TruScreen Appoints Distributor to South Africa

NZX/ASX Announcement
4 November 2025
TruScreen appoints distributor to South Africa
• TruScreen appoints Johannesburg distributor AIR to distribute its AI enabled TruScreen
cervical cancer screening system in South Africa
• South Africa has an extremely high cervical cancer mortality rate - 19.6 per 100,000,
compared to New Zealand and Australia’s 1.7 per 100,000
1
, with an estimated 10,702 new
cases of cervical cancer each year and 5,807 deaths annually
1

• South Africa had the 10
th
highest global cervical cancer incidence in 2022
2

• South Africa has an estimated screening population of over 19 million women
4

TruScreen Group Limited (“TruScreen” or “the Company”) advises the appointment of South African
medical products company AIR to distribute its unique AI enabled TruScreen cervical cancer screening
system.
South Africa has an extremely high cervical cancer mortality rate - 19.6 per 100,000, compared to New
Zealand and Australia’s 1.7 per 100,000
1
, with an estimated 10,702 new cases of cervical cancer each
year and 5,807 deaths annually
1
. South Africa had the 10th highest global cervical cancer incidence in
2022
2
.
These statistics highlight persisting challenges South Africa faces with late diagnosis, limited screening
coverage, and healthcare access. TruScreen, is a portable AI enabled, real-time, laboratory-free cervical
cancer screening system that is ideally suited to meet these challenges.
The investigators of TruScreen’s most recently peer-reviewed study in Saudi Arabia concluded:
“TruScreen represents a reliable, practical screening tool for cervical neoplasms and provides an
evidence-based approach for policymakers when selecting the optimal cervical cancer screening
strategy in countries without an established national screening program.
3

AIR will market and sell TruScreen in South Africa and will be supported by Evohealth, a Guateng-based
manufacturer of pharmaceuticals and distributor of pharmacy products and medical devices. They will
register and provide logistics support for TruScreen in South Africa.
Registration is expected to be completed in 3 months, with first sales expected to occur in January 2026.
South African distribution is a key market for TruScreen’s African strategy. TruScreen has major public
screening programs to recommence in Zimbabwe, a proposed local Public Screening program (in
planning) for Eswatini, and early commercial sales in Rwanda. The addition of 19 million women in South
Africa
4
will grow TruScreen’s African distribution reach to an addressable market of 30 million women.

1
ICO/IARC HPV Information Centre (*ICO = Catalan Institute of Oncology and IARC = International Agency for Research on
Cancer)

2
World Cancer Research Fund Cervical Cancer Statistics
3
Majed Alhudhud, Shazia Maqsood, Maab El Hussein et al. Beyond Tradition: Investigating TruScreen's Performance Versus
Pap Smear in Cervical Cancer Detection, 25 July 2024, PREPRINT (Version 1) available at Research Square
[https://doi.org/10.21203/rs.3.rs-4638793/v1]

4
CIA World Factbook women aged 15-64

TruScreen CEO, Martin Dillon commented:
“Adding South Africa is a major milestone in our African distribution strategy. The majority of African
nations are emerging economies with limited or no screening laboratory infrastructure. The TruScreen
technology will assist to reduce deaths from cervical cancer. TruScreen is also well suited to increase
the screening rates in 47 WHO member nations looking to achieve 70% screening rates by 2030.”


This announcement has been approved by the Board.


Ends


For more information, visit www.truscreen.com or contact:
Martin Dillon
Chief Executive Officer
martindillon@truscreen.com
Guy Robertson
Chief Financial Officer
guyrobertson@truscreen.com

About TruScreen:

TruScreen Group Limited (NZX/ASX: TRU) is a medical device company that has developed and
manufactures an AI-enabled device for detecting abnormalities in the cervical tissue in real-time via
measurements of the low level of optical and electrical stimuli.
TruScreen’s cervical screening technology enables cervical screening, negating sampling and
processing of biological tissues, failed samples, missed follow-up, discomfort, and the need for costly,
specialised personnel and supporting laboratory infrastructure.
The TruScreen device, TruScreen Ultra
®
, is registered as a primary screening device for cervical cancer
screening.
The device is CE Marked/EC certified, ISO 13485 compliant and is registered for clinical use with the TGA
(Australia), MHRA (UK), NMPA (China), SFDA (Saudi Arabia), Roszdravnadzor (Russia), and COFEPRIS
(Mexico). It has Ministry of Health approval for use in Vietnam, Israel, Ukraine, and the Philippines,
among others and has distributors in 29 countries. In 2021, TruScreen established a manufacturing
facility in China for devices marketed and sold in China.
TruScreen technology has been recognised in CSCCP’s (Chinese Society for Colposcopy and Cervical
Pathology) China Cervical Cancer Screening Management Guideline.
TruScreen has been recognised in a China Blue Paper “Cervical Cancer Three Stage Standardized
Prevent and Treatment” published on 28 April 2023.
In Dec 2023 TruScreen technology was added to the Vietnam Ministry of Health approved National
Technical List, for use in Vietnam’s public and private healthcare sectors and in 2024 was added to the
Russian guidelines for the screening of cervical cancer.
In financial year 2024 alone, over 200,000* examinations were performed with the TruScreen device. To
date, over 200 devices have been installed and used in China, Vietnam, Mexico, Zimbabwe, Russia, and
Saudi Arabia. TruScreen’s vision is “A world without the cervical cancer”
©
.
To learn more, please visit: www.truscreen.com/.
*Based on Single Use Sensor sales.

Glossary:
Pap smear (the Papanicolaou smear) test involves gathering a sample of cells from the cervix, with a
special brush. The sample is placed on a glass slide or in a bottle containing a solution to preserve the
cells. Then it is sent to a laboratory for a pathologist to examine under a
microscope. https://www.cancer.net/navigating-cancer-care/diagnosing-cancer/tests-and-
procedures/pap-test
LBC (the liquid-based cytology) test, transfers a thin layer of cells, collected with a brush from the cervix,
onto a slide after removing blood or mucus from the sample. The sample is preserved so other tests can
be done at the same time, such as the human papillomavirus (HPV)
test https://www.cancer.net/cancer-types/cervical-cancer/diagnosis

HPV (human papilloma virus) test is done on a sample of cells removed from the cervix, the same
sample used for the Pap test or LBC. This sample is tested for the strains of HPV most commonly linked
to cervical cancer. HPV testing may be done by itself or combined with a Pap test and/or LBC. This test
may also be done on a sample of cells which a person can collect on their own.
https://www.cancer.net/cancer-types/cervical-cancer/screening-and-prevention

Sensitivity and specificity mathematically describe the accuracy of a test which reports the presence
or absence of a condition. If individuals who have the condition are considered "positive" and those who
don't are considered "negative", then sensitivity is a measure of how well a test can identify true positives
and specificity is a measure of how well a test can identify true negatives:
• Sensitivity (true positive rate) is the probability of a positive test result, conditioned on the
individual truly being positive.
• Specificity (true negative rate) is the probability of a negative test result, conditioned on the
individual truly being negative (Sensitivity and specificity – Wikipedia).
For more information about the cervical cancer and cervical cancer screening in New Zealand and
Australia, please see useful links:
New Zealand: National Cervical Screening Programme | National Screening Unit (nsu.govt.nz)
Australia: Cervical cancer | Causes, Symptoms & Treatments | Cancer Council