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 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 recurrence  Bertis, 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 2019 and 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.

Mastocheck®, a blood test for early diagnosis of breast cancer, selected as a “2022 Next-Generation World Class Product”by the Korean Ministry of Trade, Industry, and Energy - Marketability and growth potential as the world’s first proteomics-based breast cancer early diagnosis blood test were recognized by the Korean Ministry of Trade, Industry and Energy’s World Class Product Development Review Committee- Several benefits were granted; certification logo for 3 years, additional points for application in support systems such as finance and consulting operated by related ministries and government agencies, benefit from preferential interest rates and limits, discounts and so on  On the 18th, CMO In-hoi Koo of Bertis attended the “2022 World Class Product Certificate Award Ceremony” held by the Korean Ministry of Trade, Industry and Energy at LOTTE Hotel in Jung-gu, Seoul, and received a “Next-Generation World Class Product” certificate. Proteomics-based technology and precision medicine development company Bertis (CEOs Dong-young Noh and Seung-man Han) announced on the 21st of November that Mastocheck®, a blood test for the early diagnosis of breast cancer, was selected as a “2022 Next-Generation World Class Product” certified by the Korean Ministry of Trade, Industry and Energy (hereinafter “MOTIE”). “Next-Generation World Class Products” are selected in recognition of the possibility that the product could rank top 5 or take 5% of the global market share within the next seven years after reviewing marketability and growth potential by the World Class Product Development Review Committee held by MOTIE, and after 3 years, a qualification examination is conducted on the product annually. Selected products are given the benefits of receiving a certification logo, and for finance, consulting, and overseas marketing, additional points for applications in the support system operated by relevant ministries and government agencies such as MOTIE and the Korea Trade-Investment Promotion Agency (KOTRA), preferential interest rates and limits, and discount benefits.  Mastocheck®, which was selected as a Next-Generation World Class Product this year, was developed by Bertis and is the world’s first proteomics-based early diagnostic blood test for breast cancer. The Mastocheck® has proven effective for diagnosing stage 0 to 2 breast cancer in Korea and it was approved as an in vitro diagnostic medical device by the Korean Ministry of Food and Drug Safety in 2019. In June of this year, the test was confirmed as an advanced medical technology by the Korea National Evidence-based Healthcare Collaborating Agency (NECA), enabling out-of-pocket use in outpatient settings. Currently, Mastocheck® is available in around 170 hospitals and health examination centers in Korea. Mastocheck® is expanding not only domestically in Korea, but also overseas. Recently, Bertis made a Mastocheck service agreement with Raffles Medical Group, the largest private medical group in Singapore, the Solis Breast Care & Surgery Center, and Innoquest Diagnostics, a medical consignment agency, and the test is being provided at more than 40 medical institutions in Singapore. About Mastocheck® being selected this year, Bertis CMO (Chief Marketing Officer) In-hoi Koo commented, “It’s incredibly meaningful that Mastocheck® was recognized for its potential for success in the global market as an innovative diagnostic solution in the first year of its overseas expansion,” and added that, “As the proteomics leader of Asia, we, at Bertis, will work hard to expand our presence overseas so that more people can experience the usefulness of proteomics technology in disease diagnosis.” Bertis focuses on researching and developing proteomics-based diagnostic solutions for several diseases such as pancreatic cancer, ovarian cancer, and so on, following breast cancer. Recently, the research team at Bertis presented a new multi-biomarker panel candidate with 95% accuracy for the diagnosis of stage 1 to 3 high-grade serous ovarian cancer (HGSOC), and the relevant paper was published in this year’s September issue of the Journal of Proteome Research.

