Bertis Establishes U.S. Operations to Bring Novel Proteomics-Based Diagnostics to the U.S. Market

As a leading proteomics technology company in Asia, Bertis plans to bring its unique proteomic and data science-based diagnostic tests to clients in the U.S.

SEOUL, Korea, Oct. 11, 2022 /PRNewswire/ -- Bertis Inc., a South Korean proteomics-based precision medicine technology company, announced today it has established a U.S.-based wholly-owned entity to expand the company's global presence and primarily provide access to the growing U.S. clinical testing market.

The company's U.S. subsidiary, called Bertis Bioscience, is incorporated in Delaware and aims to establish a San Diego-based CLIA-certified lab facility in early Q4, 2022 to offer its expanding array of highly differentiated proteomics-based screening and diagnostic tests, as well as an analysis platform to integrate multi-omics data.

Proteomics, the study of proteins in the human body, has emerged as a promising field in medicine, particularly for its potential to identify subtypes of cancers and match patients with the most appropriate treatment strategy¹. Even though the cancer survival rate in the U.S. has increased over the past 28 years², some types of cancer are still difficult to detect at early stages, with no standard early diagnosis method. Proteomics has also been in the spotlight as the U.S. Cancer Moonshot initiative promoted a proteome consortium to encourage international collaboration and investment across countries in cancer research and treatment.³

Bertis has established a foundation for precision medicine by developing diagnostic solutions based on technology that combines proteomics and AI, which has enabled the company to emerge as a leader in proteomics and bioinformatics in Asia. The company has successfully commercialized in South Korea MASTOCHECK^TM, the world's first proteomics-based breast cancer blood test solution.

In Korea, the solution has been used at over 170 health clinics and hospitals nationwide since marketing approval as an in vitro diagnostic medical device from the Ministry of Food and Drug Safety in January 2019. Bertis has gained a foothold in the Asian market by recently signing a contract with one of Singapore's largest medical groups, Raffles Medical Group, to supply MASTOCHECK^TM. Through this contract, MASTOCHECK^TM will be introduced to the Raffles Breast Centre, Raffles Health Screeners, and over 30 Raffles medical clinics in Singapore.

"We are excited to establish Bertis Bioscience in the U.S. We believe Bertis' unique and powerful approach to proteomics-based precision medicine will positively impact medical professionals and patients in the U.S. as it has in Asia," said Seungman Han, Bertis founder and co-CEO. "With the San Diego site underway, Bertis aims to build on its success in South Korea and Asia and become a trusted partner to medical professionals and patients in the U.S. aiming to rapidly and effectively identify and treat a range of life-threatening diseases."

The company is also developing a novel artificial intelligence and machine learning approach to maximize the utilization of protein information by discovering the 'dark matter' of the proteome, which is currently not accessible. Bertis' unique and expanding expertise in analyzing and interpreting the proteome is expected to enable the company to expand into additional applications and diseases where there are high unmet medical needs in detection and treatment, such as ovarian cancer and pancreatic cancer.

Recently, Bertis' research team presented protein biomarkers for early diagnosis of high-grade serous ovarian cancer (HGSOC) with 95% accuracy⁴. The results of this study were published in the September issue of the Journal of Proteome Research by the American Chemical Society.

In this study, the research team identified 18 candidate proteins after quantifying 1,847 serum proteins, the highest number ever reported as ovarian cancer biomarker research results, through Bertis' technology platform to discover biomarker candidates. As a result of developing and evaluating a predictive model, the accuracy of the diagnostic value for stages 1 to 3 HGSOC was 95% (sensitivity 100%, specificity 91%) when 18 candidate proteins were combined with multiple biomarkers.

For more information on Bertis Bioscience, please email us at [email protected].  

About Bertis

Bertis is a pioneer of proteomics-based disease detection and therapy companion diagnostics. Bertis' capabilities range from cancer, disorder biomarker discovery, low-cost diagnostics manufacturing and analysis services. Since its inception in 2014, the company has been focused on developing and improving technologies for early diagnosis solutions with the most advanced quantitative proteomics research, precision medicine based on companion diagnostic markers, and target discovery for oncology drug development and personalized treatment. Flagship solutions include MASTOCHECK, the world's first proteomics-based blood test solution for early breast cancer detection, and PASS (Pan-omics Analysis Service & Solution), a platform for integrative analysis of multi-omics data. For more information, please visit our website www.bertis.com or follow us on LinkedIn www.linkedin.com/company/bertis-inc. 

About MASTOCHECK

MASTOCHECK is a proteomics-based breast cancer detection test developed by Bertis Inc. and has been offered to the public in South Korea since 2019. MASTOCHECK uses patented algorithms to analyze plasma protein biomarkers specific to breast cancer. MASTOCHECK can analyze samples as small as 1ml plasma to diagnose early-stage breast cancer with high sensitivity. MASTOCHECK has been patented by the Korean Intellectual Property Office since 2014, and 10 patents are currently registered in four countries - Korea, the United States, China and Japan. MASTOCHECK was approved as an in vitro diagnostic medical device by the South Korean Ministry of Food and Drug Safety in January 2019 based on the test's efficacy in the detection of early breast cancer and certified as New Excellent Technology (NET) by the Korea Health Industry Development Institute (KHIDI) in September 2019. For more information, please visit the MASTOCHECK website: http://www.mastocheck.com/

¹ Li Zhou et al. Clinical proteomics-driven precision medicine for targeted cancer therapy: current overview and future perspectives.  PMID: 26923776. Available at 10.1586/14789450.2016.1159959.

²  Rebecca L. Siegel MPH et al. Cancer Statistics. Available at  https://doi.org/10.3322/caac.21708

³ National Cancer Institute. Division of Cancer Treatment & Diagnosis. Available at https://icpc.cancer.gov/portal/

⁴ Sunghyun Huh et al. Novel Diagnostic Biomarkers for High-Grade Serous Ovarian Cancer Uncovered by Data-Independent Acquisition Mass Spectrometry. J. Proteome Res. 2022, 21, 9, 2146–2159. Available at https://doi.org/10.1021/acs.jproteome.2c00218 

SOURCE Bertis Inc.