Truscreen Group

What Truscreen Group does

Truscreen Group Limited (NZX/ASX: TRU) is a New Zealand-headquartered medical device company that has developed and commercialises the TruScreen device, an AI-enabled opto-electronic system for primary cervical cancer screening. The device uses multi-wavelength optical measurements (four discrete visible and infrared bands) combined with electrical decay curve measurements, analysed by proprietary AI algorithms, to detect precancerous and cancerous cervical changes in real time at the point of care. Unlike competing devices that operate only as triage or adjunct tools, TruScreen is registered in multiple jurisdictions as a standalone primary screening instrument, and the technology is positioned to serve settings without laboratory infrastructure or trained cytologists.

The company monetises through a device-plus-consumable model: it sells the TruScreen hardware to distributors and health facilities and generates recurring revenue from proprietary Single Use Sensors (SUS) used per patient, with peak pull-through reaching 137 SUS per month per device in China. It also distributes DaltonBio HPV DNA IVD kits in India as a complementary co-testing product. As of late 2025, 247 TruScreen devices were operational globally, and the company distributes through regional partners across 20 countries including China, India, Indonesia, Vietnam, Zimbabwe, Uzbekistan, South Africa, Mexico, and parts of Europe and the Middle East. End customers are primarily government public health programmes, national AIDS councils, and private hospitals in low- and middle-income countries, with institutional endorsement from WHO, UNITAID, PATH, and the Clinton Health Access Initiative.

In FY2026, Truscreen reported preliminary unaudited product sales of approximately NZ$2.4 million (up 41% YOY) and total revenue of approximately NZ$2.8 million, with a 31.5% gross margin and a net loss of NZ$2.25 million. Revenue is heavily concentrated in China through the SWXT distributor (61.3% of FY2026 sales), creating significant single-channel exposure alongside broad but still nascent geographic diversification. The company is publicly listed on NZX and ASX, has 11-50 employees, and raised approximately NZ$4 million via an oversubscribed Placement and Rights Issue in June 2026 to fund further geographic expansion.

Name

Truscreen Group

Legal name

Truscreen Group Limited

Website

https://truscreen.com

Company type

Public

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

Truscreen Group (NZX/ASX: TRU) is a New Zealand-listed medical device company that develops and distributes the TruScreen AI-enabled opto-electronic device for real-time, standalone primary cervical cancer screening, selling hardware plus recurring single-use sensors to government health programmes and hospitals across 20 emerging-market countries.

Ownership category

akta.pro rank

Product category

Cervical Cancer Screening Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Surgical & Medical Instruments & Apparatus (3841), Optical Instruments & Lenses (3827)

akta.pro primary industry

Safety/Pharmacovigilance (PV) & Clinical Safety Systems (HLACAOAH)

akta.pro secondary industry

Personal Medical Devices & Home Diagnostics (Thermometers, Blood Pressure Monitors, Glucose Meters, Rapid Tests) (CRADAMAK)

Keywords

• Cervical cancer screening
• Opto-electronic medical device
• AI diagnostic technology
• Gynecological screening
• Single-use medical sensors

Headquarters

HQ city

Auckland

HQ country

New Zealand

HQ region

Oceania

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Technology or R&D, Marketing or Sales, Supply Chain

Revenue model

1. Device sales: Sale of TruScreen AI-enabled cervical cancer screening devices to distributors and healthcare facilities globally.
2. Single Use Sensors (SUS): Recurring consumable revenue from Single Use Sensors (SUS) used with each screening procedure. Consumable sales volume met expectations with pull-through peaking at 137 SUS per month per device in China.
3. HPV test kit distribution: Distribution of DaltonBio HPV-related IVD products in India under the TruScreen brand, expanding product portfolio in key markets.

Pricing tiers

Go-to-market motion2 records

Distribution channels10 records

Marketing channels6 records

Core offering

Truscreen Group develops, manufactures, and sells an AI-enabled medical device (the TruScreen Device) that detects precancerous and cancerous cervical tissue changes in real-time using proprietary optical and electrical measurements. The device is sold with recurring Single Use Sensor (SUS) consumables to healthcare facilities, government health programs, and distributors across 20 countries, primarily in emerging markets where laboratory infrastructure is limited. The company also distributes Dalton Bio HPV test kits in India as a complementary offering.

