TruScreen Validated by Largest Study as Global Expansion Accelerates

World’s Largest Study Validates TruScreen’s Clinical Edge

TruScreen (NZX/ASX:TRU) has emerged from the world’s largest opto-electronic cervical screening study with a significant clinical endorsement. Published in February 2026 in the German journal BMC Cancer, the study spanned 64 hospitals across nine Chinese provinces and involved nearly 15,000 women. It demonstrated TruScreen’s superior sensitivity (87.5%) compared to Liquid Based Cytology (66.5%) and higher specificity (88.4%) than both Pap tests and HPV testing.

Notably, TruScreen combined with HPV co-testing achieved a sensitivity of 98.4%, edging out the traditional Pap plus HPV method at 95.9%. These findings are poised to prompt the Chinese Society of Colposcopy and Cervical Pathology (CSCCP) to issue an Expert Consensus endorsing TruScreen, potentially accelerating its adoption in national and regional screening programs.

Regulatory Progress and Market Entry in Asia

India, which alongside China accounts for 42% of global cervical cancer cases, is expected to grant regulatory approval to TruScreen within three to six months. The company has already shipped devices and secured distributor appointments, with private hospital consortia evaluating the technology. Meanwhile, TruScreen’s distributor in Vietnam is in advanced talks with the Ho Chi Minh City government to integrate the device into city-wide health check-ups, targeting underserved rural populations lacking laboratory infrastructure.

Further regulatory milestones include Thailand’s FDA approval secured in April 2026 and Malaysia’s approval anticipated in the first half of FY2027. Singapore’s leading gynaecology clinic has also adopted TruScreen as a reference centre for Southeast Asia, supporting the device’s regional credibility.

Expanding Footprint Across Africa and Central Asia

TruScreen is actively preparing for large-scale screening programs in Africa, with a 10,000-woman pilot planned for Zimbabwe in FY2027 following government approval to expand nationwide. The company is also initiating clinical studies in Nigeria and Uzbekistan, with devices and consumables en route to support these efforts. Nigeria, bearing one of the world’s highest cervical cancer burdens, will host a clinical reference centre at the University of Nigeria Teaching Hospital, backed by a Bill & Melinda Gates Foundation grant application.

Central Asian markets such as Kyrgyzstan and Belarus are also on TruScreen’s radar, with product registrations underway and multi-centre clinical studies designed to secure government healthcare adoption. These efforts complement ongoing discussions with distributors in Rwanda, Palestine, and Jordan, while Austrade’s African offices are assisting market entry into Kenya and Tanzania.

Potential Revenue Boost from Global Health Grants

TruScreen has submitted five grant applications to UNITAID, targeting public screening programs across 14 countries in Africa, Asia, and Latin America. If successful, these could add approximately NZ$4 million annually from FY2028 to FY2030. The company is also seeking funding from the Bill & Melinda Gates Foundation and the Clinton Health Access Initiative to support cervical cancer screening initiatives in Africa.

These partnerships with global NGOs and health organizations strengthen TruScreen’s position as a technology provider in low- and middle-income countries striving to meet the World Health Organization’s 90-70-90 cervical cancer elimination targets by 2030.

European Pilot and Clinical Engagements

In Italy, TruScreen is advancing a pilot clinical study with the Italian Association for Cancer Research (AIRC) to compare its technology with existing screening methods. Positive outcomes could lead to installations across 17 AIRC committees, potentially deploying up to 50 devices. Key opinion leaders in Italy are backing this initiative, aiming to establish clinical reference centres to support broader European adoption.