TruScreen Group (ASX: TRU) has secured peer-reviewed validation of its cervical cancer screening technology through the TruScreen Cervical Cancer Screening Study, the largest opto-electronic screening trial ever conducted internationally. The landmark study, published by BMC Cancer and Springer Nature Link, involved 64 hospitals across 9 provinces in China and 14,982 women between 2018 and 2021, validating TruScreen as a superior primary screening tool over Liquid Based Cytology (LBC).
TruScreen validated as superior screening tool in world’s largest opto-electronic cervical cancer study
The Chinese Obstetricians and Gynaecologists Association (COGA) conducted the study comparing TruScreen against established screening methods. Results demonstrate TruScreen’s clinical performance exceeds that of LBC and achieves comparability with high-risk Human Papillomavirus (hrHPV) testing for detecting cervical intraepithelial neoplasia grade 2 or higher (CIN2+), which represents severe pre-cancerous lesions requiring intervention.
The TruScreen Cervical Cancer Screening Study represents a critical validation milestone for the company’s AI-enabled technology platform. Independent peer review and publication in an internationally recognised medical journal provides third-party clinical evidence supporting TruScreen’s positioning as a primary screening alternative in markets where traditional laboratory-dependent methods face infrastructure constraints.
Clinical results: sensitivity and detection rates explained
The study measured two critical screening performance metrics. Sensitivity indicates how effectively a test detects true disease cases, reducing the risk of missed diagnoses. Negative Predictive Value measures confidence that a negative result genuinely indicates absence of disease. Higher sensitivity directly reduces false negatives, the primary clinical risk in cervical cancer screening programmes.
| Metric | TruScreen | LBC | HPV DNA |
|---|---|---|---|
| CIN2 Sensitivity | 87.0% | 66.4% | 91.9% |
| CIN2 Negative Predictive Value | 93.3% | 83.5% | 91.9% |
| CIN3 Sensitivity | 90.0% | 62.7% | 91.3% |
| CIN3 Negative Predictive Value | 97.9% | 92.4% | 96.4% |
TruScreen achieved the highest area under curve (AUC) scores for both CIN2+ (0.72) and CIN3+ (0.70), indicating superior overall accuracy compared to both LBC and hrHPV testing. For CIN3 detection specifically, TruScreen demonstrated 90.0% sensitivity compared to LBC’s 62.7%, representing a 27.3 percentage point performance advantage in detecting the most severe pre-cancerous lesions.
What the study authors concluded
The study’s findings validate TruScreen’s performance against pathological confirmation, the clinical gold standard for cervical screening accuracy. Study authors specifically noted the technology’s suitability for settings where traditional screening infrastructure is limited or unavailable.
COGA Study Authors
“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 centres 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 programmes in China.”
The authors’ specific reference to “potential integration into screening programmes” provides clinical endorsement for TruScreen’s use in organised public health screening initiatives.
China market implications and guideline positioning
China represents TruScreen’s largest addressable market, with an estimated 476 million women of screening age. The company secured inclusion in the Chinese Society for Colposcopy and Cervical Pathology (CSCCP) guidelines and the COGA Blue Book during 2024. The Blue Book serves as a clinical reference document consolidating expert consensus and best-practice recommendations for women’s healthcare providers across China.
The peer-reviewed publication triggers three near-term commercial catalysts:
- The CSCCP will receive an ‘Expert Consensus for TruScreen’ document and be formally requested to incorporate this consensus into its next guideline update cycle.
- The second edition of the COGA Blue Book, scheduled for publication in 2026, will incorporate the study results to reinforce TruScreen’s existing reference status.
- Study findings explicitly referencing TruScreen’s “potential integration into screening programmes” will be presented to public health officials overseeing major national and provincial screening initiatives in China.
Enhanced guideline positioning directly supports commercial discussions with provincial health authorities and hospital networks evaluating screening technology procurement decisions. The combination of guideline inclusion and published clinical validation addresses two critical procurement criteria: clinical efficacy evidence and expert endorsement.
Global screening gap and TruScreen’s strategic positioning
A recent review covering 202 countries and territories revealed 5-year screening coverage for women aged 30 to 49 years reached only 32% globally. This aggregate figure masks substantial disparity between high-income countries (77% coverage) and low and middle-income countries (24% coverage).
The World Health Organization’s cervical cancer elimination strategy targets 70% screening coverage by 2030. Closing the gap between current coverage (32%) and the WHO target (70%) requires an additional 38 percentage points of global screening penetration within four years.
TruScreen’s technology platform addresses infrastructure constraints limiting screening expansion in emerging markets:
- No laboratory requirement: Results delivered in real-time during clinical examination, eliminating sample transport and processing delays.
- No specialised pathology staff: Reduces dependency on scarce cytology and pathology expertise.
- Immediate clinical decision-making: Positive results enable same-visit referral for colposcopy, eliminating patient follow-up compliance issues.
- Lower infrastructure cost: Removes requirements for cold-chain sample preservation and laboratory processing facilities.
The company is currently collaborating with multiple emerging market health authorities on public screening programme development, leveraging the TruScreen Cervical Cancer Screening Study results as clinical validation for technology selection discussions.
CEO perspective on the milestone
TruScreen Chief Executive Officer Marty Dillon positioned the publication as validating the company’s strategic approach to addressing global screening coverage gaps through technology suited to low-infrastructure environments.
Marty Dillon, CEO
“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 programmes as an alternative to conventional laboratory and infrastructure dependent methods.”
The CEO’s emphasis on “low pathology infrastructure settings” aligns with the company’s commercial focus on markets where conventional screening faces structural barriers to deployment.
Investment thesis: why this validation matters
The TruScreen Cervical Cancer Screening Study transforms the company’s clinical positioning from manufacturer claims to independently validated evidence published in a peer-reviewed medical journal. This validation addresses a critical requirement for distributors negotiating with public health authorities and hospital networks evaluating screening technology procurement.
TruScreen’s existing commercial footprint demonstrates technology adoption across diverse regulatory and healthcare environments. The company performed over 200,000 examinations with its TruScreen device during FY2024. To date, over 200 devices have been installed and used across six countries: China, Vietnam, Mexico, Zimbabwe, Russia, and Saudi Arabia. The company maintains distributor relationships across 29 countries globally.
Near-term catalysts include guideline updates incorporating the study results (CSCCP guidelines and 2026 COGA Blue Book edition) and engagement with Chinese public health officials regarding “potential integration into screening programmes” as explicitly referenced by study authors. These institutional endorsements strengthen commercial discussions with distributors and health authorities evaluating screening programme technology selections.
The substantial gap between current global screening coverage (32%) and WHO’s 2030 target (70%) represents a 38 percentage point expansion requirement, concentrated primarily in low and middle-income countries where TruScreen’s infrastructure-light approach provides competitive differentiation against laboratory-dependent alternatives.
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