Truscreen Test Outperforms Pap Smear in Saudi Arabia Study

NZX/ASX Announcement

5 August 2024
TruScreen Cervical Cancer Screening Test Outperforms
traditional Pap Smear in Saudi Arabia Study
Highlights
• 5
07 women tested from 2021-2022, results p ublished in July 2024
• High Sensitivity and Specificity: TruScreen demonstrated a sensitivity of 83.3% and a
specificity of 95% for detecting cervical lesions (neoplasms), compared to 66.7% and 98.2%
for Pap smear, respectively
1
.
• Real-Time Results: The TruScreen device provides immediate screening results, eliminating
the need for laboratory equipment and pathology staff.
• Practical and Reliable: The study confirmed that TruScreen is a practical and reliable
screening tool, suitable for use in various healthcare settings.

TruScreen Group Limited (NZX/ASX:TRU) is pleased to announce the preliminary publication, on 25 July
2024, of a study titled “Beyond Tradition: Investigating TruScreen’s Performance Versus Pap Smear in
Cervical Cancer Detection” on Research Square
1
Link. The preliminary publication is subject to peer
review.

.



The authors concluded that TruScreen “represents a reliable, practical screening tool for cervical
neoplasms” and that their results “provide an evidence-based approach for policymakers when
selecting the optimal cervical cancer screening strategy in countries without an established national
screening program.”

This study reinforces TruScreen’s commitment to providing innovative and accessible healthcare
solutions. The positive results validate TruScreen’s technology and opens new opportunities in the
global healthcare market.

For more information, please visit our website at www.truscreen.com
.

1.
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]

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
In financial year 2024 alone, over 200,000* examinations have been performed
with 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