TruScreen FY2026 Preliminary Results
(all numbers in NZ dollars)
Cervical cancer technology company Truscreen Group Limited (NZX/ASX: TRU) (the Company) has today released its preliminary unaudited financial results for the financial year ended 31 March 2026.
Highlights include:
Launch of 5-year programme to screen 260,000 women for cervical cancer in Ho Chi Minh City, Vietnam
TruScreen re-enters the Indian market and appoints Renovate Biologicals Pvt Ltd to distribute its AI enabled TruScreen cervical cancer screening system in India
Landmark publication of the multi year and multi province clinical trial by Germany’s BMC Cancer. Notable publications including Sichuan University clinical study, and the Guilin People’s Hospital study, confirm TruScreen’s superiority as a primary screening medical device, and a superior screening choice for pregnant women
TruScreen submitted three proposals to UNITAID's Global Cervical Cancer Elimination Call to Action, covering 14 high burden countries and an addressable screening market of 1Bn women.
Growing TruScreen’s distribution network with appointment of new distributors in South Africa and Uzbekistan, with pending appointments in Nigeria, Romania, Bangladesh and Sri Lanka
Financial year 31 March 2026 was a year of marketing growth and consolidation for TruScreen.
Truscreen achieved product sales growth of 42% YOY to FY2026, and the sales were achieved from a broader range of participant countries. This included first sales in India with 468 million* screening-age women and Indonesia with 95 million* of screening age and a government funded mass screening program, creating enormous growth opportunity.
TruScreen is accelerating new market development, with a diversified geographic distribution footprint that will provide leverage to improve commercial returns. TruScreen’s additional drive to participate in public screening programmes requires investment, but achieving scale and meeting clinical need will shorten the pathway to profitability.
TruScreen has recently submitted three proposals to UNITAID for cervical cancer screening programmes across 14 high-burden countries in Africa, Asia-Pacific, and Latin America – addressable market 1Bn women, with potential revenue as a consortium lead for TruScreen of up to US$18.4 million. TruScreen’s point-of-care portable AI technology is purpose-built for the settings where cervical cancer kills most, where there are no laboratories, no pathologists, and no patient recall second visit.
TruScreen enables primary screening where labs are absent, HPV triage where HPV (including Dalton Bio) is primary, and same-visit complement in screen-and-treat settings. This creates a complementary rather than competitive relationship with HPV expansion.
Gross margin in FY2026 was 31.5% (2025: 30.1%). Gross margin is expected to further improve in FY2027 with revenue from a broader range of countries. Other income was in line with the prior year at $0.4m (2025: $0.4m).
Total overhead expenses were $3.4m (2025: $3.1m) reflecting additional marketing and support costs as the Company strives to broaden its revenue base. The result for the year was a loss of $2.25m (2025: $2.24m) with the additional margin on revenue being offset by additional costs incurred as the Company grew its distributor base and focus on large public screening programmes in collaboration with global NGO’s working with countries to meet WHO’s 90-70-90 milestones by 2030.
TruScreen in FY2026 expanded its reach into a number of new countries. A brief summary of development by country is as follows:
China
China remained our largest market, accounting for 61.3% of total sales. Despite challenging economic conditions, consumable sales volume met expectations.
Landmark clinical study results from the Chinese Obstetricians and Gynaecologists Association (COGA) were published in the leading German journal BMC Cancer and Springer Nature Link in February 2026. This largestever study of opto-electronic cervical screening further validated TruScreen as a superior primary cervical cancer screening tool.
Vietnam
TruScreen was successfully adopted by four leading public hospitals in South Vietnam, establishing a foundation for broader hospital acceptance.
TruScreen has entered the growing private health sector. One hospital has integrated TruScreen into its daily clinic operations, while four additional clinics are awaiting government approval for installation and three more are preparing their application documentation for submission.
Indonesia
The pilot clinical study is currently underway. Results will be presented by the lead investigator at the Annual Scientific Meeting of POGI (the Indonesian Obstetrics and Gynaecology Association) in July 2026. TruScreen and distributor Marwa Mitra Medika are sponsoring the conference and will conduct a symposium to launch TruScreen in Indonesia.
Leveraging the pilot clinical study results, Marwa Mitra Medika will collaborate with the Ministry of Health to include TruScreen in government public screening programs.
India
New distributor Renovate Biological was appointed in April 2025.