Contracted with one of the largest medical groups in Singapore…Gained a foothold into the Asian marketBlood Based Early Breast Cancer Assay ‘Mastocheck’,Entry to APAC Region Starting with Singapore  - Contract signed regarding Mastocheck supply agreement with the one of the largest medical groups in Singapore, Raffles Medical Group (RMG), with future plans to distribute to RMG’s overseas medical facilities in China, Japan, Cambodia, and Vietnam- CEO of Bertis, Seungman Han mentioned, “Going to focus on expanding the overseas deployment, enabling many people to benefit from proteomic-based diagnostic solutions” Bertis (CEO Dongyoung Noh, Seungman Han), a proteomic-based precision medicine technology developing company, announced on 26 that Bertis has signed a contract with one of Singapore’s largest medical groups, Raffles Medical Group (RMG), to supply blood-based early breast cancer assay, Mastocheck. Through this contract, Mastocheck will be introduced at Raffles Breast Centre, Raffles Health Screeners, and over 30 Raffles Medical clinics in Singapore, with future plans to distribute to RMG’s overseas medical facilities in China, Japan, Cambodia, and Vietnam. RMG is a leading private healthcare provider in Asia, operating four hospitals and over 100 medical clinics across 14 cities in Asia. Established in 1976, RMG has over 2,700 employees and it provides a seamless and continuum of care to more than 2 million patients annually. ​< Medical Director of Raffles Medical Group, Dr. Chng Shih Kiat(Left) and CEO of Bertis, Seungman Han (Right) are taking a commemorative photo after signing a Mastocheck supply contract on Sept 26> Mastocheck is the world’s first blood-based early breast cancer assay using proteomics technology developed by Bertis. It diagnoses breast cancer by inputting the quantified values of breast cancer-specific protein biomarkers from the blood into a unique algorithm. Mastocheck was approved as an in vitro diagnostic device by the Ministry of Food and Drug Safety, known as KFDA in January 2019 after providing its efficacy in diagnosing stage 0-2 stage breast cancer. Asian women, including Koreans, have a higher proportion of dense breasts than Western women. In the case of dense breast, the density of mammary gland tissue is higher than that of adipose tissue, so the tumor may not be visible during the Breast X-ray, Mammography. Mastocheck is a blood-based assay that shows high accuracy even in dense breast women. Since blood-based assay does not depend on reader’s subjective judgment, it shows consistent and accurate result at all times. It also can apply to younger women, and pregnant women. CEO of Bertis, Seungman Han said “Proteomic technology has the advantage of providing accurate and convenient high-quality tests at an affordable price. And we will do our best to expand the Mastocheck availability to other regions, including Asia so that more people can benefit from the proteomic-based diagnostic assay.” Dr. Chng Shih Kiat, Medical Director of Raffles Medical said “Breast cancer is the most common cancer in women, and early detection can save lives. As part of our continued effort to improve patient care, Mastocheck is offered at Raffles Breast Centre, Raffles Health Screeners, and over 30 of our GP clinics to serve our patients’ evolving healthcare and wellness needs.” Bertis is also a representative company in the clinical proteomics field that successfully commercialized breast cancer assay by combining proteomics and bioinformatics. In October 2021, Bertis Bioscience, a U.S. corporation, was established and its San Diego laboratory was opened in April 2022.

