MASTOCHECK, Blood Test for Early Breast Cancer detection,
Now Available in Clinical Practice
as an After-Entry Medical Technology
- MASTOCHECK, a convenient and highly accurate detection technique for early breast cancer without age restrictions and radiation exposure
- Will be available in clinical practice from July 1 for diagnosis purposes beyond health screening
- Bertis: “Significant as the first introduction of proteomics-based solution in Koran clinical practice”
June 27, 2022, SEOUL, KOREA -- Bertis Inc., a South Korean biotech dedicated to proteomics-based precision medicine, today announced the confirmation of the after-entry medical technology of MASTOCHECK®, a blood test for early breast cancer detection, as an In vitro diagnosis by evaluation of the new Health Technology Assessment (nHTA) from National Evidence-based healthcare Collaborating Agency (NECA).
MASTOCHECK developed by Bertis is the world’s first proteomics-based blood test for early breast cancer. The assay measures three breast cancer-specific biomarkers in blood and the measured quantitative values are put into the company’s unique and patented algorithm for diagnosis. Only a very small amount of blood is taken to detect stages 0 through 2 breast cancer. This blood test has no age restrictions on use, and it can determine whether stage 0-2 breast cancer is present in a convenient and highly accurate manner without radiation exposure.
With the confirmation, MASTOCHECK will be available in clinical practice without reimbursement from July 1 for the diagnosis of people with suspected breast cancer. The availability period is two years according to the nHTA grace system updated by the Ministry of Health and Welfare in January, and if the nHTA application is filed 30 days before the end of the availability period, it can be used until the date of notification of the application result.
With the expanded purposes of MASTOCHECK, Bertis expects it to be more used across clinics and hospitals beyond routine health screening. MASTOCHECK has been used for early breast cancer detection during a health checkups at some 100 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.
“This confirmation of after-entry medical technology is significant in that the proteomics-based solution is available in Koran clinical practice for the first time beyond market entry and expansion of MASTOCHECK as a test,” said Han Seung-man, chief executive officer of Bertis. “As a leader in the field of proteomics, we will be committed to harnessing the potential of proteomics technology in clinical practice, enabling more people to enjoy the benefits of proteomics-based precision medicine.”
Bertis has discovered biomarkers for cancer and other major disorders and provided diagnostic and analysis solutions based on the combination of proteomics and bioinformatics. Bertis has a track record of successful commercialization of proteomics technology through MASTOCHECK, the world’s first proteomics-based blood test for early breast cancer detection, and PASS (Pan-omics Analysis Service & Service), a platform for integrative analysis of pan-omics (multi-omics) data. The company is also conducting research on early diagnosis solutions for pancreatic cancer and ovarian cancer.