Product overview

TruScreen Group offers an AI-enabled cervical cancer screening solution comprising the TruScreen Device as the core product and Single Use Sensors (SUS) as consumables. The TruScreen device is a standalone primary screening tool that provides real-time detection of precancerous and cancerous cervical changes using proprietary optical and electrical measurement technology. The company also distributes Dalton Bio HPV Test Kits in India, adding complementary HPV DNA testing capabilities to its product portfolio. Together, these products enable comprehensive cervical cancer screening programs without requiring laboratory infrastructure.

Differentiator

Problem solved

Functional benefit

Products and services

• TruScreen Device An AI-enabled medical device that detects precancerous and cancerous cervical changes in real-time via optical and electrical measurements of cervical tissue. Registered as a standalone primary screening tool (not just triage/adjunct), it provides immediate feedback to patient and operator, enabling same-visit treatment. Requires no laboratory infrastructure or qualified cytologists, making it suitable for remote areas and developing countries.
• Single Use Sensors (SUS) Proprietary single-use sensor consumables used with the TruScreen Device for each patient screening procedure. These consumables generate recurring revenue with usage-based billing, with pull-through peaking at 137 SUS per month per device in China.
• Dalton Bio HPV Test Kits HPV-related In Vitro Diagnostics (IVD) products manufactured by Hangzhou Dalton Bioscience Limited that TruScreen distributes in India under the TruScreen brand. Includes HPV DNA tests and self-sampling tests for cervical cancer screening, complementing TruScreen's AI-enabled primary screening technology. Co-testing with TruScreen and HPV DNA has shown to increase sensitivity to 98.4%.

Quantifiable outcome

• 87.5% sensitivity vs 66.5% for Liquid Based Cytology in COGA study (n=14,982)
• +3 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature5 records

Partnerships

16 partnerships are on record, tiered core and minor.

• Albatros Health Care LLCcoreChannel Partner/ Reseller/ Distributor · 18 May 2026Uzbekistan distributor appointed May 2026. Leading medical device distributor established 2017 with nationwide sales network. Sales revenue potential USD740,000 (NZD1.26m) over 30-month period to end of 2028.
• PT Mawar Mitra MedikacoreChannel Partner/ Reseller/ Distributor · 1 May 2026Indonesia distributor (also referred to as Marwa Mitra Medika). Pilot clinical study underway. Collaborating with Ministry of Health for government public screening programs.
• Xerox Medica LimitedminorChannel Partner/ Reseller/ Distributor · 1 May 2026Bangladesh distributor appointed May 2026 with projected first-year sales revenue of NZD 554,000. Government procurement application submitted June 2026.
• JSC IMScoreChannel Partner/ Reseller/ Distributor · 1 May 2026Central Asia distributor. Multi-centre clinical study in progress for government healthcare provider recognition. Kazakhstan commercial use commencing FY2027. Product registrations submitted in Kyrgyzstan and Belarus.
• Chinni Oy Euro Asia SRLminorChannel Partner/ Reseller/ Distributor · 1 May 2026Italy and Romania distributor authorized February 2026. Product introduction meeting at Borgo Trento Hospital Verona. AIRC Italy engaged for pilot clinical study of 650-800 women.
• Renovate Biologicals Pvt LtdcoreChannel Partner/ Reseller/ Distributor · 1 April 2026India distributor appointed April 2025. Interim Product Testing license obtained July 2025. Regulatory approval application submitted April 2026. Also authorized to investigate Western Europe and Middle East commercial opportunities.
• PATH (Program for Appropriate Technology in Health)coreStrategic or Co-development Partner · 1 April 2026Global technical partner for UNITAID proposals. Provides programme design support, monitoring and evaluation frameworks, and strategic linkages for government ownership of screening services.
• Solina Centre for International Development and Research (SCIDaR)coreImplementation/ SI/ Consulting Partner · 1 April 2026Implementation partner for Nigeria in UNITAID proposals. Nigerian nonprofit with relationships with state and federal health authorities, experience in training frontline health workers at scale.
• RedAid NigeriacoreImplementation/ SI/ Consulting Partner · 1 April 2026Community health delivery and outreach partner for Nigeria in UNITAID proposals. Focuses on bringing essential health services directly to communities furthest from formal healthcare infrastructure.
• Baylor College of Medicine Children's Foundation EswatinicoreImplementation/ SI/ Consulting Partner · 1 April 2026Implementation partner for Eswatini in UNITAID proposals. National leader in pediatric HIV/AIDS care with expanded scope to cancer screening, treatment, and education.
• Lagos State University Teaching Hospital (LASUTH)coreStrategic or Co-development Partner · 1 April 2026Collaboration on Bill & Melinda Gates Foundation grant application for cost-disruptive cervical cancer screening. Leading tertiary referral centre in Nigeria advising on public health policy.
• AIR (Advanced Integrated Resources)coreChannel Partner/ Reseller/ Distributor · 1 November 2025South Africa distributor appointed November 2025. Supported by Evohealth for registration and logistics. Product registration with SAHPRA submitted March 2026.
• Ho Chi Minh City Public Health AssociationcoreStrategic or Co-development Partner · 1 July 2025Partnership between TruScreen, Ho Chi Minh City Public Health Association and distributor Gorton Health Services for 5-year program to screen 260,000 women for cervical cancer in Ho Chi Minh City launched July 2025.
• Hangzhou Dalton Bioscience Limited (DaltonBio)coreStrategic or Co-development Partner · 28 February 2025Non-binding MOU signed February 2025 for collaboration to distribute DaltonBio HPV-related IVD products through TruScreen's global distribution network. Distribution agreement signed May 2025 for India. Co-testing with TruScreen and HPV DNA shown to increase sensitivity to 98.4%.
• National AIDS Council (NAC) ZimbabwecoreStrategic or Co-development Partner · 1 January 2022Country implementation lead for Zimbabwe in UNITAID proposals. NAC has adopted TruScreen as preferred cervical cancer screening technology since 2022. Over 30,000 women screened under partnership.
• World Health Organization (WHO)coreOthersWHO recognition as technology suitable for cervical cancer screening. UNITAID Call for Proposals aligned with WHO 90-70-90 milestones by 2030.