Bertis announces breast cancer screening survey resultsahead of Breast Cancer Awareness MonthEight out of ten women responded, “breast cancer screening is necessary” - Bertis conducted a breast health awareness survey on 1,000 women in their 20s to ‘50s with the Korean Breast Cancer Society ahead of “Breast Cancer Awareness Month” in October.- Six out of ten women have experienced breast cancer screening through mammography, breast ultrasound, etc.- Reasons for discomfort during breast cancer screening include “pain” for mammography and “embarrassment” for breast ultrasound.- 91% of respondents said they are interested in undergoing breast cancer screening and blood tests. The key is a “simple and comfortable screening procedure."  On October 28, Bertis Inc. (co-CEOs Dong-young Noh and Seung-man Han), which has developed a proteomics-based early diagnosis technology, announced the results of a survey on the awareness of breast health. The survey was conducted on 1,000 women in their 20s to ‘50s in partnership with the Korean Breast Cancer Society (President Kim Gwon-cheon) ahead of “Breast Cancer Awareness Month” in October. According to the survey results, 48.8% of the respondents said they are worried about breast cancer and 83.6% responded that breast cancer screening is necessary, showing a social consensus on the importance of breast cancer screening. ■ 63.8% of women have undergone breast cancer screening. Some women feel uncomfortable during screening due to “pain,” “embarrassment,” and so on.The representative methods of breast cancer screening are mammography and breast ultrasound, which are imaging tests. Also, in this survey, six out of ten women said they had undergone breast cancer screening. Among respondents who had experienced breast cancer screening, 32.6 percent said they had mammography, 15.5 percent said they had a breast ultrasound, and 49.5% said they had both mammography and breast ultrasound. Meanwhile, to the question, “Have you ever felt uncomfortable during breast cancer screening?” 71.4% of respondents who had mammography and 42.6% of respondents who had a breast ultrasound answered that they had felt uncomfortable and burdened. As for the reasons for discomfort, in the case of mammography, pain (79.6%) took first place, followed by ▲ being embarrassed (47.7%), ▲ a concern of radiation exposure (36.1%), ▲ screening process (15.8%), and ▲ other reasons (1.4%). In the case of breast ultrasound, the reasons cited were ▲ being embarrassed (52.4%), ▲discomfort caused using ultrasonic gel (39.7%), ▲ screening price (33.5%), ▲ pain (21.4%), and ▲ long waiting time (19.2%), in that order. Regarding the reasons for not undergoing breast cancer screening, the respondents selected the following factors: ▲don’t feel the need (48.6%, 176 respondents), ▲ no recommendation from screening institutions (37%, 134 respondents), ▲ fear of screening (30.4%, 110 respondents), ▲ the burden of screening price (21.5%, 78 respondents), and ▲ being embarrassed (15.2%, 55 respondents). ■ Low awareness, high interest for breast cancer blood test Bertis also confirmed the need for new breast cancer screening methods, such as blood testing, through this survey. To the question, “Do you know about the breast cancer blood test?” only 10.3% of respondents said yes, suggesting that awareness of the screening method was low. However, most of the respondents had a positive reaction to the breast cancer blood test. To the question, “Do you intend to take a blood test for breast cancer screening?” 90.6% of respondents said they intended to take it in conjunction with existing breast cancer screening (mammography and breast ultrasound) while only 9.4% said they had no intention of taking the blood test. As for the advantages of breast cancer screening through a blood test, most of the respondents selected the simple comfortable test procedure (83.8%, 838 respondents). The respondents also picked ▲ short screening time (60.6%, 606 respondents), ▲ no concern of radiation exposure (60%, 600 respondents), ▲ no burden of pain (59.5%, 595 respondents), and ▲ not being embarrassed (54.9%, 549 respondents). ■ The survival rate for stage IV breast cancer is just 34%, so early detection is key.Given that the average life expectancy of a Korean woman is 83 years, one in 25 women will experience breast cancer in their lifetime. If the cancer is detected in stage 0 to II, the 5-year survival rate is as high as 90%. However, as the survival rate rapidly decreases to 34% in stage IV, experts stress that early detection of breast cancer is critical. Under these circumstances, Bertis has introduced “MASTOCHECK,” a blood test that enables the diagnosis of breast cancer in early stages, through major medical centers. MASTOCHECK is a screening method that detects early-stage breast cancer using a small amount of blood, only 1 ml, with 92% accuracy (based on the patent). It shows excellent screening efficacy even when used alone, but if it is used along with mammography, the sensitivity (positive detection rate) increases to a very high level. It boasts excellent safety and convenience in that it can detect breast cancer by simply using the blood of patients, without the risk of radiation exposure. “Early detection of breast cancer can increase quality of life after treatment through breast conservation and a fast recovery during the treatment process. As many cancers diagnostic technologies have recently been developed, there are a variety of choices for breast cancer screening, such as blood tests that can be used with existing breast cancer screening techniques. Therefore, people need to take an interest in their in-breast health through active, regular screening,” explained Professor Yu-mi Kim of the Early Breast Cancer Unit, Cha University Gangnam Medical Center.

