TruScreen Eyes India and UNITAID Deals After 42% Sales Jump in FY2026
TruScreen posts 42% sales growth in FY2026 as global footprint widens
In its May 2026 investor presentation, TruScreen Group Limited (ASX: TRU) reported FY2026 unaudited sales of NZD $2.4 million, representing 42% year-on-year growth from NZD $1.7 million in FY2025, with total revenue rising 33% to NZD $2.8 million. The presentation also outlined a strategic FY2027 roadmap anchored by regulatory milestones across India, South Africa and Indonesia, alongside pending UNITAID funding decisions that could materially accelerate the company’s revenue trajectory.
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FY2026 by the numbers — a year of recovery and acceleration
The FY2026 results reflected both a recovery in financial position and a broadening of the company’s commercial base, with cash rebounding significantly and net assets more than doubling year-on-year.
Key financial results at a glance
| Metric (NZD millions) | FY24 Actual | FY25 Actual | FY26 Actual (unaudited) | YOY Change (FY25→FY26) |
|---|---|---|---|---|
| Sales | $2.1m | $1.7m | $2.4m | +42% |
| Total Revenue | $2.6m | $2.1m | $2.8m | +33% |
| COGS | $1.4m | $1.2m | $1.7m | +42% |
| EBITDA | -$2.0m | -$2.2m | -$2.2m | No change |
| Net Assets | $3.2m | $1.0m | $2.6m | +160% |
| Cash | $2.7m | $0.04m | $1.5m | Significant recovery |
While EBITDA remained unchanged at -NZD $2.2 million, the strong sales trajectory and cash recovery from near-zero levels (NZD $0.04 million to NZD $1.5 million) signal improved operational sustainability. China SUS/Device Pull Through declined 4% year-on-year, reflecting challenging economic conditions in the company’s anchor market.
Geographic diversification — a structural shift
One of the most significant developments in FY2026 was the deliberate reduction in revenue concentration. In FY2025, China represented 87.6% of total sales. By FY2026, that figure had dropped to 61.3%, with new markets generating meaningful contributions across multiple regions:
- Zimbabwe: 22.4%
- Central Asia: 6.2%
- Vietnam: 5.1%
- Mexico: 2.6%
- India: 1.6%
- Indonesia: 0.8%
The presentation framed this shift as intentional strategic diversification, with new markets now delivering real revenue rather than remaining at pilot stage.
Five marquee wins that define FY2026
Management spotlighted five highlights from the year that illustrate both the breadth of TruScreen’s commercial progress and the scale of addressable opportunities ahead.
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Vietnam 260,000-woman programme. A 5-year cervical cancer screening programme was launched in Ho Chi Minh City in partnership with HPHA and Gorton Health Services. Planned national expansion targets a market of approximately 35 million women of screening age.
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India re-entry. Renovate Biologicals Pvt Ltd was appointed as distributor in April 2025, with an interim testing licence obtained in July 2025 and 10 devices shipped. A full regulatory submission was filed in April 2026, with approval expected within 3 to 6 months. India represents a market of 468 million women of screening age.
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BMC Cancer landmark study. Published in February 2026, the study covered 14,982 women across 64 hospitals and 9 provinces, recording CIN2+ sensitivity of 87% and CIN3+ sensitivity of 90%. The presentation described it as the largest opto-electronic cervical screening study ever published.
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UNITAID — three proposals submitted. Three funding proposals were submitted covering 14 high-burden countries, with an addressable market of 1 billion women and potential revenue of up to US$18.4 million to TruScreen as consortium lead.
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Distributor footprint expanded. New distributors were signed in South Africa, Uzbekistan, Bangladesh, Romania and Italy, with further signings pending in Nigeria, Rwanda and Palestine.
BMC Cancer (2026) — Study Authors
“TruScreen has the highest AUC for both CIN2+ and CIN3+, indicating it was the most accurate test overall.”
What TruScreen does — and why LMICs are the right market
TruScreen is an AI-enabled, real-time cervical cancer screening device designed to deliver accurate results at the point of care, without the need for laboratory infrastructure. For every patient screened, a new disposable Single Use Sensor (SUS) must be used, creating a recurring consumable revenue stream alongside device sales.
The company manufactures two devices: one in China, for use in China where locally manufactured products receive preferential market access, and one in Australia for all other markets. TruScreen’s strategy deliberately targets Low and Middle Income Countries (LMICs), markets that have little or no existing large-scale cervical cancer screening infrastructure. This absence of competing systems creates a gap that TruScreen’s capital-light model can fill without requiring laboratory buildout.
The WHO 90-70-90 cervical cancer elimination target, with a deadline of December 2030, was cited in the presentation as a “game changer” that is creating a tangible sense of urgency for governments and NGOs to act.
Key regulatory recognitions include:
- WHO, UNITAID, CE Mark (EU)
- NMPA (China), TGA (Australia), MHRA (UK)
- Approvals in Russia, Mexico, Zimbabwe, Indonesia, Vietnam, Singapore and Thailand
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FY2027 outlook — catalysts on the horizon
Regulatory and commercial catalysts expected in H2 CY2026
The presentation outlined a watchlist of near-term milestones that management expects to drive FY2027 performance:
- India: Full regulatory approval anticipated within 3 to 6 months of the April 2026 filing; a consortium of private hospitals is lined up subject to approval.
- South Africa: SAHPRA approval expected July 2026, with a pilot clinical study to follow on receipt of regulatory clearance.
- Indonesia: Pilot study results to be presented at the POGI Annual Scientific Meeting in July 2026, alongside a product launch symposium sponsored by TruScreen and its distributor.
- Uzbekistan: Pilot clinical study commencing June 2026 under Albatros Health Care LLC, with NZD $1.26 million in 30-month revenue potential through CY2028.
- UNITAID: Funding decisions on all three proposals are expected through CY2026.
- Bangladesh: Government procurement application to be submitted June 2026, with NZD $554,000 projected in first-year sales under Xerox Medica Limited.
- Mexico: Now entering the laboratory system, with FY2027 sales expected to commence.
Gross margin expansion and DaltonBio alliance
Management indicated that an improving country mix is expected to lift gross margin above FY2026’s 31.5% in FY2027, as higher-margin markets outside China contribute a larger share of revenue.
The DaltonBio strategic alliance, formalised via a distribution agreement in Q1 FY2026, adds a complementary product layer to TruScreen’s core device and SUS model. Under the arrangement, TruScreen was appointed as global distributor of DaltonBio HPV-related IVD products, excluding the USA and Canada. DaltonBio’s network of 200 sub-distributors in China may also augment TruScreen’s existing distribution reach in its largest market, presenting a portfolio expansion opportunity that management highlighted as aligned with the company’s broader women’s health strategy.
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