Frequently asked questions 

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About the TruScreen Technology

TruScreen is a real-time, objective, AI-enabled screening device. It is CE certified as a primary screening tool. TruScreen screens for the presence of pre-cancerous and cancerous tissue in the cervix.

What is TruScreen?

TruScreen is a real-time, accurate cervical screening tool for the detection of pre-cancerous and cancerous cervical cells. As well as being accurate, the TruScreen device provides instant results, thus preventing the risk of losing contact with the patient because of the delay associated with transportation of samples to laboratories for analysis and reporting.

TruScreen is an objective, self-checking digital system that can be used with minimal training of medical or paramedical staff, and without the infrastructure and resource costs associated with cytology-based screening. Learn more about our device.

Why have we developed a new cervical screening test?

Medical professionals around the world were looking for a real-time screening device to improve accuracy and patient follow up, reduce patient discomfort and the need for supporting laboratory infrastructure and make cervical screening more available to women in remote and undeveloped regions.  In 2021 WHO acknowledged that conventional cytology based screening methods have not been successful in low- and middle- income countries. Innovative, cost-effective technology is the way forward in these markets.  TruScreen development.

How does TruScreen work?

Using a Single Use Sensor, a pen-like wand touches various spots on the cervix to pick up electrical and optical signals from the cervical tissue. The TruScreen handheld device collects this data and its AI-enabled algorithm compares it to known tissue signatures to provide an immediate result. This enables the physician to immediately plan appropriate patient care. TruScreen examinations are painless and do not require tissue samples. 

Learn more about how the device works

How long does a TruScreen test take?

Each TruScreen examination takes approximately 2-3 minutes. Real-time results are then available immediately.

Why is the Singe Use Sensor (SUS) only for single use?

By having a disposable product that touches the cervix, there is no chance of any cross-infection between patients or protein/mucus build-up on the SUS. This ensures that the result is consistent, reproducible and safe for the patient.

How long do patients have to wait for their results?

Results from the TruScreen test are available at the point of screening. Meaning that any required treatment or management plans can be formed in a timely fashion.

How accurate is TruScreen?

TruScreen has been extensively evaluated in numerous clinical studies involving more than 20,000 women. With numerous clinical trials have been completed worldwide, with the studies confirming that the overall sensitivity of TruScreen was shown to be equivalent to, if not better than, that of conventional cytology tests.

To view the published (English) clinical data for the TruScreen technology, please click here.

About cervical cancer

Cervical cancer is the growth of abnormal cells in the lining of the cervix.

How many women die from cervical cancer?

Every year 600,000+ women are diagnosed with cervical cancer and more than 340,000+ die from this disease.  Cervical Cancer is the fourth most common cancer in women worldwide, low- and middle-income countries carrying the greatest burden accounting for 85%+ of cases & deaths each year.  

How does cervical cancer develop?

Cervical cancer develops slowly and is strongly linked to Human Papillomavirus (HPV) infection, HPV is found in 99% of cervical cancer cases. Pre-cancerous cervical cells may not cause symptoms and by the time symptoms become apparent, it is often too late for treatment – particularly in resource-poor environments.

Progression of HPV infection to cancer is slow, generally taking more than 10 years. Although invasive cancer is most commonly seen in women aged over 45 years, the precursor changes are detectable much earlier through routine screening. In women with a normal immune system, it can take 15 to 20 years for invasive cervical cancer to develop.  This time is drastically reduced for women who have a compromised immune system, where it can take as little as 5 to 10 years to develop.  However, during this time the changes of the cervical tissue are detectable through routine cervical screening.

Click here for more information

Is there a relationship between HPV infections and cervical cancer?

Human papillomavirus (HPV) is the most common viral infection of the reproductive tract.   The majority of sexually active women and men will be infected with HPV at some point in their lives.  Although most HPV infections will clear on their own, there is a risk for women that an HPV infection may become chronic and lead to precancerous or cancerous lesions. 

What is the purpose of routine cervical screenings?

Cervical cancer screening involves testing for pre-cancerous or cancerous changes of the cervical tissue.  As invasive cervical cancer takes years to develop, routine screening can pick up changes in the cervical tissue at a stage where it can be easily treated.  

Organised screening programmes involve the routine testing of an asymptomatic “healthy” population.  Screening can reduce rates of both cervical cancer incidence and mortality by detecting precancerous lesions (hence preventing cancer) and detecting invasive cervical cancers at an early stage, thereby increasing patient survival.

About the TruScreen Group

TruScreen Group Limited (NZX/ASX: TRU) is a 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. 

Where can I view TruScreen Group Public Announcements?

You can review public announcement either on our website, under ASX/NZX Announcements, or on the NZX Platform, or ASX Platform.

Where does TruScreen sell its products?

After in-depth market study and evaluation, TruScreen determined that the optimal commercialisation strategy is to first penetrate low-and-middle-income countries (LMICs) where no large scale cervical cancer screening programs and infrastructure are currently in place. TruScreen is currently used in many countries around the world including; China, Russia, Saudi Arabia, Vietnam, Mexico, and Zimbabwe. Click here to view our global coverage map.

What is TruScreen's Business model?

TruScreen sells its products exclusive through our global distribution network. 

Who is TruScreen Group's Share Registry?

TruScreen Group Limited uses Link Market Services as its share registrar. For individual shareholder enquiries please contact Link using the details below:

Link Market Services Limited 
Level 11, Deloitte Centre,
80 Queen Street, Auckland, 1142.

PO Box 91976, Auckland ,1142 
+64 9 375 5998
www.linkmarketservices.com