics in R&D and actual clinical applications.”Bertis is devoting itself to a project to eliminate limitations on interpreting and using proteomics data by incorporating proteomics technology accumulated over 10 years with bioinformatics and AI technologies. In particular, the company is making R&D efforts for the SAN (Spectrum is All you Need) model with a view to developing an innovative health information interpretation model which can produce health information from proteomic biometric information by automating the information processing and interpretation process.

Bertis Publishes Findings on 9 Protein Biomarkers andAlgorithm-based Test Model for Breast Cancer Early Detectionin International Journal- Propose a test model with AUC 0.9105 using 9 proteins as multiple biomarkers for breast cancer in stages 0-2- Develop an innovative platform for discovering and validating disease biomarkers based on its self-constructed quantifiable peptide libraryOn June 21st, Bertis, a company specializing in the development of proteomics-based precision medicine technology (led by CEOs Dong-young Noh and Seung-man Han), presented its findings on developing a nine types of protein biomarkers blood test for early diagnosis of breast cancer using its library for quantitative analysis of proteins and artificial intelligence (AI) technology.Through this research, designed to develop an advanced blood test for breast cancer diagnosis, the Bertis research team combined the quantitative values of 9 protein biomarkers to present a diagnostic test model with an average AUC[1] 0.9105 for stages 0-2 breast cancer, which is an improvement from that of ‘MASTOCHECK®,’ the world’s first proteomics-based blood test for early diagnosis of breast cancer developed and commercialized by Bertis.The research also revealed a platform for discovering and validating biomarkers that can drastically reduce time and cost in developing the proteomics-based diagnostic test. It uses 'PepQuant libraryTM', a library for quantifiable protein analysis developed by Bertis, which enables the discovery of biomarkers in the setting of a validation process. Instead of the existing difficult and expensive biomarker discovery method, this method uses the data pool of the library to perform discovery and validation together, saving time and cost and enabling a system that is easy to apply in the actual clinical environment.<Image>a. AUC to predict breast cancer b. Predicted Probability of 9 biomarkers for early diagnosis of breast cancer and deep learning algorithm(Normal, Stages 0-1, Stages 2-3, Other cancer (ovarian cancer, thyroid cancer, lung cancer, colon cancer and pancreatic cancer)The research team generated the library that is composed of 852 quantifiable peptides that cover 452 human blood proteins, and then selected and presented 9 proteins from them as biomarkers for breast cancer screening. The team also developed an algorithm for early screening of breast cancer using its deep learning technology specialized in simultaneous multiple analysis of proteins. The study was published in ‘Scientific Reports’ on June 2nd.Sungsoo Kim, Head of Bio Manufacturing subdivision, who led the research said, “These findings hold significance in that they show improved performance over MASTOCHECK®, which is currently commercially available, in screening for breast cancer. They also present an analysis platform that can be applied not only to breast cancer but also to various other diseases through the library.” He added, "Based on the results, Bertis will spare no efforts in future research and development to provide improved diagnostic tests to the medical field."Seung-man Han, CEO of Bertis, said, “This study has established an efficient biomarker discovery and validation system for the development of proteomics-based simultaneous multiple testing based on quantifiable proteins library and AI technology. Therefore, we expect that the introduction of innovative tests into the medical field will gain momentum.”Bertis is devoting itself to discovering biomarkers for major diseases and developing clinical solutions by incorporating proteomics technology accumulated over 10 years with the latest bioinformatics and AI technologies. The company has succeeded in commercializing proteomics technology through MASTOCHECK®, the world's first proteomics-based blood test solution for early breast cancer diagnosis, and PASS (Pan-omics Analysis Service & Solution), a pan-omics integrated analysis solution. It is also spurring its R&D efforts for early diagnosis solutions for various cancers, including pancreatic cancer and ovarian cancer, and analysis of blood proteomics with age.

