Clinical Studies
20 Years of Clinical Studies with 42k Accumulated Patients

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 40,000 women in multiple settings.*

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 40,000 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.
A Performance Evaluation of an Optoelectronic Cervical Screening Device in Comparison to Cytology and HPV DNA Testing
Australia | 506 Patients
DownloadClinical evaluation of a real-time optoelectronic device in cervical cancer screening
China | 458 Patients
DownloadComparison 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
Read MoreTruScreen detection of cervical tissues for high-risk human papillomavirus-infected women during the COVID-19 pandemic
China | 1,344 Patients
Read MoreThe diagnostic accuracy of a real-time optoelectronic device in cervical cancer screening
China | Meta-Analysis | 2,730 Patients
Read MoreEfficacy of a real time optoelectronic device (TruScreen™) in detecting cervical intraepithelial pathologies: a prospective observational study
Turkey | 285 Patients
The efficacy of a real-time optoelectronic device as a diagnostic tool of over cervical intraepithelial neoplasia 1 lesion
Korea | 292 Patients
Read MoreComparing study of cervical cancer screening system and liquid-based cytology test in the screening of cervical lesions
China | 487 Patients
The assessment of real optoelectronic method in the detection of cervical intraepithelial neoplasia
Poland | 147 Patients
Read MoreA real time optoelectronic device as an adjunct to the Pap smear for cervical screening: a multicenter evaluation
Australia | 651 Patients
Read More

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

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.