TruScreen Maps NZ$4M Revenue Path in Global Expansion Update
TruScreen accelerates global expansion as world’s largest cervical screening study validates technology
TruScreen Group has delivered a comprehensive markets update confirming significant regulatory, clinical and commercial progress across Asia, Africa and Europe. The Chinese Society of Colposcopy and Cervical Pathology (CSCCP) Expert Consensus process is underway following publication of the COGA study results — the world’s largest opto-electronic cervical screening study involving 14,982 women across 64 hospitals in 9 provinces. Three UNITAID grant applications may add NZ$4 million to annual revenue from FY2028 to FY2030 across 14 countries, while India regulatory approval is expected within 3-6 months.
This update arrives in the context of the WHO’s 90-70-90 milestones requiring member nations to achieve 70% screening coverage by December 2030. The convergence of clinical validation, institutional funding applications and multi-country regulatory progress represents potential catalysts that could materially accelerate revenue growth from FY2027 onwards.
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What is an Expert Consensus and why does it matter for medical device adoption?
An Expert Consensus is an official clinical guidance document issued by a medical specialty society — in this case, CSCCP (the Chinese Society of Colposcopy and Cervical Pathology). It functions as a formal endorsement that influences prescribing behaviour, hospital procurement decisions and government reimbursement eligibility.
The Chinese Obstetricians and Gynaecologists Association (COGA) has requested CSCCP to issue an Expert Consensus specific to TruScreen. Once issued, this removes a key adoption barrier: clinicians can reference the Consensus when recommending TruScreen over traditional Pap tests or HPV testing.
Expert Consensus documents carry significant weight in China’s healthcare system. This represents a formal pathway to inclusion in government-funded national and regional population screening programs in the world’s largest cervical cancer market (more than 150,000 new cases annually).
Clinical validation — TruScreen outperforms traditional screening methods
The COGA study, published in BMC Cancer on Springer Nature Link in February 2026, validates TruScreen as a superior primary cervical cancer screening tool compared with liquid-based cytology (LBC/Pap test) and high-risk human papillomavirus (hrHPV) testing.
The COGA study validation confirmed TruScreen achieved the highest accuracy of all tests evaluated for CIN2+ and CIN3+ detection, a result that transforms the technology’s clinical positioning from manufacturer claims to independently verified procurement-grade evidence.
| Metric | TruScreen | LBC (Pap test) | HPV Testing |
|---|---|---|---|
| Sensitivity | 87.5% | 66.5% | — |
| Specificity | 88.4% | 86.3% | 78.3% |
The sensitivity of TruScreen-HPV co-testing was 98.4% versus 95.9% for LBC-HPV co-testing. These results position TruScreen as clinically superior to incumbent technologies, particularly for primary screening in underserved regions where laboratory infrastructure is limited.
Supporting studies reinforce this positioning. A Sichuan University clinical study (n=297) showed that TruScreen + hr-HPV demonstrated superior diagnostic performance and accuracy versus cytology-based co-testing. The Guilin People’s Hospital study supported TruScreen’s clinical value as a preferred screening option for pregnant women.
The COGA study determined TruScreen to be an appropriate primary cervical cancer screening tool in regions with high morbidity and mortality to cervical cancer. China’s regional disparities are large, with rural and western provinces carrying higher burdens and lower screening access.
Global funder pipeline could add NZ$4 million in annual revenue
Three grant applications have been submitted to UNITAID to screen 400,000-500,000 women over 3 years across 14 countries. Target regions include Africa (Zimbabwe, South Africa, Eswatini, Rwanda, Nigeria, Kenya) and Asia/Latin America (China, India, Indonesia, Vietnam, Uzbekistan, Mexico, Malaysia, Thailand).
Implementation partners include:
- PATH (Program for Appropriate Technology in Health) — Global technical partner
- National AIDS Council (Zimbabwe) — Country implementation lead
- Solina Centre for International Development and Research (SCIDaR) — Implementation partner (Nigeria)
- RedAid Nigeria — Community health delivery and outreach
- Baylor College of Medicine Children’s Foundation Eswatini — Implementation partner
TruScreen is technology partner in five UNITAID grant applications total, including two with global NGOs.
