Truscreen (ASX:TRU): Taking a radical path to wide-spread commercialisation

Truscreen (ASX:TRU) is not taking the conventional path ASX medtech stocks take to market. Typically they seek approval in the US and then use that to set up shop across the world. Truscreen is instead starting its journey in Low-to-Middle Income Countries (LMICs). And even though shareholders may not realise it, this may actually be a better path for it, because while there’s no shortage of cervical screening options in the US, that is not the case in other countries.

All about Truscreen and its device

The company’s TRU system (shown below) is designed to detect the presence of pre-cancerous and cancerous tissues in the cervix, by low level electrical and optic signals. It consists of a handheld device (HHD), intelligent cradle and a single-use-sensor (SUS). The device has an expected life of 5–7 years, but the SUS is used once per test per patient in order to avoid cross-infection. 

Source: Company

The HHD collects and analyses the data and provides instant results, enabling clinicians/physicians to immediately plan appropriate patient care.  It needs no tissue samples from the cervix, nor high-quality laboratory infrastructure to process and analyse the results. 

TRU has wide application in Low and Middle-Income Countries (LMICs) where women typically lack access to cervical cancer screening. This real-time, single-visit and mobile screening technology does not require any high-cost lab infrastructure and can be conducted by a nurse or trained person based on local healthcare rules.

TRU system is presently certified for use throughout Europe and has approval for sale in China, Vietnam, Mexico, Russia, Saudi Arabia and Zimbabwe, with China being the company’s largest market. 

Slow and steady 

Has Truscreen achieved what Telix has in obtaining hundreds of millions of dollars in sales per quarter? No. But its sales are progressively growing. And

Its most recent annual sales were $2.1m, up 27%, and the next set of figures are due in a couple of months. It is not yet profitable, but has made progress from the $7.9m loss in FY22 to $2m in FY24. And in the first half of FY25, it went through 96,480 SUS units, 5% more than 12 months ago.

The company’s key market is China where it makes 78% of its sales from. Truscreen is listed on the Chinese Obstetricians and Gyneacologists Association (COGA) Blue Book and in the Chinese Society for Colposcopy and Cervical Pathology (CSCCP) Guideline.

It has dedicated manufacturing facilities – all other Truscreen devices are made in Australia. It is focused on key growth provinces including Shandong, Jiangsu, Guangdong, Hunan, Zhejiang and Guangxi. The entire country has 477m women of screening age and 158m need to be screened each year – the majority of which lie in those provinces.

Outside China it is targeting government and NGO funded programs in Zimbabwe, Vietnam, Mexico and Uzbekistan – countries with limited or no cervical cancer screening capability.

FY26 will be a big year

Yes it will. You may not get the impression right now given it is expecting stagnant revenue for its FY25 results, due in May.

But, in April 2025, the company will begin a 5-year program in Vietnam that will screen at least 260,000 women. The company is on the cusp of completing product registration for Uzbekistan and will install into 14 women’s health clinics in Tashkent shortly thereafter. Further activities are planned for Indonesia following delayed product registration.

Truscreen is certainly not a company to invest in if you expect quick bucks from the US market, but it could be one to look at if you want gradually growing revenues from a wider range of countries, where there are few other solutions (if any)

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