Sichuan Province Trial Confirms Truscreen Technology

NZX Announcement
19 October 2020

SICHUAN PROVINCE TRIAL CONFIRMS TRUSCREEN TECHNOLOGY
HIGHLIGHTS
• Second phase of national clinical trial in Sichuan Province reported
outstanding results
• Conducted by China Obstetrics and Gynaecology Association (COGA) a
peak gynaecology body in China.
• Trial conducted across 14 hospitals with 1,243 patients participating
• Both sensitivity and specificity targeting pre-cancerous and cancerous
cervical cells performed in aggregate better than other screening methods
(see below table)
Truscreen Group Limited (NZX:TRU) (Truscreen or Company) is pleased to advise results from The
China Obstetrics and Gynaecology Association (COGA) ongoing national clinical trial that will screen over
20,000 women in 100 top-tier public hospitals across 10 provinces in China. The COGA evaluation
compares the TruScreen technology to Liquid Based Cytology (LBC), and HPV DNA testing (HPV) and
targets a nationwide consensus on Truscreen technology application in China as the main outcome of this
large-scale trial.
The outstanding initial results were previously released in an NZX announcement dated 2 September 2019
from the screening of 2,065 women across 7 hospitals in Hunan Province, China.
This second preliminary trial results were presented by the lead investigator of the COGA project in Sichuan
Province at COGA’s annual congress in September 2020. The trial covered 14 hospitals and 1,243 patients
in the data analysis.
Truscreen’s results from this second phase, outlined below, were better or on parity than tests for HPV
(Human Papillomavirus DNA Test) and LBC (Liquid-cased Cytology). These results confirm Hunan
Province results announced in 2019.
Sensitivity
1
Specificity
2
PPV
3
NPV
4

Truscreen 86% 74% 52% 94%
HPV 94% 18% 27% 89%
LBC 73% 53% 34% 86%

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’s highly sensitive will indicate patients who have the disease.
2
Specificity measures correctly a negative result for people who don’t 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
Positive predictive value is the probability that subjects with a positive screening test truly have the disease.

4
Negative predictive value is the probability that subjects with a negative screening test truly don't have the disease.

Formal Publication will occur when the full 20,000 patients have been screened. Interim results from the
Sichuan and Hunan clinical evaluation validate the strong potential for the TruScreen cervical cancer
screening device to improve women’s health in China.
TruScreen Chief Executive Victoria Potarina said: “We are pleased that the Sichuan Province trial results
continued to corroborate the strong results from the first completed Hunan Province trial for the COGA
evaluation. These outstanding in-country trial results will reinforce to hospitals and key opinion leaders of
the accuracy and ease of use of our real time Truscreen cervical screening devices.”

-ENDS-

For more information, visit

www.truscreen.com or contact:

Victoria Potarina
Chief Executive Officer
victoriapotarina@truscreen.com

Guy Robertson
Chief Financial Officer
guyrobertson@truscreen.com


About TruScreen:
TruScreen cervical cancer screening device offers the latest technology in cervical screening, providing real-
time, accurate detection of precancerous and cancerous cervical cells to help improve the health and well-being
of women around the world.
TruScreen’s real-time cervical cancer technology utilises a digital wand which is placed on the surface of the
cervix to measure electrical and optical signals from the surrounding tissues. A sophisticated proprietary
algorithm framework is utilised to detect pre-cancerous change, or cervical intra-epithelial neoplasia (CIN), by
optical and electrical measurement of cervical tissue.
TruScreen offers an alternative approach to cervical screening, resolving many of the ongoing issues with
conventional Pap tests, including failed samples, poor patient follow-up, patient discomfort and the need for
supporting laboratory infrastructure. As such, TruScreen’s target market is low and middle-income countries
where no large-scale cervical cancer screening programs and infrastructure are in place, such as China, Mexico,
Africa, Russia and India. TruScreen’s cervical cancer screening device is CE-marked and certified for use
throughout Europe and NMPA approved for sale in China. The global market potential for TruScreen is
significant.