BERTIS, Presented Interim Results Of Prospective Clinical StudyFor Pre- And Post-Operative MASTOCHECK At GBCC- Potential As A Monitoring Before And After Breast Cancer Treatment As Well As Early Diagnosis- Will Announce The Results Of Prospective Clinical Trials Of MASTOCHECKConducted With Major Tertiary Hospitals In The First Half Of The Year  BERTIS, a company developing early diagnosis technology based on proteomics, presented the interim results of a prospective clinical trial for MASTOCHECK, an early breast cancer diagnosis solution, at the 10th Global Breast Cancer Conference (GBCC10), attended by breast cancer experts from around the world. GBCC10, held for the 10th this year, received more than 400 abstracts, the largest number ever, and 230 world-class scholars related to breast cancer participated, making it a truly global conference. BERTIS stated that it was a conference demonstrating MASTOCHECK's performance to numerous scholars in breast cancer fields. MASTOCHECK is a technique that quantitatively measures three biomarkers in the blood that are specific to breast cancer and then determines whether it is breast cancer or not by substituting the measured values into a patented algorithm. It recorded an accuracy of 92% on the patent basis and obtained the medical device item license from the Ministry of Food and Drug Safety in 2019. According to studies on diagnosability, MASTOCHECK shows higher accuracy than mammography even when used alone, but the sensitivity increases to a higher level when combined with mammography.The results of an interim analysis in which BERTIS studied the diagnosis accuracy of MASTOCHECK and the possibility of monitoring before and after treatment such as surgery and neoadjuvant chemotherapy through prospective clinical trials. The subjects reflected in the interim results were 103 healthy women and 132 breast cancer patients. The results showed a tendency to normalize after treatment at the level of 70%, verifying the possibility that MASTOCHECK can be used not only for early diagnosis but also for monitoring before and after breast cancer treatment. This is more than 50%p higher than CA15-3, a single biomarker test currently used for postoperative follow-up in breast cancer patients, which is 10 to 20% in breast cancer patients with stage 2 or lower.Yu-mi Kim, a professor at the CHA University Gangnam Medical Center who presented as a representative said, "This study required more effort and time than previous retrospective studies, and we are fortunate that we can present this meaningful prospective study." She also added, “once the final findings are derived, we can prove MASTOCHECK is clinically effective as a monitoring test for breast cancer patients."Prof. Noh, the developer of MASTOCHECK said, "The presentation at GBCC10 proved MASTOCHECK's excellence once again. In the future, we will continue research and development so that MASTOCHECK can be used effectively in the treatment process of breast cancer as well as for screening to diagnose breast cancer." Meanwhile, BERTIS has been conducting prospective clinical trials with major tertiary hospitals to evaluate the efficacy, including sensitivity and specificity, of MASTOCHECK since last year, and the results will be announced within the first half of this year.

