Sichuan University clinical study confirms superiorityof TruScreen + hr-HPV co-testing

Market AnnouncementClinical Performance
Written By Anna Large
Read the NZX Announcement

  • 297-patient study was published and peer-reviewed in Journal of Sichuan University

  • TruScreen combined with hr-HPV testing confirmed superior performance in cervical cancer screening compared with Thinprep cytology test (TCT) combined with hr-HPV test

  • Study provides further validation for the use of Dalton BioSciences HPV IVD test with TruScreen’s opto-electronic technology for distribution through TruScreen’s global distribution network

TruScreen Group Limited (NZX/ASX: TRU) (“TruScreen” or “the Company”), a global leader in AI-enabled cervical cancer screening, advises that an independent clinical study comparing TruScreen with Thinprep cytology test (TCT), and in combination with high-risk human papillomavirus (hr-HPV) testing, has been published and peer-reviewed in Journal of Sichuan University (Medical Science Edition). 

The study can be accessed in Journal of Sichuan University here: TruScreen联合高危HPV检测与液基细胞学联合HPV检测在宫颈癌筛查中的对比研究, or on PubMed here: https://pubmed.ncbi.nlm.nih.gov/40964107/  

The study, titled “TruScreen Combined With High-Risk Human Papillomavirus Testing vs Thinprep Cytology Test Combined With High-Risk Human Papillomavirus Testing for Cervical Cancer Screening: A Comparative Clinical Study”, screened 297 women (21 to 57 years old) at Panzhihua Central Hospital between June 2020 and December 2023. 

The primary objective was to compare the diagnostic performance of TruScreen + hr-HPV co-testing, and TCT + hr-HPV co-testing, for the detection of low-grade squamous intraepithelial lesion positive (LSIL+) and high-grade squamous intraepithelial lesion positive (HSIL+) cervical lesions.

 

Results

  • Histopathology identified 128 LSIL+ cases (43.10%) and 67 HSIL+ cases (22.56%) in the study

  • TruScreen + hr-HPV achieved a significantly higher area under the ROC curve (AUC) than TCT + hr-HPV for both LSIL+ and HSIL+ (P < 0.05).

  • TruScreen + hr-HPV delivered high sensitivity for HSIL+ lesions with improved specificity and negative predictive value compared with TCT + hr-HPV.

  • Overall, TruScreen + hr-HPV showed superior diagnostic performance and accuracy versus the cytology-based co-testing algorithm.

The authors concluded that:

“TruScreen combined with hr-HPV demonstrates superior performance in cervical cancer screening compared with TCT combined with hr-HPV test and may serve as an alternative to conventional cytology-based methods in China.”

Strategic and clinical significance

This publication adds to TruScreen’s expanding clinical evidence base, which now comprises more than 30 trials and large studies involving over 40,000 women worldwide. The findings are consistent with the Company’s larger clinical evaluations, including the landmark COGA study of 14,982 women – the world’s largest opto-electronic cervical cancer screening study - published in February 2026 in Germany’s BMC Cancer and confirming TruScreen’s superiority as a primary screening tool compared with liquid-based cytology and hr-HPV testing.

This 297-patient study provides additional evidence in support of TruScreen + hr-HPV co-testing strategies, demonstrating performance advantages over TCT + hr-HPV while utilising TruScreen’s real-time, point-of-care, AI-enabled technology that does not require cytology laboratories or specialist cytologists.

TruScreen Executive Chairman Tony Ho comments:

“These results continue to support TruScreen’s suitability for integration into cervical cancer screening initiatives globally, particularly in markets where access to pathology  infrastructure is limited. They also further validate the company’s strategic partnership with Dalton BioSciences, a leading Chinese manufacturer of HPV test kits, to distribute HPV IVD products through TruScreen’s global distribution network.” 

This announcement has been approved by the Board.

Anna Large
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