TruScreen Clinical Performance Evaluation

Published: 27 September 2017

TruScreen Medical Advisory Committee Confirm Interim Clinical Evaluation Results

TruScreen Limited (NZAX: TRU) medical advisory committee (MAC) releases interim trial/ evaluation results of the company’s second generation device, TrusCreen2, which is the result of a three year product development program by the company.

A clinical performance evaluation of the new device commenced in June 2017 at the Royal Hospital for Women in Sydney, under the direction of Professor Neville Hacker, TruScreen Medical Advisory Chair, and Associate Professor Michael Campion a member of TruScreen’s Medical Advisory Committee. The aim of the study is to collect data from a total of 500 patients. At the time of writing, 200 patients, who had all been referred to the Colposcopy Clinic at the hospital, have undergone evaluation.

For patients who had no prior biopsies or treatment, the group of patients for whom TruScreen will be primarily used, TruScreen2 achieved a sensitivity of 90% for CIN2+, a specificity of 78% and a negative predictive value of 96%.

Professor Hacker stated “the results to date are promising indeed and indicate a significant improvement upon its predecessor, TrusCreen1. We plan to extend the study to rural centres in order to increase the rate of recruitment, and expect to be able to complete the study in the next 8 weeks”.

The results to date show a significant improvement over the performance of the original TruScreen 1 device. The original paper used to substantiate TruScreen1 performance in 2003 (Singer et al) showed a sensitivity of 70% for CIN2+. In addition, the most recent study with TruScreen 1, which was conducted in Mexico in 2016, reported a sensitivity for CIN2+ of 78% and specificity of 64%. In the same 2016 Mexican study, the sensitivity of cytology and HPV DNA testing were reported as just 36% and 56% respectively.

If the final results confirm these interim results, TruScreen2 will be a substantially more accurate screening method than cytology in our target markets. TruScreen CEO Martin Dillon added, “These results reinforce our advantages over the Pap smear, particularly in our target markets. The Pap test is not effective in low resource or developing health economies due to the lack of infrastructure and the highly trained personnel required to read the smear, as well as delays in reporting results.”

Associate Professor Campion commented: “I am impressed with the substantial improvement of performance of TruScreen2 to date and believe that TruScreen2 will deliver on its promise of being a unique and valuable tool in the primary screening of cervical cancer.”

Contact Martin Dillon
TruScreen Chief Executive Officer



About TruScreen:

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 tissue. A sophisticated proprietary algorithm framework  distinguishes between normal and abnormal (cancerous and precancerous) tissue to identify  precancerous change, or cervical intraepithelial  neoplasia (CIN). A Single Use Sensor (SUS) is used for each patient to protect against cross-infection.