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Regional players

• Niramai Health Analytix: India-based startup offering a non-invasive, AI-enabled breast cancer screening solution for mass population screening. Comparable as a regional AI-enabled women's health screening company targeting emerging markets.

Broad incumbents

• QIAGEN: Global molecular diagnostics leader with the digene HC2 HPV Test and QIAreach HPV assays, the established HPV primary-screening standard. Competes with TruScreen on the screening modality question (HPV DNA vs. opto-electronic).
• Hologic: US-based leader in women's health diagnostics, including the ThinPrep Pap Test and NovaSure, the dominant cytology-based cervical cancer screening franchise. Broader portfolio than TruScreen but directly competes for cervical screening budgets globally.
• BD (Becton Dickinson): Markets the Onclarity HPV Assay and related women's health diagnostics. A broad incumbent supplying molecular and cytology cervical screening workflows to hospital and public health systems.
• Roche Diagnostics: Operates the Cobas HPV Test, widely adopted in primary HPV screening programs. As a global diagnostics incumbent, Roche sets the standard for HPV-based cervical screening that governments are rapidly adopting.
• Cepheid (Danaher): GeneXpert HPV molecular test delivers rapid PCR-based cervical screening at point-of-care, directly competing with TruScreen's POC convenience proposition in resource-limited settings.

Emerging players

• Visby Medical: Develops palm-sized, single-use PCR diagnostic devices for point-of-care infectious disease testing. Comparable as an emerging POC molecular diagnostics company with a similar disposable-device + instrument business model.
• Delphinus Medical Technologies: Developer of the SoftVue 3D whole breast ultrasound tomography system for adjunctive breast cancer screening. Comparable as an emerging oncology-imaging device company entering screening markets with novel non-ionizing technology.
• MobileODT: Israel-based developer of the EVA VisualCheck AI-enabled portable colposcope for cervical cancer screening in low-resource settings. Most direct emerging competitor to TruScreen in the portable/AI-enabled screening category.
• Aspira Women's Health: US-based developer of blood-based diagnostic tests (OVA1, Overa) for ovarian cancer risk assessment. Comparable as a small-cap emerging women's health diagnostics company competing in cancer screening.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UC
• LinkedInlinkedin.com/company/truscreen
• Facebookfacebook.com/TruscreenGroupLtd

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Truscreen Group