hanamisui(japan)

Hanamisui Establishes High-Precision Quantitative Measurement System for "Vaginal Flora" Using RT-qPCR Method

~ Strengthening Evidence Creation for Femtech through a Scientific Approach from the Perspective of a Female Researcher Team~

Hanamisui Inc. (Headquarters: Shinjuku-ku, Tokyo; CEO: Ji-Hwan Pang), a company that develops and sells medical devices for obstetrics and gynecology as well as femcare products, has established a research framework within its R&D department to accurately analyze the "vaginal flora (microbiome)," which is essential for maintaining women's health, using molecular biological methods.

This system quantitatively evaluates the vaginal environment, which is closely associated with female-specific discomfort and infection risks, using the RT-qPCR method. By having female researchers—who are themselves stakeholders—lead the development, the company aims to address delicate issues in clinical settings and daily life from a woman's perspective, accelerating the development of next-generation femcare solutions based on scientific evidence.

■ Development Background: Fusion of a Stakeholder's "Perspective" and "Scientific Verification"

Although many products are currently distributed in the femtech market, objective indicators demonstrating their efficacy and biological impact remain limited.

The female researcher team in Hanamisui's R&D department sought to visualize subjective issues they personally experience, such as "changes in vaginal discharge and discomfort," utilizing the power of biotechnology. By combining their expertise as a medical device manufacturer with a unique female perspective, they have constructed a highly effective measurement system.

■ Technical Features: Precise Measurement of "Live Bacteria" using the RT-qPCR Method

This system utilizes the RT-qPCR (Reverse Transcription Real-Time PCR) method, which targets bacteria-derived RNA (ribonucleic acid), as an indicator to evaluate the vaginal microbiome.

- Analysis specialized in "live bacteria": By targeting RNA produced during metabolic activity rather than highly stable DNA, the system accurately detects the status of "currently active bacteria" while excluding dead bacteria.
- Establishment of quantitative evaluation: By comparing samples with known standards (standard strains), the copy number of target bacteria (e.g., lactic acid bacteria groups) is measured in real-time. This allows for the numerical calculation of chronological changes in the vaginal environment and comparisons before and after product use.
- High-sensitivity measurement capability: Since RNA exists in copy numbers tens of thousands to millions of times greater than DNA, highly sensitive measurements are possible.

■ Comment from the Lead Researcher (Female Researcher)

"An imbalance in vaginal flora significantly lowers the quality of life (QOL), yet until now, women have often had to rely on self-diagnosis or physical sensations. This system enables us to scientifically visualize exactly which bacteria are present and in what quantities. Moving forward, we intend to utilize this platform to provide women with safer, more reliable, and evidence-based products."

■ Future Outlook: Collaboration with Medical and Research Institutions

Hanamisui will utilize this system to advance the accumulation of clinical evidence for its products. In the future, the company also plans to pursue joint research with medical institutions and universities, contributing to the elucidation of mechanisms by which a normalized vaginal environment supports women's overall health.