Interim Product Testing license was obtained in July 2025, permitting Renovate Biological to import up to 10 TruScreen devices, which have been shipped, for clinical study and training purposes. A consortium of private hospitals will adopt TruScreen subject to regulatory approval.
Application for regulatory approval was submitted in April 2026, with approval expected within 3 to 6 months.
Singapore, Malaysia and Thailand
Product registration with Singapore's HSA was obtained in September 2025.
Product registration with Thailand's FDA was obtained in April 2026.
Product registration in Malaysia was submitted in March 2026, with approval expected shortly.
A reference centre for S E Asia has been established in Singapore with local Key Opinion Leader, Dr. S. C. Quek at the Parkway Gynaecology Screening & Treatment Centre, Gleneagles Hospital.
Bangladesh
New distributor Xerox Medica Limited was appointed in May 2026, with potential first-year sales in FY2027.
Government procurement application to be submitted in June 2026 to meet government budget deadline.
Mexico
Distributor Sunbird launched social media and digital marketing campaigns, established online training and information centres for TruScreen. It generated significant interest, and is building a strong sales pipeline.
TruScreen has entered the laboratory system where large volumes of cervical cancer screenings are conducted.
Sunbird is in discussions to collaborate with major laboratory chains. Sales are expected to commence in FY2027.
Uzbekistan
New distributor appointed in May 2026. Albatros Health Care LLC is a leading medical device distributor in the country. The potential sales revenue for the 30-month period through calendar year 2028 is over NZD 1 million.
Led by a senior government medical advisor, and with ethics approval, the pilot Clinical study will commence in June 2026.
Central Asia
Distributor IMSystem is conducting a multi-centre clinical study to meet requirements for TruScreen to be recognized as a primary screening method in all government healthcare providers and screening programs. Two centres have begun screening 1,500 women, with two additional centres commencing in May 2026 to screen the remaining 500 women.
Kazakhstan will commence commercial use of TruScreen in early FY2027. Product registrations have been submitted in Kyrgyzstan and Belarus, with approvals expected in Q3 FY2027.
Zimbabwe
The re-validation study was completed by the National Microbiology Reference Laboratory in August 2025. The positive results enabled the Ministry of Health to approve TruScreen as a primary screening test for locations where HPV DNA testing is unavailable and as a confirmatory test for HPV-positive women nationwide. This is an expansion from the previous single-province deployment.
Following re-validation, the screening program resumed with a planned 20,000 screenings in calendar year 2026.
South Africa
New distributor AIR was appointed in November 2025.
Product registration with the South African Health Products Regulatory Authority (SAHPRA) was submitted in March 2026, with approval expected in July 2026.
A pilot clinical study to support market entry has been planned to commence when regulatory approval is received.
Nigeria
TruScreen collaborated with Nigeria's Lagos State University Teaching Hospital (LASUTH) and Lagos State University College of Medicine (LASUCOM) on a Bill & Melinda Gates Foundation grant application. Dr. Ayokunle Moses Olumodeji, Consultant Gynaecological Oncologist at LASUTH, selected TruScreen's AIenabled cervical cancer screening medical device as the cornerstone of his proposed study to validate TruScreen's integration into existing clinical settings.
The first clinical reference centre in Africa will be established in Nigeria with Professor Chibuike Chigbu at University of Nigeria Teaching Hospital.
Collaborative relationships have been developed with local NGOs including Solina Centre for International Development and Research (SCIDaR) and RedAid.
Other new distributors appointed include Romania and Italy. We are in final discussions with potential distributors in Nigeria, Rwanda, Sri Lanka, and Palestine.
Corporate
The Company raised approximately $4 million during the year, with the issue of approximately 190.7 million shares at $0.022 per share. These funds have enabled the Company to expand its geographic reach and engage in new initiatives which have strengthened the foundation for improved financial performance in FY2027.
Attached to these shares is one free attaching option, exercisable at $0.022, which term has been extended to 17 July 2027.
Ms Juliet Hull retired as a director at the annual shareholders meeting on 11 September and Ms Christine Pears was elected by shareholders as a director. She has over 20 years’ experience as Chair, independent director and executive of both listed and private companies.
Our CEO, Martin Dillon, as foreshadowed in an announcement in February 2026, will rejoin the Company on 1 June 2026 and will be key in TruScreen’s drive for transformational growth.
Mr Chris Horn, as advised in early April 2026 will retire shortly after thirteen years as a director of the Company. The Company is currently seeking to appoint an Australian based Non-executive director.
*CIA World Factbook women, aged 15-64