Easy and accurate early diagnosis of breast cancer is now possible with only 1 cc of bloodA Multibiomarker-based Breast Cancer Early Diagnosis Technology “MASTOCHECK” by Bertis Acquired New Excellent Technology (NET) Certification - MASTOCHECK has acquired NET certification as a blood test method of diagnosisthat compensates for the limits of existing breast cancer screeningand as an innovative medical technology that can enter the global market and obtain meaningful results - Various benefits and forms of support are expected following the acquisition of NET certification   <(From left) Seung-man Han, CEO of Bertis, taking a commemorative photograph with Deok-cheol Gwon, CEO of the Korea Health Industry Development Institute,at the “2019 2nd New Excellent Technology (NET) Certification Awards Ceremony”> Bertis (CEO: Seung-man Han), a proteomics-based early diagnostic technology development company, acquired New Excellent Technology (NET) certification for “MASTOCHECK,” a multibiomarker-based breast cancer early diagnostic technology, at the “2019 2nd New Excellent Technology (NET) Certification Awards Ceremony” held by the Ministry of Health and Welfare and hosted by the Korea Health Industry Development Institute on the 27th of last month. MASTOCHECK is a blood test method for the public that allows for easy screening of early-stage breast cancer. Three types of protein biomarkers in the blood closely related to breast cancer are measured quantitatively, and the values obtained are going through a unique, patented algorithm for early diagnosis of the disease.1 Stage 0, 1, and 2 breast cancer can be diagnosed with only 1 cc of blood, and even stage 1 breast cancer, which is difficult to identify with other screening methods, can be diagnosed with the high accuracy rate of 92% (based on a domestic patent). MASTOCHECK acquired NET certification in the medical science field under the descriptive name “a breast cancer screening technology using the algorithmic calculation for levels of three types of breast cancer-specific plasma proteins.” In terms of the impact of this technological development, MASTOCHECK can aid diagnosis if an image is difficult to understand or decipher in early-stage breast cancer. It is also an easy and painless method useful for subjects who wish to avoid undergoing X-rays or exposing their body parts for diagnosis. Anticipation for MASTOCHECK was especially high because it is an innovative medical technology that can enter the global market, including developing countries where limited imaging tests are available and counties with Arabic culture where people are reluctant to expose their bodies. NET certification is a system run by the Ministry of Health and Welfare to discover new, domestic technology in the early stages of development. NET certifies technology’s excellence, promote its commercialization and technology transfer, and improve product reliability to support the technology to establish a base for initial market entry. A NET certification mark is granted after certification review in a total of seven fields (▲ Biotechnology, ▲ Food hygiene, ▲ Medical science, ▲ Medical devices, ▲ Drugs, ▲ Chinese medicine and ▲ Cosmetics), and various benefits are provided, such as ▲ Preferential treatment for projects supported by the Korea Health Industry Development Institute, ▲ Support for marketing including promotion in relevant exhibitions, ▲ Finding and providing overseas technical information, ▲ Technical assistance and support for acquisition of domestic and overseas quality certification and ▲ Requests for government agencies and local governments to purchase NET products on a preferential basis.4   Recently there are more additional practical benefits to promote the use of NET products. From 2017, the usage of and support for NET-certified products include the annual evaluation of institutions designated as research-oriented hospitals to encourage end buyers, such as hospitals, for preferential purchase. Additional support measures have also been taken such, as the provision of 5% more funding than the determined amount for NET-certified technologies, without relying on an assessment table when filing a claim. “License from the Ministry of Food and Drug Safety and New Excellent Technology certification, and nomination as a First Penguin-type Start-up Business are an indication that our proteomics-based early-stage diagnostic technology, MASTOCHECK, is an innovative breast cancer solution. And I am very grateful for these recognitions from the public," said Seung-man Han, CEO of Bertis. He also added that the introduction of the New Health Technology Assessment Certification by the Ministry of Health and Welfare and the National Evidence-based healthcare Collaborating Agency (NECA) led to institutional improvements that directly established the high-quality medical services system for the public. Thoughtful support from the Biohealth Innovation Start-up Center and the Comprehensive Support Center for Medical Device Industry from the initial application stage has also been a great help in acquiring this certification.” He added, “As we have an opportunity to attract continuous interest and receive fair and prompt support from relevant institutions through this certification. We will try our best to be a model case befitting the state system intent of providing high-quality medical services to the public and supporting the growth of companies.” Meanwhile, the previous breast cancer blood tests are not adequate for early diagnosis because of low accuracy due to the use of a single biomarker. MASTOCHECK, however, has many advantages, such as consistent accuracy in diagnosis regardless of whether the subject has dense breasts or non-dense breasts and zero risks from radiation exposure, because it uses multi-biomarkers. MASTOCHECK is expecting to become an innovative diagnosis solution that will overcome the limits of existing breast cancer screening methods and contribute to the promotion of early diagnosis of breast cancer. MASTOCHECK has high sensitivity and accuracy in diagnosis, as it is based on multi-biomarkers, compared to other diagnosis methods that use a single biomarker. It also makes it very easy and convenient to diagnose breast cancer as it uses patients’ blood. In recognition of these features, MASTOCHECK received a patent by the Korean Intellectual Property Office in 2014, and it currently has nine patents from four countries—Korea, the U.S.A., China, and Japan. Also, MASTOCHECK obtained a license from the Ministry of Food and Drug Safety as an in vitro diagnostic medical device in January 2019 based on its proven efficacy in the early diagnosis of breast cancer.  

