Truscreen Opto-electrical Technology Recognised

NZX/ASX Announcement
2 August 2023
TruScreen opto- electrical technology recognized in China Cervical Cancer Screening
Guideline by top national expert organisation

Highlights
• China published the First national medical guideline in the world that recognise s
TruScreen technology
• China Cervical Cancer Screening Guideline (Guideline) of Chinese Society for
Colposcopy and Cervical Pathology (CSCCP) recognises TruScreen technology
in section “Other Cervical Cancer Screening Methods”
• The Guideline recognises TruScreen technology as the only AI enabled method
for cervical cancer screening in China

Truscreen Group Limited (NZX/ASX:TRU) is pleased to advise that the CSCCP’s (Chinese Society
for Colposcopy and Cervical Pathology) China Cervical Cancer Screening Guideline published in the
July edition of CSCCP’s journal recognised TruScreen technology in the Chinese Journal of Clinical
Gynaecology and Obstetrics in July 2023.

The formal publication follows from media announcement at major national congress of CSCCP in
Beijing in May 2023.

CSCCP’s decision to include TruScreen technology in its new Guideline emphasises the role of new
technology in the booming Chinese healthcare sector that focuses on AI and digitalisation of medical
processes and practices. The decision is based on the body of evidence supporting TruScreen clinical
use gathered in China and world-wide. The decision was also made after extensive consultations
with healthcare practitioners and decision makers.

CSCCP is a member of IFCPC (The International Federation of Cervical Pathology and Colposcopy)
which is dedicated to reducing the incidence of cervical cancer worldwide through the focus on basic
and applied research, sharing of knowledge surrounding appropriate fields, and standardization of
terminology in the field of cervical pathology. T he guideline issued by CSCCP is a leading clinical
standard for doctors and other healthcare clinicians and government agencies.

CE
O, Dr Beata Edling commented:
“I am delighted to see TruScreen reaching this important technology acceptance milestone. The
CSCCP recognition of TruScreen’s technology strengthens opportunities for transforming cervical
cancer screening worldwide and will have a positive impact on our sales and marketing in the coming
years.”

This announcement has been approved by the Board.

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

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 financial year 2023 alone, over 140000* 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

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