TRU - Key Markets Update

Monday 16th June 2025

• On track - Uzbekistan regulatory approval for TruScreen enables commencement of validation as prelude to a planned major screening program

• On track - Zimbabwe validation to commence on 7 July and completed by 21 July, a precursor to recommencement of major public screening program

• On track - Ho Chi Minh City screening program to commence 28 July, with staff training completed and devices shipment underway

• On track - First commercial sales in India with purchase order from Renovate Biologicals

• Dovepress publishes Beijing study confirming TruScreen’s superiority to other screening methods

TruScreen Group Limited (NZX/ASX: TRU), (“TruScreen” or “the Company”), a global leader in AI-enabled cervical cancer screening, is pleased to provide an update of its key and target markets.

Uzbekistan regulatory approval received

TruScreen has received regulatory approval by the National Pharmaceutical Safety Committee in Uzbekistan. Product registration will enable commencement of a short validation program in Tashkent. This validation is a precursor to the planned public screening program starting with 14 women and children’s healthcare clinics in Tashkent. The adoption of TruScreen’s unique AI enabled technology is a transformative step for Uzbekistan, with the aim of extending from Tashkent to a national program.

Uzbekistan has over 11 million women of screening age* and is also a regional healthcare reference site for neighbouring Central Asian nations.

Zimbabwe validation to be completed 21 July

Since 2022, TruScreen has screened 14,000 women in the Masvingo Province, Zimbabwe, through a public screening program managed by the Zimbabwe National AIDS Council (NAC) and the Ministry of Health and Childcare. To recommence and expand the program to the capital Harare and other provinces, a re-validation program is being undertaken by the Ministry of Health. The validation, will commence on 7 July and completed by 21 July 2025.

With limited pathology services and no nationwide recall system for follow-up treatments, traditional screening methods such as pap tests are not suitable for Zimbabwe’s population. TruScreen, which enables a ‘see and treat’ screening service, is ideally suited to fill the gap in Zimbabwe’s women healthcare system.

Ho Chi Minh City screening program commencing 28 July

In April 2025, a 5-year program to screen 260,000 women for cervical cancer using TruScreen in Ho Chi Minh City, Vietnam, was launched to assist the Government of Vietnam to achieve its goal of screening 60% of women aged 30 to 54 for cervical cancer (currently only 25% screened).

Initial training of screening staff is completed, and six TruScreen devices have been shipped to Vietnam for the start of the program which commence on 28 July 2025.

First TruScreen order from India landed

TruScreen advises that its distributor Renovate Biologicals Pvt Ltd (RBL) has placed it’s first order for 10 devices and 1,080 Single Use Sensors.

India has the world’s second largest screening population of over 460 million women*. Cervical cancer is the second most common cancer among women in India, but screening rates are only 2%. India’s National Academy of Medical Sciences (NAMS) has recently recommended a target to achieve a 70% screening rate for cervical cancer by 2030.

TruScreen’s Superiority Confirmed in Beijing Study

The results of a study conducted at Beijing Obstetrics and Gynecology Hospital, China, in July 2018 which analysed the diagnostic efficacy of different testing methods, alone and in combination, for cervical precancerous lesions has now been formally peer reviewed and published by Dovepress.

The study, entitled “Assessment of the Real-Time Photoelectric Detection Device (TruScreen) in Screening for Cervical Precancerous Lesions in Middle-Aged Women: An Observational Study”1, confirms TruScreen’s superiority as a standalone cervical cancer screening method, and highlights it’s power to boost efficacy of results when used in combination with other testing methods such as ThinPrep cytologic tests (TCT) and HPV tests – “effectively avoiding missed diagnoses, which is particularly important in the diagnosis and treatment of precancerous lesions.”

TruScreen demonstrated:

• the highest sensitivity (86.4%) and highest specificity (74.4%) for detecting CIN II or higher lesions, superior to those of liquid based cytology (TCT/LBC or the pap smear) alone (sensitivity, 81.8%; specificity, 38.2%) and HPV testing alone (sensitivity, 81.8%; specificity, 28.2%).

• the highest Negative Predictive Value (NPV ) of 95.1 so it can be concluded that TruScreen has the best ability to exclude non at risk patients. Negative Predictive Value is the probability that a patient does not have the disease.

• the highest Youden index (0.608), indicating that this screening method had the best effect and the greatest authenticity. Youden index is a measurement of diagnostic test effectiveness.

Highlighting that TruScreen has low sampling technology requirements for clinicians, does not require laboratory doctors or pathologists equipped with PCR equipment to verify and requires minimal training for operators, the authors to concluded that TruScreen is particularly suitable “in settings with limited medical resources or under special circumstances when access to healthcare is restricted.”

TruScreen CEO, Marty Dillon commented: "These milestone achievements are part of the fulfilment of TruScreen’s plans announced with its preliminary results in May 2025 and reinforce TruScreen’s strategy is on track to grow distribution capability in emerging markets, including three of the four most populous countries in the world – China, India and Indonesia.”

This announcement has been approved by the Board.

Ends

TruScreen Key Markets Update

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