TruScreen Study Shows Superior Cervical Screening vs Cytology Methods

Peer-reviewed study confirms TruScreen outperforms cytology-based screening

TruScreen Group Limited (ASX: TRU) has announced the publication of an independent clinical study demonstrating the superiority of its TruScreen hr-HPV co-testing approach over conventional cytology-based screening methods. The peer-reviewed study, published in the Journal of Sichuan University (Medical Science Edition) and indexed on PubMed, screened 297 women aged 21 to 57 years at Panzhihua Central Hospital between June 2020 and December 2023.

The research compared the diagnostic performance of TruScreen combined with high-risk human papillomavirus (hr-HPV) testing against Thinprep cytology test (TCT) combined with hr-HPV testing for detecting cervical lesions. The study’s publication adds independent clinical validation to TruScreen’s technology, supporting the company’s regulatory submissions and commercial partnerships across its 29-country distribution network.

Study results favour TruScreen technology

The study identified 128 LSIL+ cases (43.10%) and 67 HSIL+ cases (22.56%) among participants. TruScreen combined with hr-HPV testing achieved a significantly higher area under the ROC curve (AUC) than TCT combined with hr-HPV for both low-grade squamous intraepithelial lesion positive (LSIL+) and high-grade squamous intraepithelial lesion positive (HSIL+) cervical lesions, with statistical significance confirmed at P < 0.05.

The AUC is a statistical measure that evaluates diagnostic accuracy. A higher AUC indicates better ability to distinguish between patients with and without cervical abnormalities. TruScreen’s superior AUC demonstrates improved diagnostic performance compared to the cytology-based approach.

The study reported that TruScreen combined with hr-HPV delivered high sensitivity for HSIL+ lesions whilst demonstrating improved specificity and negative predictive value compared with TCT combined with hr-HPV. Specificity measures a test’s ability to correctly identify patients without disease, whilst negative predictive value indicates the probability that a patient with a negative test result truly does not have the condition.

The study authors concluded:

Study Authors’ Conclusion

“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.”

This conclusion supports the potential for TruScreen technology to replace traditional cytology-based screening in markets where pathology infrastructure is limited or where real-time diagnostic results are prioritised.

Understanding cervical cancer screening methods

Cervical cancer screening methods differ in how they detect abnormal cells and assess cancer risk. Understanding these differences helps explain why TruScreen’s approach offers distinct advantages in certain clinical settings.

Traditional cytology-based methods:

• Pap smear: Collects cervical cells using a brush, places them on a glass slide, and sends the sample to a laboratory where a pathologist examines it under a microscope
• Liquid-based cytology (LBC/TCT): Transfers a thin layer of cervical cells onto a slide after removing blood or mucus, preserving the sample for additional testing such as HPV detection
• Both methods require specialised cytology laboratories and trained cytologists to analyse results, creating delays between sample collection and diagnosis

hr-HPV testing:

• Detects high-risk strains of human papillomavirus, the primary cause of cervical cancer
• Can be performed on the same sample used for cytology tests
• Often combined with cytology (co-testing) to improve detection accuracy

TruScreen’s opto-electronic technology:

• Uses low-level optical and electrical stimuli to detect cervical tissue abnormalities in real time
• Provides immediate results at the point of care without requiring laboratory processing
• Does not require specialist cytologists or supporting laboratory infrastructure
• When combined with hr-HPV testing, offers a co-testing strategy that eliminates cytology-based processing

Diagnostic performance metrics:

• Sensitivity: The ability to correctly identify patients with cervical abnormalities (minimising false negatives)
• Specificity: The ability to correctly identify patients without cervical abnormalities (minimising false positives)
• AUC (Area Under the ROC Curve): A comprehensive measure of diagnostic accuracy, ranging from 0.5 (no better than chance) to 1.0 (perfect classification)

TruScreen’s technology addresses key limitations of cytology-based methods by eliminating sample processing delays, reducing dependency on laboratory infrastructure, and providing immediate diagnostic feedback during patient consultations.

