Outstanding Clinical Evaluation Results from Saudi Arabia

NZX/ASX Announcement

14 March 2023

Outstanding Clinical Evaluation Results from Saudi Arabia

Highlights

• First clinical evaluation completed in the Middle East
• Results show sensitivity and specificity better than or close to Liquid Based
Cytology testing

Truscreen Group Limited (NZX/ASX:TRU) is pleased to advise that the leading private medical
services provider , Dr. Sulaiman Al-Habib Medical Group (DSAMG), has recently completed the
analysis of results from its cervical screening clinical evaluation of TruScreen Ultra and Liquid Based
Cytology (LBC).

A cohort of 507 women were examined with TruScreen and LBC across multiple medical centres of
DSAMG. The preliminary results confirmed that TruScreen’s sensitivity was 83.3% (LBC: 66%) and
specificity was 95% (LBC 98%).

Lead investigator Dr. Majed Alhudhud, Head of OBGYN Department at Arryan Hospital, said
“There is no national program for cervical cancer screening in Saudi Arabia, and we see TruScreen
as a strong alternative to the standard LBC. In the study we found TruScreen to be as effective as
LBC, while also providing real time results and resolving many of the issues faced with potential
patient follow-up when using LBC.”

TruScreen’s CEO, Dr Beata Edling commented, “We are delighted with the results of our first clinical
evaluation in Saudi Arabia and the Middle East. It validated clinical evaluations conducted in China.
Australia, and Vietnam. We looked forward to enhanced women’s health care in Saudi Arabia and to
the neighbouring Gulf countries. TruScreen is represented in this region, by our distributor, BettaLife
Group”.


This announcement has been approved by the Board.
Ends


For more information, visit www.truscreen.com or contact:

Dr Beata Edling
Chief Executive Officer
beataedling@truscreen.com

Guy Robertson
Chief Financial Officer
guyrobertson@truscreen.com

Julia Maguire
Investor Relations
julia@thecapitalnetwork.com.au

About TruScreen:

TruScreen Group Limited (NZX/ASX: TRU) is a New Zealand-based medical device company that
has developed an AI-enabled device that can detect precancerous and cancerous cervical changes
in real-time via optical and electrical measurements of cervical tissue. Unlike many cervical screening
technologies that have only triage/adjunct functionality, the TruScreen device is registered as a
primary screening tool.
TruScreen’s cervical screening technology effectively resolves many of the ongoing issues with
conventional cytology, including failed samples, poor patient follow-up, patient discomfort, and the
need for supporting laboratory infrastructure.
The device is CE-marked, meaning it meets EU safety, health and environmental protection standards
required for sale and use throughout Europe. It is also National Medical Products Administration
approved for sale in China. In 2021, TruScreen established a manufacturing facility in China for
devices marketed and sold in China.
TruScreen is currently targeting product sales to a range of low and middle-income countries,
including China, Mexico, Vietnam, Russia, Zimbabwe and Saudi Arabia, where no large-scale cervical
cancer screening programmes and infrastructure are currently in place. By doing so, the Company
hopes to help improve the health and wellbeing of women worldwide.
To learn more, please visit: www.truscreen.com/