TruScreen Signs MOU with Hangzhou Dalton Bioscience

NZX/ASX Announcement
27 February 2025
TruScreen Signs MOU with Hangzhou Dalton Bioscience
to Expand its HPV Product Offerings
• TruScreen Group Limited has signed a non-binding Memorandum of Understanding
(“MOU”) with Hangzhou Dalton Bioscience Limited (“DaltonBio”), a leading China based
manufacturer of high-performance HPV DNA tests and laboratory equipment for
cervical cancer screening.
• The MOU provides a framework for collaboration to distribute, and marketing of
complementary HPV related In Vitro Diagnostics (“IVD”) products through the selected
TruScreen global distribution network, under the TruScreen brand.
• The MOU supports TruScreen’s strategy to expand its HPV related product portfolio that
strengthens its global position in the women’s health sector.


TruScreen Group Limited (NZX/ASX: TRU),
(“TruScreen” or “the Company”), a global leader in AI-
enabled cervical cancer screening, is pleased to announce that it has signed a non-binding MOU with
DaltonBio , a leading China based manufacturer of high-performance HPV DNA tests and laboratory
equipment for cervical cancer screening, to expand global commercial opportunities for a suite of
DaltonBio’s HPV related IVD products to be marketed under the TruScreen brand.
The collaboration will enhance access to innovative cervical cancer screening and detection solutions
by leveraging the technology strengths of both companies.
Pursuant to the MOU, TruScreen and DaltonBio will negotiate to formalise a distribution agreement within
three months from the date of the MOU. The proposed collaboration consists of two key stages:
1. Short-Te r m Collaboration: TruScreen will conduct due diligence on DaltonBi o’s HPV related IVD
products, namely HPV DNA tests, and self-sampling tests for marketing through TruScreen’s
selected global distribution network.
2. Medium-to-Long-Term Strategic Alliance: Subject to a successful stage 1 collaboration,
TruScreen to be appointed a global distributor of DaltonBio HPV related IVD products (excluding
U.S.A. and Canada). DaltonBio to explore opportunities to assist Tr u S c re e n’s AI enabled real time
cervical screening device within its distribution network, notably in its selected distributors in
China and South America.
TruScreen CEO, Marty Dillon commented: "This collaboration is a significant step forward in our mission
to provide innovative and accessible cervical cancer screening solutions worldwide. Dalton BioSciences
HPV screening tests complement TruScreen’s AI enabled real-time cervical screening technology. This
will enable TruScreen to offer a range of comprehensive solutions to healthcare providers globally. We
are excited about the potential of this partnership and look forward to progressing towards a formal
distribution agreement."

DaltonBio Founder and President, Dr. Ben Hua commented: "Both DaltonBio HPV tests and TruScreen
AI enabled screening worked in conjunction with each other as a triage to confirm the positive result of a
patient, prior to treatment for HPV cancerous lesions. This collaboration is a natural extension of both
companies’ technologies to offer best available solutions to healthcare clinicians globally. Our cost-
effective high-performance HPV DNA tests and other IVD products for women’s health are ideally suited
for use in many countries where TruScreen has distribution. We look forward to progressing towards a
formal distribution agreement for TruScreen."

TruScreen was advised by the Sydney team of Hong Kong headquartered Innokylin Capital Limited .

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 and in 2024 was added to the
Russian guidelines for the screening of cervical cancer.
In financial year 2024 alone, over 200,000* examinations were performed with the 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.

About DaltonBio:

DALTON BioSciences ("DALTONbio®") is a global, innovative medical technology company focusing on
in vitro diagnosis (IVD) in women's health and oncology. DALTONbio® is the leader in human
papillomavirus (HPV) nucleic acid testing and comprehensive cervical cancer detection and screening.
Its high performance HPV DNA detection kits (DH HPV test series) are the world's only products based
on its third-generation proprietary hybrid-capture technology, which provides HPV genotyping without
requiring nucleic acid extractions and amplifications. This technology is well-suited for the detection of
high-risk types of HPV and cervical cancer screening. DALTONbio’s exceptional, clinically proven
products have served tens of millions of lives in the world. They have aided health professionals in
detecting, diagnosing, and treating illnesses earlier and more effectively, resulting in healthier people
everywhere, every day.
To learn more, please visit: www.daltonbio.com/
.

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