TruScreen Accelerates Global Expansion with 42% Sales Growth and UNITAID Proposals

Strong Sales Growth Amid Geographic Diversification

TruScreen Group Limited (NZX/ASX:TRU) posted a 42% jump in product sales for the financial year ended March 2026, reaching NZ$2.4 million. This growth was fuelled by expanded distribution and first-time sales in populous markets such as India and Indonesia, which together represent over 560 million women of screening age. China remained the anchor market, accounting for 61.3% of total sales despite economic headwinds. The company’s recurring revenue model, driven by disposable Single Use Sensor sales, continues to underpin its commercial strategy.

The company’s gross margin improved modestly to 31.5% in FY2026, with expectations for further margin gains in FY2027 as revenue broadens across new countries. However, the bottom line remained under pressure, with a loss of NZ$2.25 million reflecting increased marketing and support costs to fuel distributor expansion and public screening program participation.

TruScreen’s recent capital raise of approximately NZ$4 million has bolstered its balance sheet, enabling further geographic reach and investment in growth initiatives. This follows a series of financing activities including a NZ$1.82 million oversubscribed placement in May 2026, which was part of a larger capital raising effort to support global expansion and regulatory compliance NZ$1.82m placement.

New Market Penetration and Public Health Initiatives

TruScreen launched a five-year cervical cancer screening program targeting 260,000 women in Ho Chi Minh City, Vietnam, with plans for national expansion in a market of 35 million women of screening age. The device has been adopted by four leading public hospitals and is gaining traction in the private sector, with multiple clinics awaiting government approvals.

In Indonesia, a pilot clinical study is underway with results expected to be presented at the Indonesian Obstetrics and Gynaecology Association’s annual meeting in July 2026. The company and its distributor Marwa Mitra Medika are sponsoring the conference and aiming to integrate TruScreen into government-funded public screening programs.

India marks a significant re-entry for TruScreen, with Renovate Biologicals appointed as distributor. The company secured an interim product testing license in July 2025 and has shipped devices for clinical and training purposes. Full regulatory approval is expected within 3 to 6 months following the April 2026 submission, paving the way for adoption by a consortium of private hospitals India regulatory approval.

Clinical Validation and UNITAID Funding Proposals

TruScreen’s technology continues to gain clinical validation. Landmark studies published in the German journal BMC Cancer and other peer-reviewed outlets confirm the device’s superior sensitivity and specificity as a primary cervical cancer screening tool. Notably, the largest-ever opto-electronic cervical screening study involving nearly 15,000 women across 64 hospitals demonstrated 87% sensitivity for CIN2+ lesions and 90% for CIN3+ lesions, with the highest overall accuracy among tested methods.

The company has submitted three proposals to UNITAID’s Global Cervical Cancer Elimination Call to Action, targeting 14 high-burden countries across Africa, Asia-Pacific, and Latin America. These proposals represent an addressable market of approximately 1 billion women and could generate up to US$18.4 million in revenue for TruScreen as consortium lead. The device’s AI-enabled, point-of-care design is tailored for low-resource settings lacking laboratory infrastructure, aligning with WHO’s 90-70-90 elimination goals.

Distributor Network Expansion and Regulatory Progress

TruScreen expanded its global footprint with new distributors appointed in South Africa, Uzbekistan, Bangladesh, Romania, and Italy, and pending appointments in Nigeria, Rwanda, Sri Lanka, and Palestine. The company is actively pursuing regulatory approvals in key markets including South Africa (SAHPRA approval expected July 2026), Malaysia, and Central Asian countries such as Kazakhstan, Kyrgyzstan, and Belarus.

In Africa, Zimbabwe’s Ministry of Health approved TruScreen as a primary screening test nationwide following a successful re-validation study, with plans to screen 20,000 women in calendar 2026. In Nigeria, TruScreen is collaborating with Lagos State University Teaching Hospital and the Bill & Melinda Gates Foundation on a grant application, aiming to establish the first African clinical reference centre.

The company’s strategic alliance with Dalton BioSciences complements its cervical screening offering with HPV DNA testing products, enhancing co-testing capabilities and expanding access in markets such as India and China. Dalton Bio’s extensive distribution network in China, comprising 200 sub-distributors, may augment TruScreen’s reach in its largest market Dalton Bio HPV products.

Corporate Developments and Leadership

Corporate governance changes included the retirement of director Juliet Hull and the appointment of Christine Pears, bringing over 20 years of board experience. CEO Martin Dillon is set to rejoin the company on 1 June 2026, expected to spearhead TruScreen’s transformational growth phase. Director Chris Horn will retire after 13 years, with the company seeking an Australian-based non-executive director to join the board.

Despite the encouraging sales growth and expanded footprint, TruScreen continues to operate at a loss, with FY2026 loss stable at NZ$2.25 million. The company’s cash position improved to NZ$1.46 million at year-end, supported by recent capital raises. However, the directors acknowledge material uncertainty regarding going concern, contingent on achieving forecasted revenue growth and cost management.