

MastoCheck is a blood test that can easily screen for breast cancer at an early stage. Breast cancer is diagnosed early by substituting the quantitative values of three types of protein biomarkers in the blood, which are closely related to breast cancer, into a unique, patented algorithm. An innovative and convenient test method that detects early breast cancer with an accuracy of 92% (based on the patent) by using only a very small amount of blood. Bertis has developed multiple markers that can detect early breast cancer with an accuracy of 92% through identification of multiple proteins that are expressed sensitively in early-stage breast cancer and combination of certain proteins that demonstrated high accuracy and reproducibility among these combinations. DEVELOPMENT PROCESS: - MASTOCHECK was developed by a team led by Professor Dong-Young Noh, a world-renowned authority on breast cancer, of Seoul National University. - After analyzing approximately 600,000 proteins and selecting 3 markers exhibiting optimal accuracy, the highest accuracy was obtained by adding Bertis�¢?? own algorithm that enhances accuracy. - After several years of repeated validation work, a medical device product license was obtained from the MFDS in January 2019. To date (as of September 2023), MASTOCHECK has been introduced to about 400 hospitals and screening institutions nationwide, with priority given to large screening institutions.
| HS Code | 3822.90 |
| Brand | EximNext |
| Material | Diagnostic Reagent Composition: Protein Biomarkers, Antibodies, ELISA Substrate Solution, Calibrator Controls, Wash Buffer |
| Product Type | Quantitative ELISA Diagnostic Kit for Breast Cancer Screening |
| Target Biomarkers | 3 Protein Tumor Markers (CA 15-3, CEA, and Additional Breast Cancer Associated Proteins) |
| Sample Type | Serum or Plasma (venous blood) |
| Test Format | 96-well Microplate ELISA (quantitative) |
| Sensitivity / Detection Range | High sensitivity; specific detection range per biomarker indicated in product insert |
| Intended Use | Early-stage breast cancer screening, disease monitoring, and recurrence detection in clinical laboratory settings |
| Storage / Stability | 2-8°C (refrigerated); stable until expiry date on packaging |
| Packaging | 96 tests per kit box; individual sealed strips available; includes calibrators, controls, and reagents |
| Regulatory Classification | In Vitro Diagnostic (IVD) Medical Device; CE / FDA cleared variants available |
| Shelf Life | 12 months from manufacture date (minimum) |
| Origin | Product of Record; contact manufacturer for country of origin details |
MastoCheck is a quantitative in vitro diagnostic kit designed for early breast cancer screening through detection of specific protein biomarkers in blood serum or plasma samples. Suitable for clinical pathology laboratories, oncology departments, and hospital diagnostic centers, this kit supports high-throughput screening workflows with standard ELISA instrumentation. As a regulated Class II/III medical device, it requires proper cold-chain logistics and is classified under standard diagnostic reagent HS codes for international trade clearance.
| Business Type | Supplier |
| Year Established | Recently Joined |
| Employees | Contact Supplier |
| Annual Revenue | Contact Supplier |
| Main Products | View Products Tab |
| Major Markets | Global |
| Response Time | <4h |
| Response Rate | New Supplier |
MASTOCHECK Breast Cancer Early Diagnosis is offered by Bertis Inc., a Supplier based in South Korea (Republic Of Korea). This supplier provides wholesale quantities suitable for bulk importers, distributors, and businesses worldwide. Contact the supplier to request pricing, discuss trade terms, and arrange shipping to your destination.
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