Building the clinical evidence base

The Sichuan University study adds to TruScreen’s expanding body of clinical validation, which now comprises more than 30 trials and large studies involving over 40,000 women worldwide. This cumulative evidence base supports regulatory approvals, guideline inclusion, and commercial partner confidence across diverse healthcare markets.

The most significant validation came in February 2026 with the publication of the landmark COGA study in Germany’s BMC Cancer journal. This study screened 14,982 women, representing the world’s largest opto-electronic cervical cancer screening study. The COGA study confirmed TruScreen’s superiority as a primary screening tool compared with liquid-based cytology and hr-HPV testing, establishing a benchmark for the technology’s clinical performance.

TruScreen’s real-time, point-of-care capabilities eliminate several practical barriers to screening programme implementation. The technology does not require cytology laboratories, specialist cytologists, or sample transportation infrastructure. In financial year 2024 alone, over 200,000 examinations were performed with the TruScreen device across its global installed base of more than 200 devices in China, Vietnam, Mexico, Zimbabwe, Russia, and Saudi Arabia.

Strategic partnership validation

The Sichuan University study provides additional validation for TruScreen’s strategic partnership with Dalton BioSciences, a leading Chinese manufacturer of HPV in vitro diagnostic (IVD) products. The study demonstrates the effectiveness of combining TruScreen’s opto-electronic technology with hr-HPV testing, supporting the distribution of Dalton’s HPV IVD products through TruScreen’s global distribution network.

Executive Chairman Tony Ho commented on the strategic significance:

Tony Ho, Executive Chairman

“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.”

The partnership positions TruScreen to offer a complete co-testing solution that combines real-time opto-electronic screening with HPV detection, addressing both technical performance and practical implementation requirements in resource-constrained healthcare settings.

Global market positioning and regulatory footprint

TruScreen has established a regulatory and commercial footprint across 29 countries, supported by key approvals and guideline recognitions that reduce barriers to adoption in target markets. The company’s regulatory strategy focuses on markets where limited pathology infrastructure creates demand for point-of-care screening technologies.

Regulatory approvals:

• CE Marked/EC certified (European Union)
• TGA registered (Australia)
• MHRA registered (United Kingdom)
• NMPA registered (China)
• SFDA registered (Saudi Arabia)
• Roszdravnadzor registered (Russia)
• COFEPRIS registered (Mexico)
• Ministry of Health approvals in Vietnam, Israel, Ukraine, and the Philippines

Guideline recognition:

• China: Included in the Chinese Society for Colposcopy and Cervical Pathology (CSCCP) China Cervical Cancer Screening Management Guidelines and the COGA Blue Book
• Vietnam: Added to the Ministry of Health approved National Technical List in December 2023 for use in public and private healthcare sectors
• Russia: Added to national guidelines for cervical cancer screening in 2024

These guideline inclusions represent critical milestones for commercial adoption. In many healthcare systems, clinical guidelines directly influence reimbursement decisions, procurement policies, and practitioner adoption patterns. Recognition in national screening protocols validates TruScreen’s technology within evidence-based care pathways.

The company’s regulatory footprint positions it to serve markets characterised by growing screening demand but limited cytopathology capacity. This includes emerging markets in Southeast Asia, Latin America, Africa, and parts of Eastern Europe where traditional laboratory-based screening faces infrastructure and cost barriers.

Next steps and commercial outlook

The publication of the Sichuan University study supports TruScreen’s ongoing commercial expansion by providing peer-reviewed evidence of diagnostic superiority in a co-testing framework. This evidence strengthens the company’s position in regulatory submissions, guideline inclusion discussions, and partnership negotiations across its target markets.

The study’s validation of TruScreen combined with hr-HPV testing directly supports the commercialisation strategy linked to the Dalton BioSciences partnership. As the Dalton HPV IVD products are distributed through TruScreen’s network, the published evidence provides clinical justification for co-testing adoption in markets prioritising point-of-care solutions.

TruScreen’s commercial focus remains on markets where access to pathology infrastructure is limited, where screening coverage rates are suboptimal, or where healthcare systems seek to reduce laboratory processing costs. The combination of regulatory approvals, guideline recognition, and peer-reviewed clinical evidence positions the company to capture market share in these segments as screening programmes expand.

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