Germany's Springer Nature Journal Publication on TruScreen

NZX/ASX Announcement

11 November 2024


Report published by leading research journal, Germany’s Springer Nature concluded
that TruScreen cervical cancer screening results were comparable and even better
(for patients with type 3 TZ) than conventional LBC (Liquid based Cytology)

Highlights
• Evaluation of a real-time optoelectronic method for the detection of cervical
intraepithelial neoplasia and cervical cancer in patients with different
transformation zone (TZ) types
• A cohort of 1,908 women aged 34.0±7.3 years who have received cytology (LBC),
human papillomavirus (HPV) testing, TruScreen, and colposcopy were
evaluated
• TruScreen detection accuracy was comparable to liquid-based cytology (LBC
and performs even better in patients with type 3 TZ

TruScreen Group Limited (NZX/ASX: TRU) is pleased to advise the publication of “Evaluation
of a real-time optoelectronic method for the detection of cervical intraepithelial neoplasia and
cervical cancer in patients with different transformation zone types” conducted by Dr Fengyi
Xiao & Professor Long Sui from The Cervical Diseases Centre, Obstetrics and Gynaecology
Hospital of Fudan University, Shanghai, China. The study evaluated the diagnostic value of
TruScreen, a real-time diagnostic technology, for cervical lesions in patients with different
transformation zone (TZ) types.
Full report can be downloaded from the below link.
https://www.nature.com/articles/s41598-024-78773-w
The Obstetrics and Gynaecology Hospital of Fudan University study concluded that
TruScreen optoelectronic real time screening detection accuracy was comparable to
liquid-based cytology (LBC) and outperformed in patients with type 3 TZ.
The publication of the Fudan University’s study results reiterated the COGA (Chinese
Obstetricians and Gynaecologists Association) large scale clinical trial of 15,661 patients
conducted across 9 China Provinces over 3 years, that determined TruScreen to be a simple,
effective and rapid real-time method to screen for cervical cancer. The COGA trial results
highlighted the superiority of TruScreen against alternative screening methods as well as the
potential benefits of a TruScreen-HPV co-testing (see NZX/ASX announcement 05 April
2022 ).
The Fudan University patient cohort have received cytology, human papillomavirus (HPV)
testing, TruScreen, and colposcopy. The clinical performances of these tests were evaluated
for their detection of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in
situ (AIS), or more severe lesions in patients with different TZ types.

The results of the study found:
• TruScreen's sensitivity
1
(65.08%) was higher to that for LBC (57.14%),

• TruScreen’s specificity
2
(64.76%) was similar to that of LBC (64.47%).

For patients with type 3 TZ, TruScreen results outperformed LBC
• TruScreen's sensitivity
3
(72.29%) was higher to that for LBC (65.06%),

• TruScreen’s specificity
4
(67.39%) was higher to that of LBC (64.29%).

Martin Dillon, CEO said: “The Fudan University study by Dr Fengyi Xiao and Professor
Long Sui affirms the TruScreen AI enabled optoelectronic cervical cancer screening
technology. As member nations of the World Health Organisation embrace the WHO’s
objective of eliminating cervical cancer by the end of the century, TruScreen real time
screening technology is a vital medical device to support the global task of achieving
WHO’s strategy.
The TruScreen real time technology does not require expensive pathology infrastructure
and is the screening technology of choice for countries with regional areas with limited
access to pathology laboratory testing infrastructure and qualified clinicians to interpret the
results.” “TruScreen is approved and on the national cervical cancer screening guidelines
of China and Russia, and on the national Technical List of Vietnam’s MoH and Cofepris of
Mexico for use in the public health sector. Several countries are currently evaluating
TruScreen for inclusion into its national screening guidelines”
This announcement was approved for release by the Board.
-ENDS-
For more information, visit www.truscreen.com or contact:
Marty Dillion
Chief Executive Officer
martindillon@truscreen.com
Guy Robertson
Chief Financial Officer
guyrobertson@truscreen.com


1
Sensitivity measures correctly a positive result for patients who have the condition that is being tested for (also known as the “true
positive” rate). A test that is highly sensitive will indicate patients who have the disease.
2
Specificity measures correctly a negative result for people who do not have the condition that is being tested for (also known as the “
true negative” rate). A high-specificity test will correctly rule out patients who do not have the disease.
3
Sensitivity measures correctly a positive result for patients who have the condition that is being tested for (also known as the “true
positive” rate). A test that is highly sensitive will indicate patients who have the disease.
4
Specificity measures correctly a negative result for people who do not have the condition that is being tested for (also known as the “
true negative” rate). A high-specificity test will correctly rule out patients who do not have the disease.

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 23 countries. In 2021, TruScreen established a manufacturing facility in
China for devices marketed and sold in China, with the “Made in China” registration.
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, by COGA (Chinese
Obstetricians and Gynaecologists Association).
In financial year 2023 alone, over 140000
1
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/.
1
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