HIROTSU BIO SCIENCE Inc. Announces Publication in BMC Surgery Demonstrating N-NOSE®’s Efficacy in Detecting Pancreatic Cancer Recurrence.

2026.01.05

A novel, non-invasive approach to detecting micro-distant metastasis in highly lethal pancreatic cancer.

TOKYO, JAPAN – January 5, 2026 – HIROTSU BIO SCIENCE Inc. (Headquarters: Chiyoda-ku, Tokyo; Representative Director and CEO: Takaaki Hirotsu) announced today the publication of an original research paper in the international peer-reviewed journal BMC Surgery (published December 29, 2025). The study demonstrates that the company’s proprietary nematode-based cancer risk test, N-NOSE®, can effectively detect micro-distant metastasis in recurrent pancreatic cancer.

This research was conducted in collaboration with Gifu University Hospital—a leading national university hospital and a designated regional cancer care hospital in Japan. The joint clinical study was led by Professor Manabu Futamura (Breast Surgery), Professor Nobuhisa Matsuhashi (Gastroenterological and Pediatric Surgery), and Lecturer Masahiro Fukada (Gastroenterological Surgery).

Background and Clinical Unmet Need: Pancreatic cancer, one of the deadliest malignancies globally, is projected to become the second leading cause of cancer-related deaths in Western countries within the next decade. In Japan, it currently ranks fourth, with incidence rates expected to rise as the population ages. Although surgical resection is the sole curative treatment, over 50% of patients who undergo curative surgery experience recurrence within 12 months. Early detection of recurrence risk is crucial, but it remains challenging with conventional diagnostic modalities.

Study Overview and Key Findings: The clinical study assessed the prognostic value of N-NOSE using urine samples from 24 patients (13 who experienced recurrence and 11 who did not) who underwent curative resection for pancreatic cancer.

• High Positivity Rate: Of the 24 subjects, 20 (83.3%) tested positive for N-NOSE before starting treatment. Notably, all 13 patients who later experienced recurrence were N-NOSE positive prior to their treatment.
• Identification of an Independent Risk Factor: The study conducted univariate and multivariate analyses (Logistic regression models) to identify postoperative recurrence risk factors.
  • Univariate analysis showed significant differences in three factors: (1) high preoperative PLR (Platelet-to-Lymphocyte Ratio) (p=0.04), (2) pathological lymph node metastasis (p=0.04), and (3) pre-treatment N-NOSE positivity (p=0.007).
  • Multivariate analysis revealed that pre-treatment N-NOSE positivity was the only independent risk factor for recurrence (p=0.03).

Conclusion and Impact: The paper concludes that both “pre-treatment N-NOSE positivity” and “postoperative elevation of the chemotaxis index” are effective indicators of recurrence risk. N-NOSE is emphasized as an exceptionally valuable tool for detecting micro-distant metastasis in recurrent pancreatic cancer due to its simplicity, non-invasiveness (allowing for repeated sampling), and cost-effectiveness.

Since its commercial launch in January 2020, N-NOSE has been utilized by over 850,000 individuals in Japan. Additionally, the scientific validity of nematode olfactory-based cancer detection has been independently reproduced and published by research institutions in the United States, Italy, and Slovakia. HIROTSU BIO SCIENCE remains dedicated to demonstrating the clinical utility of this technology globally, advancing early cancer detection, and establishing a new global standard in cancer screening.

Publication Details

• Title: Urine-based nematode chemotaxis assay (N-NOSE) as a predictor of recurrence after curative surgery for resectable pancreatic cancer: preliminary data and single center experience
• Authors: Masahiro Fukada, Noriki Mitsui, Takeshi Horaguchi, Itaru Yasufuku, Yuta Sato, Jesse Yu Tajima, Yoshihiro Tanaka, Hideyuki Hatakeyama, Aya Hasan Alshammari, Masayo Morishita, Takaaki Hirotsu, Eric di Luccio, Manabu Futamura, Nobuhisa Matsuhashi*
• Journal: BMC Surgery