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By June Ramli
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Sydney, August 1: TruScreen Group Limited (NZX/ASX: TRU) is an Australia and New Zealand-based medical device company that has developed an AI-enabled device that can detect precancerous and cancerous cervical changes in real-time via optical and electrical measurements of cervical tissue. Unlike many cervical screening devices that have only triage/adjunct functionality, the TruScreen device is registered as a primary screening tool. TruScreen’s cervical screening technology effectively resolves many of the ongoing issues with conventional cytology, 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, Vietnam, Russia, Saudi Arabia and, Zimbabwe, 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.
In an exclusive interview with DailyStraits.com, TruScreen CEO, Juliet Hull tells us more about the company’s offering and its business plans moving forward. Without further ado, let’s read the interview here:
What is TruScreen, how much does it cost and where is it sold now?
TruScreen provides an accurate, real-time cervical cancer screening solution. Our primary screening solution is ideal for communities that cannot access conventional, laboratory dependant, screening methods. It is affordable and easy to learn. Cervical cancer is unique in that it is highly preventable if regular screening is done and pre-cancerous cells can be detected. Pricing differs between different markets, however, it is generally much lower compared with traditional lab-based screening, which is much more resource and infrastructure intensive. TruScreen is currently sold in China, Russia, Mexico, Vietnam and Zimbabwe.
Tell us how does TruScreen work?
TruScreen uses unique, proprietary optoelectrical technology to evaluate the tissue of the cervix. Unlike cytology, TruScreen does not only examine surface epithelial cells. And unlike human papillomavirus (HPV) testing, it tests for the actual presence of precancerous/cancerous cells, not just the current or future possibility of such cells forming.
Specific frequencies of light are transmitted through the cervical tissue to identify changes in the basal and stromal layers. Electrical measurements test the cell’s resistance to current to characterise the tissue. The optical and electrical measurements taken together throughout a screening are analysed by an integrated AI-enabled algorithm, which will determine if the cervical tissue is “normal” or “abnormal” (precancerous/cancerous). The device completes this analysis immediately, providing the patient’s objective results at the point of screening.
Do you have a competitor in Australia or New Zealand?
TruScreen is a unique cervical cancer screening device, with no direct competitors as such. In Australia & New Zealand, the competitors would be HPV testing and Liquid-Based Cytology (LBC).
Where is TruScreen made?
TruScreen is designed and manufactured in Australia, with the consumable component of the system manufactured in China. Some devices are also set to be manufactured in China, with the recent commissioning of a new manufacturing facility.
Do you have any figures to show the effectiveness of TruScreen?
The Chinese Obstetricians and Gynaecologists Association (COGA) completed a much anticipated, detailed cervical cancer screening trial that commenced in September 2018 and concluded in July 2021. The size of the COGA study, which was TruScreen’s largest clinical evaluation to date, lends extra significance to its results and broad conclusions. It involved screening in a clinical setting of 15,661 women aged 21 years and older across 64 teaching hospitals in 9 Chinese provinces. All the women included in the trial underwent primary screening with TruScreen, HPV and LBC, where levels of sensitivity and specificity were computed. The results of the study found: that TruScreen’s sensitivity was well above that for LBC (87.5 per cent v’s 66.5 per cent), with a high degree of statistical significance (p<0.001). TruScreen’s specificity (88.4 per cent) was higher than both LBC (86.3 per cent) and hrHPV testing (78.3 per cent) (also at p<0.001). The sensitivity of TruScreen-hrHPV co-testing (carrying out with multiple types of screening tests at the same time, as opposed to a single type) was higher than that of LBC-hrHPV co-testing, 98.4 per cent vs 95.9 per cent (statistically significant at p=0.006).
Why the company is focusing on lower-middle-income countries (LMICs)?
The TruScreen device resolves many of the ongoing issues associated with traditional screening methods, including failed samples, poor patient follow-up, patient discomfort, and the need for supporting laboratory infrastructure. It also resolves the problems associated with HPV testing, which tests for the much more prevalent HPV virus, and not the presence of pre-invasive cervical cancer states. These issues are particularly pertinent in LMICs, which is why these are such key markets for TruScreen.
Why does cervical cancer still carry a stigma?
Cervical cancer in many cultures can still carry a stigma. This is possible because the vast majority of cervical cancers are caused by HPV, which is a sexually transmitted infection. This potentially makes it difficult to carry out education about the importance of regular screening and can also make it challenging to discuss treatment options once it has been diagnosed.
And, what is TruScreen’s focus for the rest of the year, including its expansion plans?
A primary focus will be China, as the COVID situation continues to improve in what is currently TruScreen’s biggest market. Following the announcement of the COGA results, we expect to see increasing adoption of TruScreen in China, supported by a range of in-market activities. Other markets that we will continue to focus heavily on this year include Zimbabwe, Mexico and Vietnam, where there are opportunities to experience rapid uptake and growth.
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June Ramli is the editor of DailyStraits.com. To stay in touch with June, look her up on Twitter @junesairaramli