Craif Announces Joint Research Results on Early Detection of Gynecologic Tumors Using Urinary MicroRNA at AACR Annual Meeting 2026 (American Association for Cancer Research Annual Meeting)
Bio AI startup Craif Inc. announced joint research results with Hokkaido University on the non-invasive early detection of gynecologic tumors using urinary microRNA at the AACR Annual Meeting 2026. This research demonstrates a highly accurate diagnostic model and the potential to reduce psychological and physical barriers to gynecologic examinations.
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- 📰 Published: May 8, 2026 at 19:00
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Bio AI startup Craif Inc. (Location: Shinjuku-ku, Tokyo; Representative Director & CEO: Ryuichi Onose; hereinafter "Craif") jointly announced research results on gynecologic tumor screening, "Non-invasive screening of gynecologic tumors using miRNAs in urinary extracellular vesicles," with Professor Hidemichi Watari of the Department of Obstetrics and Gynecology, Faculty of Medicine, Hokkaido University, at the "AACR Annual Meeting 2026 (American Association for Cancer Research Annual Meeting)" held in San Diego, USA in April 2026. This research demonstrated the potential for highly accurate early detection of gynecologic tumors through urine tests that do not require blood sampling or hospital visits.
**Key Points of Research:**
* **High-precision gynecologic tumor detection using microRNAs derived from urinary extracellular vesicles:**
A screening panel for the detection of gynecologic tumors was constructed by comprehensively analyzing microRNAs contained in urinary extracellular vesicles (exosomes). Evaluation using a machine learning model achieved high diagnostic accuracy with an AUC of 0.937, sensitivity of 85.6%, and specificity of 94.4%.
* **Non-invasive test that lowers psychological and physical barriers to gynecologic examinations:**
In Japan, the participation rate for gynecologic examinations remains at approximately 40%, facing challenges such as psychological resistance to internal examinations and limitations in medical resources. This urine-based testing method removes these barriers, showing the potential for more women to access early gynecologic care.
* **Potential for application in large-scale screening:**
Due to the non-invasiveness and high detection accuracy of this testing method, its application in future large-scale gynecologic screening programs is anticipated. It is expected to contribute to reducing the mortality rate of gynecologic cancers through early detection and early treatment.
**Joint Research Overview:**
Gynecologic malignancies rank as the second leading cause of cancer morbidity and mortality in women, after breast cancer. Meanwhile, benign diseases such as uterine fibroids and endometriosis, despite their significant clinical burden, lack established systematic screening methods. This research explored a non-invasive screening strategy based on comprehensive profiling of urinary extracellular vesicle (EV)-derived microRNAs for both malignant and benign gynecologic diseases. The constructed diagnostic model achieved an AUC of 0.937, sensitivity of 85.6%, and specificity of 94.4%, demonstrating the potential of urinary microRNAs as useful biomarkers for early screening of gynecologic tumors.
**About AACR 2026:**
Presentation Date: Monday, April 20, 2026
Location: San Diego, California, USA
Official Website: https://www.aacr.org/meeting/aacr-annual-meeting-2026/
**Terminology Explanation:**
* **Extracellular vesicles (Exosomes):** Small, sac-like particles secreted by cells that are involved in information transfer within the body. Extracellular vesicles contain substances such as microRNAs and are attracting attention as important biomarkers useful for cancer diagnosis.
* **MicroRNA:** Very small RNA molecules within cells that play a role in regulating gene function. Changes in the types and amounts of microRNAs are observed in cancer cells, making them potentially useful for early disease detection and prognosis prediction.
* **Machine Learning:** A type of AI (artificial intelligence) technology that learns patterns from large amounts of data to make predictions and classifications. In this research, it was used to highly accurately determine the presence or absence of disease using microRNA data for cancer diagnosis.
* **AUC (Area Under the Curve):** An indicator of diagnostic accuracy, taking values from 0 to 1. A value closer to 1 indicates higher diagnostic performance.
* **Sensitivity and Specificity:** Sensitivity indicates the proportion of people with the disease who test positive, while specificity indicates the proportion of people without the disease who test negative.
