TruScreen’s Clinical Performance

As TruScreen’s results come from an objective, self-checking digital system, they are free of the highly subjective human judgment required for cellular diagnosis on conventional screening methods, such as Pap Smears.

TruScreen can be effectively used with minimal training of medical, or paramedical staff, to allow cervical cancer detection without the infrastructure and resource costs associated with conventional, cytology-based screening. TruScreen is also more acceptable to women than a conventional Pap test.

The TruScreen device has been clinically validated, with large clinical studies including over 20,000 women in multiple settings.*

Frequently Asked Questions
Clinical Performance and Studies

TruScreen offers an alternative approach to cervical screening, resolving manty of the ongoing issues with conventional screening methods including failed samples, poor patient follow up, patient discomfort and the need for supporting laboratory infrastructure.

As TruScreen’s results come from an objective, self-checking, AI-enabled system, they are free from the highly subjective human judgement that conventional screening methods are so reliant on.  The TruScreen device has been clinically validated, with large clinical studies including over 20,000 women in multiple settings.*

TruScreen can be effectively used with minimal training to allow for cervical cancer screening without the infrastructure and resource costs associated with conventional, cytology based screening.

As a vast majority of clinical evaluations and trials are conducted in our key markets, there is a large volume of papers that are only available in the native language of the publication’s region.

Below are some English published papers on TruScreen that are available in the public domain. 

Published Papers

2021

Clinical evaluation of a real-time optoelectronic device in cervical cancer screening

CHINA | 458 patients

2020

Comparison of the detection rate of cervical lesion with TruScreen, LBC test and HPV test: A Real-world study based on population screening of cervical cancer in rural areas of China

CHINA | 9,972 PATIENTS

2020

TruScreen detection of cervical tissues for high-risk human papillomavirus-infected women during the COVID-19 pandemic

CHINA | 1,344 PATIENTS

2018

The diagnostic accuracy of a real-time optoelectronic device in cervical cancer screening

CHINA | META-ANALYSIS | 2,730 PATIENTS

2011

Optoelectronic method for detection of cervical intraepithelial neoplasia and cervical cancer

POLAND | 293 PATIENTS

2010

The efficacy of a real-time optoelectronic device as a diagnostic tool of over cervical intraepithelial neoplasia 1 lesion

KOREA | 292 PATIENTS

2009

Comparing study of cervical cancer screening system and liquid-based cytology test in the screening of cervical lesions

CHINA | 487 PATIENTS

2008

The assessment of real optoelectronic method in the detection of cervical intraepithelial neoplasia

POLAND | 147 PATIENTS

2003

A real time optoelectronic device as an adjunct to the Pap smear for cervical screening: a multicenter evaluation

AUSTRALIA | 651 PATIENTS

TruScreen’s Development

Pioneering research and development on the TruScreen cervical cancer screening system for real-time cervical tissue differentiation has involved close collaboration with leading clinicians and hospitals across the world.

Development History

TruScreen Device Overview

TruScreen is a real-time, objective 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.

TruScreen Device Overview
*Total number of subjects across published clinical studies in English, data from TruScreen device generation I and II.
Reference: Data on File, December 2020