Clinical Trial Results Highlight Efficacy of TRU Technology

NZX/ASX Announcement
20 October 2021
Clinical trial results highlight efficacy of TruScreen cancer screening
technology
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Key Highlights
• A new study, published in the European Journal of Obstetrics and Gynaecology and Reproductive
Biology
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, concludes that TruScreen’s cervical cancer screening technology meets or exceeds the
effectiveness of alternative cervical cancer screening methods
• The study evaluated the efficacy of TruScreen in screening for cervical abnormalities, in a real world,
primary cervical cancer screening setting in China
• The TruScreen screening device was found to be very effective at detecting cervical intraepithelial
neoplasia grade 2 or worse (CIN2+ or CIN3+).
TruScreen Group Limited (NZX/ASX: TRU) (‘TRU’ or ‘the Company’) is pleased to inform the market of a study
conducted in China, the results of which indicate that TruScreen’s cervical cancer screening technology has
demonstrated to be an effective alternative to cervical cytology.
TruScreen matches or outperforms cytology for cervical screening
A recently published study conducted in China has confirmed the efficacy of TruScreen’s cervical cancer
screening devices versus human papillomavirus (HPV) testing, cytological testing using the ThinPrep cytology
test (TCT). The study recruited 458 women aged between 25 and 65 years, who received cervical cancer
screening using all three methods. The clinical performance of TruScreen, alone and in combination with HPV
testing, was evaluated to detect cervical intraepithelial neoplasia grade 2 or worse (CIN2+ or CIN3+).
The study concluded that for detection of CIN2+, the sensitivity and specificity of TruScreen were 83.78% and
78.86%, respectively. The specificity of TruScreen was significantly higher than those of HPV testing (50.59%,
P < 0.001) and TCT (55.58%, P < 0.001). In high-risk HPV-positive women, the specificity of HPV testing
combined with TruScreen was significantly higher than that of HPV testing combined with TCT (50% vs 39.9%,
P = 0.004). Importantly, the sensitivity of HPV testing combined with TruScreen was comparable to that of HPV
testing combined with TCT (93.94% vs 87.88%, P = 0.625). Similar patterns were also observed for CIN3+,
demonstrating that TruScreen could be an alternative method to cytology.
Key findings of the study are outlined in the table below. For CIN2+, TruScreen had specificity of 78.86%,
significantly higher than both HPV testing and TCT (50.59% and 55.58% respectively). TruScreen’s sensitivity
of 83.78% was comparable to HPV testing and once again significantly higher than TCT (89.19% and 55.58%
respectively).
The PPV for TruScreen (25.83%) was significantly higher than those for HPV testing (13.69%) and TCT
(12.62%). TruScreen’s NPV figure (98.22%) was similar to that of HPV testing (98.16%) and TCT (95.90%).
Similar trends were apparent for results reported for CIN3+ cases.
In women who were high-risk HPV-positive, the specificity of HPV combined with TruScreen was 50% (HPV +
TCT 39.9%) the sensitivity for HPV and TruScreen combined was 93.94% (HPV + TCT 87.88%).

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Yingting Wei, Wenjing Wang, Mengxing Cheng, Zubei Hong, Liying Gu, Jiaxin Niu, Wen Di, Lihua Qiu,
Clinical evaluation of a real-time optoelectronic device in cervical cancer screening, Yingting We et al.,
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2021, ISSN 0301-2115,
https://doi.org/10.1016/j.ejogrb.2021.09.027. (https://www.sciencedirect.com/science/article/pii/S0301211521004826)

CIN2+
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TruScreen HPV TCT
TRUSCREEN +
HPV
HPV + TCT
Sensitivity 83.78% 89.19% 55.58% 93.94% 87.88%
Specificity 78.86% 50.59% 55.58% 50.00% 39.90%
PPV 25.83% 13.69% 12.62% 22.96% 18.83%
NPV 98.22% 98.16% 95.90% 98.11% 95.40%
The study concluded that TruScreen has the potential for screening high-grade cervical precancerous lesions
and may replace cytological tests as a cervical cancer screening method in China. TruScreen minimises the
inherit subjectivity of interpretation of cytological tests and the dependency on pathology infrastructure.
TruScreen CEO Juliet Hull said: “It is pleasing to see an ever-increasing number of published studies coming
through that highlight the effectiveness of the TruScreen screening device in detecting cervical cancer. It adds
to the body of evidence already available, with a substantial amount of the publishes studies undertaken in
China, our major offshore market. But the full set of advantages the TruScreen screening device provides to
both patients and clinics do not get reflected in these studies. When measured against other screening options,
our device is non-invasive, affordable, quick, easy to learn and independent from laboratory infrastructure,
making it a cost-effective alternative to expensive cytology methods. At the same time, we remain intent on
building on these existing competitive advantages. We are now in the process of releasing a Firmware update
to TruScreen devices already in the market, which enhances their data security and more effectively interfaces
with compatible hospitals’ systems. This determination to continually evolve our unique product offering bodes
well for TruScreen’s growth potential over coming years.”
ENDS
This announcement was approved for release by the Board.

For more information, visit www.truscreen.com or contact:
Juliet Hull
Chief Executive Officer
juliethull@truscreen.com
Guy Robertson
Chief Financial Officer
guyrobertson@truscreen.com
Investor Relations
Julia Maguire

The Capital Network

+ 61 2 8999 3699

julia@thecapitalnetwork.com.au


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Specificity, with a high reading resulting in fewer false positives in the screening process. Sensitivity, where
a high sensitivity print means fewer false negatives. Positive predictive value (PPV), a gauge that examines
the probability that subjects with a positive screening test truly have the disease. Negative predictive value
(NPV), which is the probability that subjects with a negative screening test truly do not have the disease

About TruScreen:
TruScreen Limited (NZX/ASX:TRU) is a New Zealand-based medical device company that has developed a
device that can accurately detect precancerous and cancerous cervical cells in real-time via optical and
electrical measurements of cervical tissue.
TruScreen’s cervical screening technology effectively resolves many of the ongoing issues with conventional
cytology tests, including failed samples, poor patient follow-up, patient discomfort and the need for supporting
laboratory infrastructure.
The device is CE-marked, meaning it meets EU safety, health and environmental protection standards required
for sale and use throughout Europe. It is also National Medical Products Administration approved for sale in
China.
TruScreen is currently targeting product sales to a range of low and middle-income countries, including China,
Mexico, Africa, Russia and Vietnam, where no large-scale cervical cancer screening programs and
infrastructure are currently in place. By doing so, the company hopes to help improve the health and wellbeing
of women worldwide.