**About Craif:**
Craif is a bio AI startup founded in 2018, committed to early cancer detection. By combining "NANO IP®︎ (NANO Intelligence Platform)," its unique analytical technology base for highly accurate detection of diverse biomarkers like DNA and microRNA from body fluids including urine, with AI technology, Craif develops innovative tests enabling ultra-early detection, early treatment, and early return to society for cancer patients. By broadly delivering the power of biotechnology and AI to society, Craif promotes its vision of "realizing a society where people live out their natural lifespan."
**Company Profile:**
Company Name: Craif Inc.
Representative: Ryuichi Onose, Representative Director
Established: May 2018
Capital: 100 million JPY (as of March 2024)
**Key Points of Research:**
* **High-precision gynecologic tumor detection using microRNAs derived from urinary extracellular vesicles:**
A screening panel for the detection of gynecologic tumors was constructed by comprehensively analyzing microRNAs contained in urinary extracellular vesicles (exosomes). Evaluation using a machine learning model achieved high diagnostic accuracy with an AUC of 0.937, sensitivity of 85.6%, and specificity of 94.4%.
* **Non-invasive test that lowers psychological and physical barriers to gynecologic examinations:**
In Japan, the participation rate for gynecologic examinations remains at approximately 40%, facing challenges such as psychological resistance to internal examinations and limitations in medical resources. This urine-based testing method removes these barriers, showing the potential for more women to access early gynecologic care.
* **Potential for application in large-scale screening:**
Due to the non-invasiveness and high detection accuracy of this testing method, its application in future large-scale gynecologic screening programs is anticipated. It is expected to contribute to reducing the mortality rate of gynecologic cancers through early detection and early treatment.
**Joint Research Overview:**
Gynecologic malignancies rank as the second leading cause of cancer morbidity and mortality in women, after breast cancer. Meanwhile, benign diseases such as uterine fibroids and endometriosis, despite their significant clinical burden, lack established systematic screening methods. This research explored a non-invasive screening strategy based on comprehensive profiling of urinary extracellular vesicle (EV)-derived microRNAs for both malignant and benign gynecologic diseases. The constructed diagnostic model achieved an AUC of 0.937, sensitivity of 85.6%, and specificity of 94.4%, demonstrating the potential of urinary microRNAs as useful biomarkers for early screening of gynecologic tumors.
**About AACR 2026:**
Presentation Date: Monday, April 20, 2026
Location: San Diego, California, USA
Official Website: https://www.aacr.org/meeting/aacr-annual-meeting-2026/
**Terminology Explanation:**
* **Extracellular vesicles (Exosomes):** Small, sac-like particles secreted by cells that are involved in information transfer within the body. Extracellular vesicles contain substances such as microRNAs and are attracting attention as important biomarkers useful for cancer diagnosis.
* **MicroRNA:** Very small RNA molecules within cells that play a role in regulating gene function. Changes in the types and amounts of microRNAs are observed in cancer cells, making them potentially useful for early disease detection and prognosis prediction.
* **Machine Learning:** A type of AI (artificial intelligence) technology that learns patterns from large amounts of data to make predictions and classifications. In this research, it was used to highly accurately determine the presence or absence of disease using microRNA data for cancer diagnosis.
* **AUC (Area Under the Curve):** An indicator of diagnostic accuracy, taking values from 0 to 1. A value closer to 1 indicates higher diagnostic performance.
* **Sensitivity and Specificity:** Sensitivity indicates the proportion of people with the disease who test positive, while specificity indicates the proportion of people without the disease who test negative.
**About Craif:**
Craif is a bio AI startup founded in 2018, committed to early cancer detection. By combining "NANO IP®︎ (NANO Intelligence Platform)," its unique analytical technology base for highly accurate detection of diverse biomarkers like DNA and microRNA from body fluids including urine, with AI technology, Craif develops innovative tests enabling ultra-early detection, early treatment, and early return to society for cancer patients. By broadly delivering the power of biotechnology and AI to society, Craif promotes its vision of "realizing a society where people live out their natural lifespan."
**Company Profile:**
Company Name: Craif Inc.
Representative: Ryuichi Onose, Representative Director
Established: May 2018
Capital: 100 million JPY (as of March 2024)