TruScreen Validated as Superior Primary Screening Tool

11/02/2026 08:30 NZDT, GENERALP

NZX/ASX Announcement

11 Feb 2026

TruScreen validated as Superior Primary Screening Tool

by World's largest Opto-Electronic Cervical Cancer Screening Study

• Landmark Chinese Obstetricians and Gynaecologists Association (COGA) clinical study results have been published by leading journal BMC Cancer and Springer Nature Link

• The 2018-2021 study, conducted in 64 hospitals, across 9 Provinces with 14,982 women, validates TruScreen as a superior primary cervical cancer screening tool over Liquid Based Cytology (LBC) and high-risk Human Papillomavirus (hrHPV) testing

• The trial is the largest ever study of opto-electronic screening conducted internationally, and is a significant milestone for TruScreen and the global cervical cancer screening community

TruScreen Group Limited (NZX/ASX: TRU), (“TruScreen” or “the Company”), a global leader in AI-enabled cervical cancer screening, is pleased to announce the publication of the largest ever study of opto-electronic screening conducted, validating TruScreen as a superior primary cervical cancer screening tool.

The study - “A real-world multicenter study on opportunistic cervical cancer screening in hospital in China: comparison of TruScreen device, cytology, and HPV testing for detecting high-grade cervical lesions” – was conducted by the Chinese Obstetricians and Gynaecologists Association (COGA) from 2018-2021, in 64 teaching hospitals across 9 provinces in China, with 14,982 women.

The full study, published by BMC Cancer, can be viewed on Springer Nature here: https://link.springer.com/article/10.1186/s12885-026-15590-6.

A summary of the GOGA study was previously presented by Professor Chen Fei at the American CSCCP conference in San Diego in April 2022. The major study was published after independent peer reviews.

The study compared TruScreen against Liquid Based Cytology (LBC) and high-risk Human Papillomavirus (hrHPV) testing for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+).

The results for detection of severe pre-cancerous lesions - cervical intraepithelial neoplasia (CIN) grade 2 and 3 showing superior sensitivity ( the detection of true positives) and negative predictive value (the absence of disease) to LBC and comparable to HPVDNA as shown below

CIN 2 Sensitivity TRU 87.0% LBC 66.4% HPV DNA 91.9%

CIN 2 Negative Predictive Value TRU 93.3% LBC 83.5% HPV DNA 91.9%

CIN 3 Sensitivity TRU 90.0% LBC 62.7% HPV DNA 91.3%

CIN 3 Negative Predictive Value TRU 97.9% LBC 92.4% HPV DNA 96.4%

The study’s authors concluded that

“Truscreen has the highest AUC (area under curve) for both CIN2+(0.72) and CIN3+(0.70), indicating it was the most accurate test overall…. The robust performance of the TS [TruScreen] test - validated against pathological findings in this study - provides solid data for future research in primary health centers and remote rural areas. This study demonstrates that the TruScreen (TS) test exhibits sensitivity, PPV, and RR comparable to hrHPV testing, supporting its potential integration into cervical cancer (CC) screening programs in China….”

China is TruScreen’s largest market, with an estimated 476 million women of screening age.* TruScreen has been included in the Chinese Society for Colposcopy and Cervical Pathology (CSCCP) guidelines and the Chinese Obstetricians and Gynaecologists Association (COGA) Blue Book since 2024. The Blue Book sets out a clinical reference guideline that summarises expert consensus, best-practice recommendations, and treatment standards for a specific area of women’s health care.

Following this landmark publication:

• The CSCCP will be issued with an ‘Expert Consensus for TruScreen’ and be requested to include this in the next update to its guidelines.

• The 2nd edition of the COGA Blue Book is due to be published in 2026 and these results will reinforce the current TruScreen reference

• The clear reference to TruScreen’s “potential integration into screening programs” will be impressed upon public health officials responsible with the conduct of major public screening programs in our largest market.

The publishing of these results by an internationally respected journal, the Springer BMC Cancer journal and the higher re-rating of TruScreen’s inclusions in the CSCCP and COGA guidelines will reiterate the medical efficacy and application of TruScreen’s technology over conventional screening methods to our China and global distributors. TruScreen has also been collaborating with a number of emerging markets to assist them with their development of public screening programs.

A recent review of 202 countries and territories estimated that the 5-year screening coverage in women aged 30–49 years was only 32%, with substantial disparities between high-income countries (HICs) and low- and middle-income countries (LMICs) (77% vs 24%).** The World Health Organization’s target is 70% screening coverage by 2030 – meaning there is a major screening gap which TruScreen is well suited to help close.

TruScreen CEO Marty Dillon comments:

“This publication represents a major highpoint and a milestone for TruScreen and our efforts to significantly lift screening rates globally to support WHO’s strategy to eliminate cervical cancer. TruScreen’s superiority as a primary screening method proven on such a large scale, together with the device’s particular suitability for emerging markets with low pathology infrastructure settings (where cytology and HPV DNA based screening is impractical), makes TruScreen ideal to lead screening programs as an alternative to conventional laboratory and infrastructure dependent methods.”

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* CIA World Factbook

** Bruni L, Serrano B, Roura E, et al. Cervical cancer screening programmes and age-specific coverage estimates for 202 countries and territories worldwide: a review and synthetic analysis. Lancet Glob Health. 2022;10:e1115–27. doi: 10.1016/S2214-109X(22)00241-8. [DOI] [PMC free article] [PubMed] [Google Scholar]

This announcement has been approved by the Board.

Ends

For more information, visit www.truscreen.com or contact:

Martin Dillon

Chief Executive Officer

martindillon@truscreen.com

Guy Robertson

Chief Financial Officer

guyrobertson@truscreen.com

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  1. TruScreen Validated as Superior Primary Screening Tool