Bertis Announces Research Results on Prognosis Observation of Breast Cancer Surgery including Recurrence Diagnosis Using Mastocheck®

- Published the study results analyzing the usefulness of Mastocheck® and the performance of diagnosing local recurrence in observing the prognosis of patients undergoing breast cancer surgery in the international journal ‘Journal of Cancer Research and Clinical Oncology’

- Showed higher sensitivity than the existing single biomarker CA15-3 test in patients more than 1 year after surgery, with respect to local recurrence

Bertis, a proteomics-based precision medicine technology development company (CEOs Dong-young Noh and Seung-man Han), announced the results of a study evaluating the utilization of Mastocheck® in observing the prognosis of patients undergoing breast cancer surgery on January 19, 2023.

Mastocheck® is a convenient technique that screens for the presence of breast cancer through patented algorithmic calculations of three plasma protein levels specific to breast cancer. This solution proved its effectiveness in diagnosing stage 0 to 2 breast cancer and its approval as a medical device for In Vitro diagnosis was obtained from the Ministry of Food and Drug Safety in 2019 and after being selected as a Conditional Approval System of Health Technology (The conditional approval scheme for highly needed medical devices) in 2022. The solution has been used as an early breast cancer diagnosis test at health examination centers and hospitals.

The study results verified the potential of Mastocheck®, which is useful for prognosis management after breast cancer surgery, including early diagnosis of local recurrence.  The research paper was published in the international journal ‘Journal of Cancer Research and Clinical Oncology’ last December.

The study was conducted with two cohorts of a total of 255 breast cancer patient groups, with the aim of confirming the effectiveness of Mastocheck® in managing the prognosis of patients who underwent breast cancer surgery and assessing its performance in the early diagnosis of local recurrence.

For the first cohort, changes in Mastocheck® values were analyzed for the regular follow-up periods which span from the breast cancer diagnosis (prior to the surgery) to after the surgery. The results of Mastocheck® decreased significantly over time after surgery compared to before the surgery (p<0.001), indicating a non-cancerous healthy condition according to Mastocheck® criteria. Of 111 patients in the cohort, two blood analyses were performed on 108 patients and three analyses were performed on 53 patients. Mastocheck value was within the normal range (result value, <0.0668) in 68.5% (in 74 of 108 patients) at 8 weeks after the surgery and in 88.7% (in 47 of 53 patients) at 6 months to 1 year after the surgery.

The assessment of the diagnosis of local recurrence after breast cancer surgery was conducted in cohorts of patients who had undergone the surgery more than a year ago. In the study, both Mastocheck® and as a control, CA15-3, the single biomarker blood test which has been used for recurrence follow-up after surgery, were performed on all patients, divided into patients with confirmed recurrence and patients without recurrence (i.e., healthy patients)

According to this cohort analysis, the diagnostic accuracy of Mastocheck® for local recurrence was 71.5% (sensitivity 60.3%, specificity 80.2%). In contrast, CA15-3 test results performed on relapsed patients showed that 98.4% of relapsed patients enrolled in the study were within the normal range, indicating that Mastocheck® outperformed CA15-3 in diagnosing local recurrence.

“It is important to detect early recurrence in post-surgery management of breast cancer, and more advanced diagnosis options are needed in the medical field,” said Professor Yumi Kim of the Department of Surgery at CHA Gangnam Medical Center, CHA University, who led this study. She added, “Since this study verified the possibility of using multi-biomarker-based blood tests for prognosis management of breast cancer surgery patients, including early diagnosis of local recurrence, we plan to continue examining the usefulness of the test through clinical studies.”

Mastocheck® can be used as a non-reimbursable treatment for suspected breast cancer patients, as it was designated as a Conditional Approval System of Health Technology in June 2022 and has been introduced to around 300 domestic hospitals and health check-up centers. This solution has also been introduced to Raffles Medical Group, Singapore's large-scale private medical groups, and Solis Breast Care & Surgery Centre, a specialized hospital for breast health and is used by more than 40 medical institutions for diagnosis.