A separate application was submitted to the Bill & Melinda Gates Foundation in April 2026 with Nigeria’s Lagos State University Teaching Hospital (LASUTH) and Lagos State University College of Medicine (LASUCOM). Dr Ayokunle Moses Olumodeji, Consultant Gynaecological Oncologist at LASUTH, selected TruScreen’s AI-enabled cervical cancer screening device as the cornerstone of his proposed study to validate its integration into existing clinical settings.
The Clinton Health Access Initiative has confirmed receipt of TruScreen’s US$700,000 application for AI-enabled screening in Africa.
Investors exploring the funding pipeline in detail can find our full explainer on TruScreen’s UNITAID proposals, which covers the consortium structure, the NZ$4 million annual revenue projection methodology, and the November 2026 decision timeline across all three applications.
If successful, these applications represent a step-change in revenue visibility. Institutional funding from organisations like UNITAID and the Gates Foundation provides multi-year contracted demand independent of individual country sales cycles.
Asia Pacific expansion — India approval imminent, Vietnam government discussions underway
India
An application for regulatory approval was submitted in April 2026, with approval expected within 3-6 months. 10 devices were shipped following the appointment of distributor Renovate Biologicals Pvt Ltd in April 2025 and an interim product testing licence issued in July 2025. A consortium of private hospitals is evaluating adoption upon receipt of regulatory approval.
India has the world’s second-largest cervical cancer burden, with over 127,000 new cases annually and a disproportionately high share of deaths. Mortality remains high because many women are diagnosed late, due to extremely low screening rates (2% nationally, with regional variance). China and India accounted for 42% of cervical cancer cases in 2022.
Vietnam
TruScreen and its distributor GHS are in discussions with the Ho Chi Minh City government regarding the use of TruScreen in the city-wide health check-up program launched by the Health Department in April 2026. The second phase of the program will include cervical screening, and GHS believes TruScreen is well positioned for selection, particularly as the program expands into rural areas where laboratory facilities for Pap and HPV testing are limited.
GHS participated in the Smart Healthcare Exhibition in April, where TruScreen attracted strong interest and positive feedback. The first private hospital has integrated TruScreen into its clinical operations, while a further seven hospitals are pending government approval for installation.
Thailand, Malaysia and Singapore
Product registration with Thailand’s FDA was obtained in April 2026. Product registration in Malaysia was submitted in March 2026, with approval expected in Q2 FY2027.
In Singapore, prominent key opinion leader Dr S. C. Quek has installed TruScreen at his Parkway Gynaecology Screening & Treatment Centre, Gleneagles Hospital. This clinic will serve as a key TruScreen reference centre for South East Asia.
Africa strategy gains momentum with Zimbabwe screening programs and Nigeria reference centre
Preparation is underway for the first of the 10,000 women TruScreen Ultra screening programs planned for Zimbabwe for FY2027. The Ministry of Health has approved extending from one province to nationwide screening following positive re-validation study results.
Distributor Southern Skies Medical participated in the Zimbabwe Inaugural Reproductive, Maternal, Newborn, Child and Adolescent Health and Nutrition (RMNCAH+N) Conference 2026 in March. The TruScreen booth attracted more than 50 visitors, including the Health Minister, who spent 15 minutes reviewing the features and benefits of TruScreen, with positive feedback.
The first African clinical reference centre is planned to be established in Nigeria with Professor Chibuike Chigbu at the University of Nigeria Teaching Hospital in June 2026. Professor Chigbu has received TruScreen Ultra devices and Single Use Sensors to conduct a pilot clinical study at his centre in support of market entry in Nigeria. This program will commence in July 2026.
Product registration with the South African Health Products Regulatory Authority (SAHPRA) was submitted in March 2026, with approval expected in July 2026.
Zimbabwe faces an extremely high burden, worsened by high HIV prevalence, which substantially increases cervical cancer risk (a challenge faced by much of sub-Saharan Africa). Nigeria has one of the highest cervical cancer burdens in the world, with HIV prevalence in some populations also contributing to risk. South Africa has a very high cervical cancer burden despite relatively advanced medical infrastructure compared with many African countries.
