Study Validates Truscreen Safety for Pregnant Women

NZX/ASX Announcement

12 January 2026


Clinical study validates TruScreen’s efficacy and safety for
pregnant women


• Leading Chinese medical publication Family Doctor confirms TruScreen’s efficacy as a
cervical cancer screening tool for pregnant women, in a 2,000-patient study conducted at
Guilin People’s Hospital
• This is the first clinical validation of TruScreen Ultra’s use in pregnancy
• The Study confirms the use to include the screening of pregnant women
• TruScreen’s AI-enabled, real-time, non-invasive device was determined to be a superior
choice for pregnant women compared to TCT (ThinPrep Cytologic Test) due to:
o better tolerance
o lower rates of post-procedure bleeding
o avoidance of sampling-related limitations


TruScreen Group Limited (“TruScreen” or “the Company”) advises that a new study has been published in the
leading Chinese medical publication Family Doctor, validating TruScreen’s efficacy as an initial screening tool for
cervical lesions during pregnancy. This is the first study to focus on TruScreen’s use in pregnancy. The study can
be viewed at https://www.cnki-acc.net/wenzhang/37126.html (in Chinese).

In pregnancy, the cervix is fragile, increasing discomfort and bleeding risk and negatively affecting compliance
and specimen quality during cervical cancer screening. The study retrospectively analyzed 2,000 pregnant women
screened with TruScreen and 900 screened with TCT (ThinPrep Cytologic Test) at Guilin People’s Hospital
between January 2022 and December 2024. It compared baseline characteristics, discomfort during screening,
post screening vaginal bleeding, and pathology from colposcopy directed biopsy.

The study concluded that TruScreen has a high clinical value in screening pregnant women, with diagnostic
performance overall similar to TCT but better tolerance and lower rates of post-procedure bleeding. The authors
note that pregnancy-related cervical changes can impair cytology quality and increase the risk of bleeding,
whereas TruScreen evaluates tissue characteristics non-invasively and avoids sampling-related limitations. They
conclude that TruScreen improves safety, reduces anxiety and unnecessary interventions related to bleeding, and
enhances follow-up compliance.

The comparison between TruScreen and the Thin Prep liquid-based cytology was:

Sensitivity Specificity
TruScreen 73.7% 94.8%
TCT 71.4% 95.2%

The paper concludes that TruScreen is simple to operate, safe, well-tolerated, and provides immediate results,
making it a valuable supplementary and initial screening method for cervical lesions during pregnancy with
good prospects for wider clinical application.

The Family Doctor is a leading print publication in China which supports China's major health policy to establish
a strong primary care system.

TruScreen CEO, Mart in Dillon commented:

“ We are delighted to see the clinical evidence for TruScreen’s use for pregnant women presented so powerfully
and its potential superiority as a screening choice. China is our largest market, with an estimated screening
population of 467 million women*, so it is highly encouraging to see TruScreen’s efficacy reported by a widely
circulated journal in the consumer channels in addition to our many academic clinical performance validations
already conducted there and globally. ”



This announcement has been approved by the Board.


* CIA World Factbook (female population aged 15-64yrs)



Ends





For more informatio n, vis it www.truscreen.com or contact:
Martin Dill on

Chief Execut ive Officer

martindillon@truscreen.com


Guy Robertson

Chie f Fin ancial Officer

guyrobertson@truscreen.com

About TruScreen:


TruScreen Group Li mit ed (NZX/ ASX: TRU) is a medical devic e company that has developed and
manufactures an AI-enabled device for detecting abnormalities in the cervical tis sue in real-t ime via
measurements of the lo w level of optical and electrical stimuli.

TruScreen’s cervical screening technology enables cervical screening, negatin g sampling and processing of
biological tissues, failed samples, missed follo w-u p, disc omfort, and the need for costly, specialised
pers onnel
and supportin g laboratory infrastructure.
The TruScreen devic e, TruScreen Ultra
®
, is registered as a primary screening devic e for cervical cancer
screening.

The device is CE Marked/EC cert ified, ISO 13485 compli ant and is registered for clinical use with the TGA
(Australia), MHRA (UK), NMPA (China), SFDA (Saudi Arabia), Roszdravnadzor (Russia), and COFEPRIS
(Mexic o). It has Min is try of Health approval for use in Vietnam, Israel, Ukraine, and the Philippines, among
others and has distributors in 29 countries. In 2021, TruScreen establi shed a manufacturing facili ty in
China for devices marketed and sold in China.

TruScreen technology has been recognised in CSCCP’s (Chinese Socie ty for Colposcopy and Cervical
Pathology)
China Cervical Cancer Screening Management Guideline.

TruScreen has been recognis ed in a China Blu e Paper “Cervical Cancer Three Stage Standardized Prevent
and Treatment” published on 28 April 2023.

In Dec 2023 TruScreen technol ogy was added to the Vie tnam Minis try 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 cerv ical cancer.

In financial year 2024 alone, over 200,000* examinations were performed with the TruScreen device. To
date, over 200 devices have been installe d and used in China, Vietnam, Mexico, Zimbabwe, Russia, and
Saudi Arabia. TruScreen’s visio n is “A world without the cervical cancer”
©
.

To learn more, ple ase vis it : www
.truscreen.com/.

*Based on Single Use Sensor sales.

Glossary:
Pap
smear (the Papanicola ou smear) test involv es gatherin g a sample of cells from the cervix, wit h a
special brush. The sample is placed on a gla ss sli de or in a bottle containing a solutio n to preserve the
cells. Then it is sent to a laboratory for a pathologist to examin e under a
microscope. https://www.cancer.net/navigating-cancer-care/diagnosing-cancer/tests-
andprocedures/pap-test

LBC (the liquid-based cytology) test, transfers a thin la yer of cells, collected wit h a brush from the
cervix , onto a sli de after removin g blo od 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 testin g may be done by itself or combined wit h 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 mathemat ically describe the accuracy of a test whic h reports the presence or
absence of a condition. If individuals who have the condit ion are considered "positiv e" and those who don't
are
considered "negativ e", then sensit ivit y is a measure of how well a test can id entif y true positives and
specificity is a measure of how well a test can identif y true negatives:

• Sensiti vit y (true posit iv e rate) is the probability of a posit ive test result, conditioned on the individual
truly being positive.
• Specificity (true negativ e rate) is the probabilit y of a negativ e test result, conditioned on the individual
truly being negativ e (Sensit ivity and
specificity – Wikipedia).

For mor e informatio n about the cervical cancer and cervical cancer screening in New Zealand and
Australia, ple ase see useful links:

New
Zealand: National Cervical Screening Programme | National Screening Unit (nsu.govt.nz)

Australia: Cervic al cancer | Causes, Symptoms & Treatments | Cancer Council