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TruScreen Group Limited (NZX: TRU) Clinical Trial Results Highlight Efficacy of TRU Technology

Wednesday 20th October 2021

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TruScreen Group Limited (NZX/ASX: TRU) (‘TRU’ or ‘the Company’) is pleased to inform the market of a study conducted in China, the results of which indicate that TruScreen’s cervical cancer screening technology has demonstrated to be an effective alternative to cervical cytology.

TruScreen matches or outperforms cytology for cervical screening

A recently published study conducted in China has confirmed the efficacy of TruScreen’s cervical cancer screening devices versus human papillomavirus (HPV) testing, cytological testing using the ThinPrep cytology test (TCT). The study recruited 458 women aged between 25 and 65 years, who received cervical cancer screening using all three methods. The clinical performance of TruScreen, alone and in combination with HPV testing, was evaluated to detect cervical intraepithelial neoplasia grade 2 or worse (CIN2+ or CIN3+).

The study concluded that for detection of CIN2+, the sensitivity and specificity of TruScreen were 83.78% and 78.86%, respectively. The specificity of TruScreen was significantly higher than those of HPV testing (50.59%, P < 0.001) and TCT (55.58%, P < 0.001). In high-risk HPV-positive women, the specificity of HPV testing combined with TruScreen was significantly higher than that of HPV testing combined with TCT (50% vs 39.9%, P = 0.004). Importantly, the sensitivity of HPV testing combined with TruScreen was comparable to that of HPV testing combined with TCT (93.94% vs 87.88%, P = 0.625). Similar patterns were also observed for CIN3+, demonstrating that TruScreen could be an alternative method to cytology.

Key findings of the study are outlined in the table below. For CIN2+, TruScreen had specificity of 78.86%, significantly higher than both HPV testing and TCT (50.59% and 55.58% respectively). TruScreen’s sensitivity of 83.78% was comparable to HPV testing and once again significantly higher than TCT (89.19% and 55.58% respectively).

The PPV for TruScreen (25.83%) was significantly higher than those for HPV testing (13.69%) and TCT (12.62%). TruScreen’s NPV figure (98.22%) was similar to that of HPV testing (98.16%) and TCT (95.90%). Similar trends were apparent for results reported for CIN3+ cases.

In women who were high-risk HPV-positive, the specificity of HPV combined with TruScreen was 50% (HPV + TCT 39.9%) the sensitivity for HPV and TruScreen combined was 93.94% (HPV + TCT 87.88%).

The study concluded that TruScreen has the potential for screening high-grade cervical precancerous lesions and may replace cytological tests as a cervical cancer screening method in China. TruScreen minimises the inherit subjectivity of interpretation of cytological tests and the dependency on pathology infrastructure.

Please see the link below for details

Clinical Trial Results Highlight Efficacy of TruScreen Cancer Screening Technology

Source: TruScreen Group Limited

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