The combination of government endorsement in Zimbabwe, reference centre establishment in Nigeria, and pending South Africa registration positions TruScreen for multi-country adoption across sub-Saharan Africa.
Emerging markets and Europe — building the distribution network
Bangladesh
Xerox Medica Limited was appointed distributor in May 2026, with projected first-year sales revenue of NZ$554,000. A government procurement application is being submitted in late June 2026 to meet the government budget deadline.
Bangladesh carries a very high cervical cancer burden, from limited screening access, low awareness, and constrained oncology infrastructure. Like India, most women present with advanced disease.
Uzbekistan
Albatros Health Care LLC, a leading medical device distributor, was appointed as TruScreen’s distributor in May 2026. Potential revenue for the 30-month period through calendar year 2028 is NZ$1.27 million.
Following ethics approval, Professor Pakhomova, President of the Association of Obstetricians and Gynaecologists of Uzbekistan, will conduct a pilot clinical study in Tashkent. The study will commence in early July 2026. TruScreen Ultra devices and Single Use Sensors are in transit to Uzbekistan to commence this program.
Sri Lanka
Product registration is almost completed, and discussions regarding sales and marketing plans commenced in May 2026. Sri Lanka has an estimated 7.4 million women of screening age, representing significant market opportunity.
Central Asia
Distributor IMSystem is conducting a multi-centre clinical study to support recognition of TruScreen as a primary screening method across government healthcare providers and screening programs. Two key women’s health centres began screening 1,500 women in April, with two additional centres commencing in May 2026 to screen a remaining 500 women.
Product registrations have been submitted in Kyrgyzstan and Belarus, with approvals expected in Q3 FY2027.
Italy
A product introduction meeting was held at Borgo Trento Hospital in Verona in February 2026. 10 senior managers and professors from the hospital, the University of Verona and AIRC (Italian Association for Cancer Research) attended, and feedback was positive.
Following that meeting, distributor Chinni engaged AIRC to conduct a pilot clinical study to gain acceptance from local doctors and government policymakers. The protocol is to screen 650 to 800 women and compare TruScreen with the current screening methods.
Following expected favourable results, AIRC will support installation of TruScreen across the 17 committees it operates, with an estimated two to three devices per committee and approximately 40 screenings per device per month. This could result in up to 50 TruScreen Ultra devices being installed using 24,000 Single Use Sensors per annum. AIRC is awaiting ethics approval to commence the study.
Italy has an estimated 18.6 million women of screening age, representing a significant market opportunity.
Additional markets
TruScreen is in discussions with distributors in Rwanda, Palestine and Jordan. The company is working with Austrade’s African offices to accelerate market entry to Africa. The first group of countries includes Kenya and Tanzania.
The breadth of distributor appointments and regulatory submissions demonstrates TruScreen’s systematic approach to building a global distribution network ahead of the WHO 2030 deadline.
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Investment thesis — multiple near-term catalysts as WHO deadline approaches
TruScreen has transitioned from clinical validation to commercial execution phase. Key catalysts over the next 12 months include:
- CSCCP Expert Consensus issuance — Process underway; timing not specified
- India regulatory approval — Expected within 3-6 months
- UNITAID grant decisions — Screening 400,000-500,000 women across 14 countries
- Zimbabwe nationwide screening program rollout — First of 10,000 women programs planned for FY2027
- South Africa SAHPRA approval — July 2026
- Multiple pilot studies commencing — Uzbekistan (July 2026), Nigeria (July 2026), Italy (pending ethics)
The WHO 90-70-90 deadline context creates structural demand: 194 member nations must achieve 70% screening coverage by December 2030. TruScreen’s point-of-care, AI-enabled device addresses the infrastructure limitations that prevent traditional Pap and HPV testing in low and middle-income countries.
The convergence of regulatory approvals, institutional funding applications and government program discussions represents a potential inflection point for revenue growth. TruScreen is well positioned to serve regions with high morbidity and mortality to cervical cancer, where traditional screening methods face deployment constraints.
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