BERTIS, Presented Interim Results Of Prospective Clinical Study

For 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 MASTOCHECK

Conducted 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.