Clinical study validates TruScreen’s efficacy and safety for pregnant women
Leading Chinese medical publication Family Doctor confirms TruScreen’s efficacy as a cervical cancer screening tool for pregnant women, in a 2,000-patient study conducted at Guilin People’s Hospital
This is the first clinical validation of TruScreen Ultra’s use in pregnancy
The Study confirms the use to include the screening of pregnant women
TruScreen’s AI-enabled, real-time, non-invasive device was determined to be a superior choice for pregnant women compared to TCT (ThinPrep Cytologic Test) due to:
better tolerance
lower rates of post procedure bleeding
avoidance of sampling related limitations
TruScreen Group Limited (“TruScreen” or “the Company”) advises that a new study has been published in the leading Chinese medical publication The Family Doctor, validating TruScreen’s efficacy as an initial screening tool for cervical lesions during pregnancy.
This is the first study to focus on TruScreen’s use in pregnancy. The study can be viewed online here in Chinese.
In pregnancy, the cervix is fragile, increasing discomfort and bleeding risk and negatively affecting compliance and specimen quality during cervical cancer screening. The study retrospectively analyzed 2,000 pregnant women screened with TruScreen and 900 screened with TCT (ThinPrep Cytologic Test) at Guilin People’s Hospital between January 2022 and December 2024. It compared baseline characteristics, discomfort during screening, post screening vaginal bleeding, and pathology from colposcopy directed biopsy.
The study concluded that TruScreen has a high clinical value in screening pregnant women, with diagnostic performance overall similar to TCT but better tolerance and lower rates of post procedure bleeding. The authors note that pregnancy related cervical changes can impair cytology quality and increase the risk of bleeding, whereas TruScreen evaluates tissue characteristics non invasively and avoids sampling related limitations. They conclude that TruScreen improves safety, reduces anxiety and unnecessary interventions related to bleeding, and enhances follow up compliance.
The comparison between TruScreen and the Thin Prep liquid-based cytology was:
Sensitivity Specificity
TruScreen 73.7% 94.8%
TCT 71.4% 95.2%
The paper concludes that TruScreen is simple to operate, safe, well tolerated, and provides immediate results, making it a valuable supplementary and initial screening method for cervical lesions during pregnancy with good prospects for wider clinical application.
The Family Doctor is a leading print publication in China which supports China's major health policy to establish a strong primary care system.
TruScreen CEO, Martin Dillon commented:
"We are delighted to see the clinical evidence for TruScreen’s use for pregnant women presented so powerfully and its potential superiority as a screening choice. China is our largest market, with an estimated screening population of 467 million women*, so it is highly encouraging to see TruScreen’s efficacy reported by a widely circulated journal in the consumer channels in addition to our many academic clinical performance validations already conducted there and globally."
This announcement has been approved by the Board.
* CIA World Factbook (female population aged 15-64yrs)
