TruScreen’s Validation Raises Stakes in Cervical Cancer Screening Market Race
TruScreen has been confirmed as a superior primary cervical cancer screening device in the world’s largest opto-electronic study, outperforming traditional cytology and matching HPV testing accuracy.
- Largest international opto-electronic cervical screening study with nearly 15,000 women
- TruScreen shows higher sensitivity and negative predictive value than Liquid Based Cytology
- Performance comparable to high-risk HPV DNA testing for detecting severe precancerous lesions
- Study published in respected BMC Cancer journal and endorsed by Chinese medical associations
- Supports integration of TruScreen into Chinese national screening guidelines and emerging markets
A Landmark Validation for TruScreen
TruScreen Group Limited (ASX, TRU) has achieved a significant milestone with the publication of the largest ever international study validating its AI-enabled cervical cancer screening device. Conducted by the Chinese Obstetricians and Gynaecologists Association (COGA) between 2018 and 2021, the study involved nearly 15,000 women across 64 hospitals in nine Chinese provinces. The results, published in the reputable BMC Cancer journal, demonstrate that TruScreen outperforms the conventional Liquid Based Cytology (LBC) method and matches the accuracy of high-risk Human Papillomavirus (hrHPV) DNA testing in detecting high-grade cervical lesions.
Superior Sensitivity and Predictive Value
The study focused on detecting cervical intraepithelial neoplasia grades 2 and 3 (CIN2+ and CIN3+), which are severe precancerous conditions. TruScreen achieved a sensitivity of 87% for CIN2 and 90% for CIN3, significantly higher than LBC’s 66.4% and 62.7%, respectively. Its negative predictive value; indicating the test’s reliability in ruling out disease; also surpassed LBC and was comparable to HPV DNA testing. These metrics highlight TruScreen’s ability to accurately identify true positives and true negatives, critical for effective screening programs.
Implications for China and Beyond
China, with an estimated 476 million women of screening age, represents TruScreen’s largest market. The device is already included in key Chinese clinical guidelines, such as those from the Chinese Society for Colposcopy and Cervical Pathology (CSCCP) and the COGA Blue Book. The study’s findings are expected to reinforce TruScreen’s position in upcoming guideline updates, encouraging broader adoption in public health screening programs. Given the device’s suitability for low-resource settings; where traditional cytology and HPV testing infrastructure may be lacking; TruScreen is well positioned to address screening gaps in emerging markets globally.
A Step Towards WHO’s Cervical Cancer Elimination Goals
Globally, cervical cancer screening coverage remains uneven, with only 32% of women aged 30–49 screened in many countries, far below the World Health Organization’s 70% target for 2030. TruScreen’s rapid, AI-driven, and infrastructure-light technology offers a practical solution to increase screening rates, especially in low- and middle-income countries. CEO Marty Dillon emphasised the device’s potential to lead screening programs where conventional methods are impractical, marking a pivotal moment in the fight against cervical cancer.
Looking Ahead
With over 200 devices installed worldwide and more than 200,000 examinations conducted in the last financial year alone, TruScreen is gaining traction. The publication of this landmark study not only validates the technology’s clinical efficacy but also strengthens its commercial prospects. As TruScreen continues to expand its footprint in China and emerging markets, investors and healthcare stakeholders will be watching closely for the impact on screening program adoption and revenue growth.
Bottom Line?
TruScreen’s validated superiority sets the stage for wider adoption, but market uptake and guideline integration remain key to watch.
Questions in the middle?
- How quickly will Chinese and other emerging market guidelines formally integrate TruScreen following this study?
- What commercial impact will this validation have on TruScreen’s sales and device installations in 2026 and beyond?
- How will competitors in cervical cancer screening respond to TruScreen’s growing clinical validation and market presence?
