HIROTSU Bio Science Announces Publication in Cells Demonstrating N-NOSE®’s Efficacy in Evaluating Neoadjuvant Chemotherapy Response for Breast Cancer

2025.08.26

Establishing a non-invasive biomarker to predict Pathological Complete Response (pCR) and optimize breast cancer treatment pathways.

TOKYO, JAPAN – August 26, 2025 – HIROTSU Bio Science Inc. announced the publication of an original research paper in the international scientific journal Cells (published June 21, 2025). The study demonstrates the clinical utility of N-NOSE®, a nematode-based cancer screening test, in evaluating the treatment response to Neoadjuvant Chemotherapy (NAC) in breast cancer patients.

This prospective clinical study was conducted in collaboration with Gifu University Hospital, a prominent national medical institution in Japan, led by Professor Manabu Futamura (Breast Surgery) and Professor Nobuhisa Matsuhashi (Gastroenterological and Pediatric Surgery).

Background and Clinical Unmet Need Breast cancer is one of the most common cancers among women globally and remains a leading cause of cancer-related mortality, urgently requiring technological advancements in both diagnosis and treatment monitoring.

Clinically, breast cancer is categorized into four subtypes based on the expression levels of estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 (HER2). For many patients with high-risk early breast cancer across these subtypes, Neoadjuvant Chemotherapy (NAC) is the standard of care. Previous studies have shown that achieving a Pathological Complete Response (pCR)—particularly in HER2-positive and triple-negative high-risk breast cancers—is associated with significantly better survival outcomes. Therefore, accurately evaluating pCR is critical in clinical settings.

Currently, assessing treatment efficacy relies heavily on imaging tests such as Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). However, these imaging modalities alone cannot definitively rule out residual microscopic lesions, creating a demand for novel, non-invasive assessment tools.

Study Overview and Key Findings To validate the efficacy of N-NOSE in predicting NAC response, the research team conducted a prospective clinical study enrolling 36 breast cancer patients who received NAC followed by surgery. Using the nematode chemotaxis analysis, the team calculated the Index Reduction Score (IRS1–3), a metric reflecting the change in chemotaxis index values between treatment stages.

• High Predictive Power for pCR: Pathological Complete Response （pCR） was achieved in 36.1% of the patients.
• Superiority of IRS3: Among the three types of IRS analyzed, IRS3 （calculated by subtracting the postoperative chemotaxis index from the pre-treatment chemotaxis index） demonstrated the highest predictive capability for pCR, yielding an Area Under the Curve （AUC） of 0.75.

Conclusion and Impact These results indicate that the Index Reduction Score derived from the urine-based N-NOSE test holds significant potential as a highly useful, non-invasive biomarker for evaluating treatment efficacy in breast cancer patients, complementing traditional imaging techniques.

Since its launch in January 2020, N-NOSE has screened over 800,000 individuals. The fundamental science of nematode olfactory-based cancer detection has been successfully replicated by prominent research institutions in the United States and Italy, with recent corroborating data also published by institutions in Slovakia. Through ongoing global clinical studies, HIROTSU Bio Science aims to establish this unique technology as a fundamental tool not only for early cancer screening but also for comprehensive treatment monitoring.