Page 73 - JCTR-11-3

Journal of Clinical and
Translational Research N-NOSE: Early cervical cancer screening

diagnostic test accuracy, impacting the performance of Acknowledgments
the screening test. 44-46 This discrepancy may arise due to
prospective analyses inadvertently favoring exceptionally We are grateful to the medical doctors and staff of the
high diagnostic accuracy scenarios that do not reflect the National Hospital Organization Shikoku Cancer Center
variability encountered in routine clinical settings. 42,47,48 Hospital, Japan, for their approval of the study design at
their institutional review board, for recruiting patients
Even with limitations in specificity and sensitivity, the with written informed consent, and for collecting the
use of cancer screening tests in asymptomatic populations patients’ urine samples and clinical data. We also thank
can significantly reduce cancer-related mortality. 49,50 Mamie Egashira, Hisayo Noguchi, Satoka Okuda, Kumiko
Early detection of cancer enables timely intervention Ishihara, Rie Nakamura, Kaori Sadasue, Nagisa Matsumura,
and improves survival rates, although outcomes may still and Nobuaki Kondo from Hirotsu Bio Science Inc., Japan,
be affected by aggressive cancer types and other factors for their helpful assistance in N-NOSE data acquisition
beyond diagnosis. 41,50 Reducing the incidence of late-stage and statistics.
diagnoses offers substantial benefits for both patients and
healthcare systems. To maximize the impact of screening, Funding
51
it is essential to adopt personalized screening intervals, None.
continuously develop and improve the tests, and integrate
them into comprehensive prevention and treatment Conflict of interest
strategies. Even moderately performing tests can contribute
to public health outcomes by enhancing accessibility, The authors are employees of HIROTSU BIO SCIENCE
affordability, and participation while driving technological Inc., which developed and commercialized the N-NOSE
advancements and promoting health awareness. 50,52 technology described in this paper. T.H. is the CEO and
Founder. The authors declare that these affiliations have
Our findings suggest that the N-NOSE test is a highly not influenced the design, conduct, interpretation, or
sensitive, non-invasive, and convenient method suitable reporting of the research presented in this study.
for detecting early cervical carcinogenesis, such as CIN.
This aligns with the growing interest in novel, accessible Author contributions
screening tools that can address disparities in cervical Conceptualization: Takaaki Hirotsu
cancer detection and prevention. Further research is Data acquisition: Hideyuki Hatakeyama
9,53
warranted to confirm these findings in diverse populations, Supervision: Hideyuki Hatakeyama, Takaaki Hirotsu, Eric
particularly in underserved communities with limited di Luccio
access to traditional screening methods. Exploring the Project administration: Takaaki Hirotsu
potential of N-NOSE as a tool for detecting early-stage Writing – original draft: Hideyuki Hatakeyama
cancer may offer a promising opportunity to advance Writing – review & editing: Hideyuki Hatakeyama, Aya
global health equity in cervical cancer prevention. Hasan Alshammari, Masayo Morishita, Umbhorn

5. Conclusion Ungkulpasvich, Junichi Yamaguchi, Eric di Luccio
In this study, N-NOSE has demonstrated the potential Ethics approval and consent to participate
to identify CIN as a pre-cancerous stage, as well as This prospective study was conducted in accordance
subsequent intraepithelial lesions and invasive cervical with the Declaration of Helsinki and received ethical
cancer. Our N-NOSE test offers an affordable and non- approval from the Ethics Committee of the National
invasive approach for the early detection of progressive Hospital Organization Shikoku Cancer Center (approval
cervical carcinogenesis, enabling timely intervention and number: 3045-1). All participants provided written
treatment. This is particularly significant for low- and informed consent before enrollment, which included
middle-income countries with limited access to traditional an agreement for the collection and analysis of urine
screening methods. samples for research purposes, as well as the potential
As highlighted in our recent review, the development publication of anonymized data. The study did not involve
9
and implementation of innovative, accessible screening any interventions or changes to the participants’ standard
tools, such as N-NOSE are crucial for addressing global clinical care.
disparities in cervical cancer detection and prevention.
The commercial availability of N-NOSE in Japan, with Consent for publication
over 700,000 individuals screened to date, underscores its Written informed consent for publication was obtained
potential to improve public health. from all participants involved in the study.

Volume 11 Issue 3 (2025) 67 doi: 10.36922/jctr.24.00080