Early Diagnosis of Breast Cancer is Now Possible Using Only 1 cc of BloodBertis to provide the service before the end of the year following successful commercialization...Excellence of the technology recognized at a globally-renowned conference   <Yu-mi Kim, a Clinical Professor in the Breast Care Center of Seoul National University Hospital, presenting a paper at ASCO 2019>  An algorithm-based multimarker proteomics technology has been commercialized and is getting a lot of attention. Bertis (CEO: Seung-man Han), a bio venture company, announced on the 4th that its technology for breast cancer diagnosis, “MASTOCHECK,” which uses an algorithm-based proteomics multimarker analysis with 1 cc of blood, was approved by the Ministry of Food and Drug Safety. MASTOCHECK is a multibiomarker-based blood test method that can diagnose early-stage breast cancer by measuring levels of three types of protein (neural cell adhesion molecule L1 protein (NCHL1), apolipoprotein C1 (APOC1) and carbonic anhydrase 1 (CAH1)) and running the measurements through a patented algorithm. Screening is possible using only 1 cc of blood. With its proven efficacy in detecting stage 0, 1 and 2 breast cancer, MASTOCHECK acquired a license from the Ministry of Food and Drug Safety for an in vitro diagnostic medical device in January 2019. The technology has also been recognized globally following Bertis’ joint presentation of MASTOCHECK at the “American Society of Clinical Oncology (ASCO) 2019” with a research team from the Breast and Endocrine Surgery Department of Seoul National University.The research, presented in a poster session at the 2019 ASCO Annual Meeting held in Chicago, U.S.A., from May 31 to June 4, provided data on the accuracy of the diagnosis algorithm, and the repeated diagnosis and for other carcinomas, from evaluations of the clinical efficacy of MASTOCHECK in breast cancer diagnosis based on a total of 1,129 blood samples. This diagnostic technology that has been attracting so much attention from researchers around the world acquired a license from the Ministry of Food and Drug Safety early this year, and medical services are expected to become available later in the year. MASTOCHECK is expected to provide considerable convenience in diagnosis for the general public or for patients who have avoided breast cancer screening because of the painful X-rays or breast prostheses, and is thereby expected to significantly improve the situation for the early diagnosis and death rates for breast cancer. “The efficacy of MASTOCHECK in early diagnosis of breast cancer has been recognized by renowned cancer specialists around the world through ASCO 2019, the world’s top authority in cancer research,” said Seung-man Han, CEO of Bertis. He also said that Bertis would do its best to overcome the limits and problems of current screening systems and contribute to promoting early diagnosis of breast cancer, cancer with the highest incidence in women, through MASTOCHECK, a simple screening solution with proven accuracy. Development of MASTOCHECK started approximately 10 years ago through joint research with the Breast and Endocrine Surgery Department of Seoul National University. This breast cancer technology was based on approximately 1,700 blood samples. Cases of breast cancer screening technology developed through such large-scale sample collection are very rare, not only in Korea but in other countries. Common screening methods for diagnosing breast cancer showed low sensitivity, specificity and accuracy in Asian women, who have dense breasts in most cases. There has been constant demand for a more accurate and general screening method due to the discomfort caused by screening and the resulting decrease in compliance. The current screening system has limits, considering the risk of breast cancer to the lives of women and the growing incidence of the disease. MASTOCHECK, developed by Bertis, has obtained 9 patents from 4 countries - Korea, U.S.A., China and Japan.