Bertis Becomes a Member of the HUPO IAB- Bertis joined the IAB of the most prestigious society in the field of proteomics to serve as an advisor in collaboration with other representative global proteomics companies.- CEO Seung-man Han said, “Through this participation, Bertis will seek to contribute to the success of the HUPO 2023 set to be held in Busan this coming September and strengthen global cooperation. Furthermore, as a leader in proteomics in Asia, we will actively communicate and cooperate with global leaders.”Human Proteome Organization’s logo (left) and Bertis’ company logo (right)Bertis, a proteomics-based precision medicine technology development company (CEOs Dong-young Noh, Seung-man Han), announced on 18 that it had become a member of the Industrial Advisory Board (IAB) of the Human Proteome Organization (HUPO), the most influential academic organization in proteomics.Founded in 2001, HUPO is a 501 (c) 3 non-profit organization registered in the State of New Mexico and is the largest non-profit international scientific organization in the field of proteomics that studies the human proteome. As of May 2023, with 796 active members, HUPO represents and promotes proteomics through international cooperation and collaborations and by fostering the development of new technologies, techniques, and training.The IAB provides valuable input on technology and product innovation to the HUPO Council and its Executive Committee for the benefit of members and identifies industry trends that will position HUPO to meet the future challenges of its partners and organization. The IAB consists of companies in the proteomics industry, with a total of 21 global leading participants in proteomics companies focused on molecular analysis, equipment manufacturing, and diagnostic reagents, etc., as of May 2023.Chief Technology Officer Sangtae Kim, an expert in the field of bioinformatics related to proteomics, at Bertis Bioscience, an American subsidiary of Bertis, and Chief Strategy Officer Hyojung Park at Bertis will work as advisory committee members on the IAB.HUPO is scheduled to hold HUPO 2023, the world's largest academic event in proteomics, from September 17 to 21 at BEXCO in Busan. This event will offer educational and networking opportunities, together with presentations of remarkable findings in proteomics and lectures by renowned speakers and is expected to attract approximately 1000 attendees from 40 countries across the globe.Khatereh Motamedchaboki, Chair of the IAB, noted, “We are excited to welcome Bertis, a leader in the development and clinical application of proteomics technology in Asia, as a new member of our IAB with the coming of HUPO 2023 in Korea. We expect this new addition will facilitate communication and input between industry partners and supports industry allies active in the development of innovative technologies that are responsive to the constant changes in the scientific proteomics environment.Seung-man Han, CEO of Bertis, said, “We agreed to participate in the IAB to support the success of the HUPO 2023 to be held in Busan in September this year, and to enhance cooperation with global leading organizations by entering Southeast Asia and the United States markets. As the need for the employment of proteomics technology to tackle major human health problems through early diagnosis and customized treatment is soaring, Bertis intends to actively communicate and cooperate with global leaders as a leading Asian proteomics company.”Based on its expertise in proteomics technology accumulated over 10 years, Bertis has commercialized MASTOCHECK®, a blood test for early diagnosis of breast cancer, and PASS (Pan-omics Analysis Service & Solution) service, an integrated analysis solution for pan-omics (multi-dimensional-omics). In relation to the company’s overseas expansion, MASTOCHECK® has been exported and is being used in more than 40 locations in Singapore. In addition, it established Bertis Bioscience, an American subsidiary, in October 2021, and opened a laboratory in San Diego in April 2022.

Bertis Releases Two Academic Findings at 11th AOHUPOIncluding Systematic Analysis of Blood Proteome across LifespanBertis will present two posters on the analysis of the blood proteome across the lifespan and the discovery of specific biomarkers for ovarian cancer in Singapore from May 8th to 10th.On May 8th, 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 it will present two research findings at the 11th Asia Oceania Human Proteome Organization (AOHUPO) conference, held at the Singapore EXPO from May 8th to 10th.The findings will be presented as a poster at the symposium, which will cover the systematic analysis of the blood proteome across the lifespan and the development of a serum biomarker panel for the diagnosis of high-grade serous ovarian cancer by global and targeted proteomics.<Image: Expression patterns of 1,233 blood proteins in aging>With respect to the analysis of blood proteome analysis across the lifespan, the Bertis research team analyzed the blood samples of 337 healthy individuals aged between 20 and 85 to verify changes in blood proteome due to aging. The presentation will showcase the first research achievement from the relevant study. According to the research results, proteins up- regulated during aging were mainly involved in immunity and inflammatory response while proteins down-regulated during aging were involved in cell proliferation, angiogenesis, and metabolism. Furthermore, 1,233 circulating proteins were found to show major aging expression patterns, suggesting that they can serve as an 'aging clock', which is based on the notion of measuring human biological age.To discover protein biomarkers for early diagnosis of high-grade serous ovarian cancer (HGSOC), the Bertis research team identified 1,847 proteins and validated 18 biomarker candidates, the results of which were published in the international journal 'Journal of Proteome Research' last September. The company has completed the development of the algorithm with 95% accuracy (100% sensitivity and 91% specificity) for stages 1-3 HGSOC through multi-marker-based analysis and now the verification of the algorithm is underway.Un-beom Kang, Head of Bertis Biomarker Research Institute, said, "We are excited to present the result of our technological advancements in the in-depth analysis of blood proteome at one of the most prominent academic conferences in Asia and Oceania. Bertis will continue to dedicate itself to future R&D to address unmet clinical needs based on these findings."Bertis currently possesses world-class mass spectrometry-based quantitative proteomics technology and has successfully commercialized MASTOCHECK®, the world's first regulatory-approved proteomics-based blood assay for early breast cancer detection as well as PASS(Pan-Omics Analysis Service & Solution), a platform for the integrative analysis of pan-omics(multi-omics) data. Recently, Bertis has been striving to overcome challenges in interpreting and utilizing proteomics data with the help of bioinformatics and AI.

