BioInfra "Developing Early Breast Cancer Diagnosis Method... Preparing for Commercialization"

[Asia Economy Reporter Hyunseok Yoo] Bioinfra Life Sciences announced on the 18th that it has developed a technology capable of early breast cancer diagnosis with high accuracy by using an optimal multi-miRNAs biomarker and algorithm for breast cancer through joint research with the genetic diagnosis company Diojin.

The currently used breast cancer screening method is mammography. According to the company, it is the only scientifically proven method to reduce breast cancer mortality.

A company official stated, "As breast density increases, the sensitivity of the test decreases, and in the case of dense breasts, there is a limitation with a false-negative rate as high as 50%. For Korean women, 70% of whom have dense breasts, mammography and breast ultrasound tests must be performed together for accurate breast cancer diagnosis."

Breast ultrasound has the advantage of high sensitivity even in dense breasts and can detect breast cancer lesions that are difficult to find with mammography. However, it has the disadvantages of high dependence on the equipment and examiner, as well as a high false-positive rate, leading to additional examination costs.

This study analyzed candidate miRNAs in the blood that can distinguish between breast cancer patients (226 individuals) and normal controls (146 individuals) to discover the optimal multi-miRNAs biomarker panel. Additionally, it developed a predictive algorithm for high-risk breast cancer groups using this panel.

A company representative explained, "This study is a new auxiliary breast cancer diagnostic method that can complement the limitations of existing mammography and breast ultrasound tests used to diagnose breast cancer. It confirmed that the test method using multi-miRNAs biomarkers shows a much better diagnostic rate than existing methods."

Until now, Bioinfra has been providing a service to predict high-risk breast cancer groups using multi-protein biomarkers. The company emphasized that securing technology to diagnose early breast cancer patients more accurately through joint research with Diojin is of great significance.

Dr. Cheolwoo Kim, Chief Technology Officer of Bioinfra, said, "This study is expected to be very useful in effectively screening high-risk individuals with a high risk of breast cancer among asymptomatic general populations through a validated combination of multi-miRNAs markers. We are currently pursuing domestic regulatory approval from the Ministry of Food and Drug Safety for the breast cancer risk prediction service (X-FINDER BC) to commercialize the research results quickly and plan to enter clinical trials early next year." He added, "Furthermore, to enter overseas markets first, we have already obtained manufacturing approval for in vitro diagnostic medical devices (for export)."

Meanwhile, the company stated that the research results were published on the 17th in the international academic journal Molecular and Clinical Oncology in the form of a paper titled "Discovery of a Multi-Gene Biomarker Panel for Early Diagnosis of Breast Cancer."