Clinical Trial Concludes TruScreen Superior in Developing Countries

Published: 13 December 2016

A soon to be published paper demonstrates TruScreen to be an excellent test for screening for cervical cancer in developing countries.

TruScreen cervical screening

The clinical trial conducted in Mexico focused on the performance of TruScreen compared to Pap smear and HPV DNA in the real world setting of a developing country. The trial results will be presented at the 2017 World Congress for Cervical Pathology and Colposcopy in Florida, USA, in April 2017.

The paper was based on a clinical trial conducted by a noted key opinion leader in Mexico in 2016. It showed  that, in Mexico,  TruScreen was  more than 100% better  than their the Pap Smear and more than 50% better than HPV DNA in detecting high grade pre-cancerous changes to the cervix.

TruScreen is specifically targeting the marketing of its technology in developing countries where there are no large scale cervical cancer screening programmes, and the necessary infrastructure for cervical cancer screening is poor.

In Mexico, TruScreen is currently undergoing evaluation for inclusion in the National Standard for the Primary Screening of Cervical Cancer and has completed an initial pilot evaluation (obtaining excellent results) at the National Cancer Institute (INCAN) in Mexico City.

In addition, an official evaluation process has commenced for the acceptance of TruScreen as a replacement for HPV DNA testing in the primary screening of women for cervical cancer by the Ministry of Health in the State of Nuevo Leon in Mexico.  Preparatory steps have also commenced for similar adoption by Ministries of Health in other Mexican states.

The clinical trial was initiated as part of the ongoing evaluation of TruScreen for inclusion in the National Standard for the Primary Screening of Cervical Cancer in Mexico.

CEO of TruScreen, Martin Dillion, commented: “Mexico is a very large scale market opportunity for TruScreen.  The results of this clinical trial further validate TruScreen’s optoelectronic technology as a screening method for cervical cancer, particularly in developing countries, such as Mexico, where high quality cervical cytology is not available. It should greatly assist the company in its endeavours to have TruScreen included in the National Standard for the Primary Screening of Cervical Cancer in Mexico.”