Bertis Announces Research Results on Prognosis Observation of Breast Cancer Surgery including Recurrence Diagnosis Using Mastocheck®- Published the study results analyzing the usefulness of Mastocheck® and the performance of diagnosing local recurrence in observing the prognosis of patients undergoing breast cancer surgery in the international journal ‘Journal of Cancer Research and Clinical Oncology’- Showed higher sensitivity than the existing single biomarker CA15-3 test in patients more than 1 year after surgery, with respect to local recurrenceBertis, a proteomics-based precision medicine technology development company (CEOs Dong-young Noh and Seung-man Han), announced the results of a study evaluating the utilization of Mastocheck® in observing the prognosis of patients undergoing breast cancer surgery on January 19, 2023.Mastocheck® is a convenient technique that screens for the presence of breast cancer through patented algorithmic calculations of three plasma protein levels specific to breast cancer. This solution proved its effectiveness in diagnosing stage 0 to 2 breast cancer and its approval as a medical device for In Vitro diagnosis was obtained from the Ministry of Food and Drug Safety in 2019and after being selected as a Conditional Approval System of Health Technology (The conditional approval scheme for highly needed medical devices) in 2022. The solution has been used as an early breast cancer diagnosis test at health examination centers and hospitals.The study results verified the potential of Mastocheck®, which is useful for prognosis management after breast cancer surgery, including early diagnosis of local recurrence. The research paper was published in the international journal ‘Journal of Cancer Research and Clinical Oncology’last December.The study was conducted with two cohorts of a total of 255 breast cancer patient groups, with the aim of confirming the effectiveness of Mastocheck® in managing the prognosis of patients who underwent breast cancer surgery and assessing its performance in the early diagnosis of local recurrence.For the first cohort, changes in Mastocheck® values were analyzed for the regular follow-up periods which span from the breast cancer diagnosis (prior to the surgery) to after the surgery. The results of Mastocheck® decreased significantly over time after surgery compared to before the surgery (p<0.001), indicating a non-cancerous healthy condition according to Mastocheck® criteria. Of 111 patients in the cohort, two blood analyses were performed on 108 patients and three analyses were performed on 53 patients. Mastocheck value was within the normal range (result value, <0.0668) in 68.5% (in 74 of 108 patients) at 8 weeks after the surgery and in 88.7% (in 47 of 53 patients) at 6 months to 1 year after the surgery.The assessment of the diagnosis of local recurrence after breast cancer surgery was conducted in cohorts of patients who had undergone the surgery more than a year ago. In the study, both Mastocheck® and as a control, CA15-3, the single biomarker blood test which has been used for recurrence follow-up after surgery, were performed on all patients, divided into patients with confirmed recurrence and patients without recurrence (i.e., healthy patients)According to this cohort analysis, the diagnostic accuracy of Mastocheck® for local recurrence was 71.5% (sensitivity 60.3%, specificity 80.2%). In contrast, CA15-3 test results performed on relapsed patients showed that 98.4% of relapsed patients enrolled in the study were within the normal range, indicating that Mastocheck® outperformed CA15-3 in diagnosing local recurrence.“It is important to detect early recurrence in post-surgery management of breast cancer, and more advanced diagnosis options are needed in the medical field,” said Professor Yumi Kim of the Department of Surgery at CHA Gangnam Medical Center, CHA University, who led this study. She added, “Since this study verified the possibility of using multi-biomarker-based blood tests for prognosis management of breast cancer surgery patients, including early diagnosis of local recurrence, we plan to continue examining the usefulness of the test through clinical studies.”Mastocheck® can be used as a non-reimbursable treatment for suspected breast cancer patients, as it was designated as a Conditional Approval System of Health Technology in June 2022 and has been introduced to around 300 domestic hospitals and health check-up centers. This solution has also been introduced to Raffles Medical Group, Singapore's large-scale private medical groups, and Solis Breast Care & Surgery Centre, a specialized hospital for breast health and is used by more than 40 medical institutions for diagnosis.