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MASTOCHECK, Blood-Based Solution for Early Breast Cancer Screening, Now Available at 100 Major Health Centers Nationwide
- MASTOCHECK can accurately detect stages 0 through 2 breast cancer with a microscopic amount of blood
- Since regulatory approval by the Ministry of Food and Drug Safety (MFDS) in 2019, more health centers have joined the wide array of partnerships to service Mastocheck, now at 100 large health clinics and hospitals nationwide 
Bertis Inc, which develops proteomic-based precision medicine, today announced a growing list of partnered medical institutions for MASTOCHECK®, further expanding access to its innovative and convenient blood test for early breast cancer, now available through 100 large health clinics and hospitals nationwide. MASTOCHECK is the world’s first proteomic-based breast cancer multi-biomarker solution developed by Bertis. The assay measures three breast cancer-specific biomarkers in blood and the company’s unique and patented algorithm analyze quantitative biomarkers’ values to provide the result of the diagnosis. Only a small amount of blood is required to detect stages 0 through 2 breast cancer. Bertis received the regulatory approval of MASTOCHECK as an in vitro diagnostic medical device from the MFDS in January 2019 based on the result of a pivotal clinical trial that evaluated the efficacy of the device in the detection of stages 0 through 2 breast cancer. Since then, the company has expanded access to its solution to large health centers across the country. MASTOCHECK is in the spotlight for its high-level screening accuracy, especially in dense breast tissue. Dense breasts, where fibroglandular tissue accounts for more than 50% of the breast composition, may limit imaging sensitivity in mammography. Eight out of ten Korean women are account for having dense breast tissue, and about 400,000 women end up receiving ‘deferred judgment’ in an annual national mammography screening program. ‘Deferred judgment’ is the case where the result is inconclusive therefore, additional mammography test or further validation from different testing or comparison with previous images are required. MASTOCHECK plays a role as an effective solution to ensure accurate diagnosis and detection of breast cancer in case of ‘deferred judgment’ due to dense breasts and other associated issues. In a clinical trial, a combination of MASTOCHECK and mammography showed a high level of sensitivity even in dense breast tissue. The sensitivity of the combination of both tests in dense breasts (Bi-RADS grade 3 and 4) was 93.0%, significantly higher than 59.2% in mammography alone. “MASTOCHECK is an innovative blood-based diagnostic solution that encourages breast screening by its prompt, accurate screening process at the screening centers,” said Seung-man Han, the chief executive officer at Bertis. “As it is a season for a regular health screening and breast examination, we will try our best to align with the major healthcare screening centers and hospitals in order to effectively provide Mastocheck for those who need our service.” Bertis provides useful information on breast cancer and MASTOCHECK on its website. For the list of regional centers that provide MASTOCHECK service and more, please visit our website at http://www.mastocheck.com/.
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