COGA Trial Validates Superiority of Truscreen

NZX/ASX Announcement

5 April 2022

COGA TRIAL VALIDATES SUPERIORITY OF TRUSCREEN
CERVICAL CANCER SCREENING METHOD

• COGA Trial screened 15,661 women across 64 hospitals in 9 provinces over 3 years
• TruScreen specificity surpassed Liquid Based Cytology (LBC) and hrHPV
• TruScreen was determined to be a simple, effective and rapid real-time cervical cancer screening method
• TruScreen was determined to be an appropriate primary cervical cancer screening tool in regions with high morbidity and mortality to cervical cancer

TruScreen Group Limited (NZX/ASX: TRU) (‘TruScreen’ or ‘the Company’) is pleased to announce the release of a China-based cervical cancer screening trial which validated the superiority of TruScreen’s screening method.

The Chinese Obstetricians and Gynaecologists Association (COGA) completed a much anticipated, detailed cervical cancer screening trial that commenced in September 2018 and concluded in July 2021. The results of this trial have just been released and presented at a research conference organised by ASCCP (American Society of Colposcopy and Cervical Pathology) held in San Diego, USA. It compared the relative effectiveness of TruScreen against two other cervical cancer screening methods of HPV DNA testing (HPV) and Liquid Based Cytology (LBC).

Chinese trial highlights superiority of TruScreen screening method
The released results of the COGA trial, like those for earlier TruScreen studies, determined TruScreen to be a simple, effective and rapid real-time method to screen for cervical cancer. The COGA trial results also highlighted the superiority of TruScreen against alternative screening methods as well as the potential benefits of a TruScreen-HPV co-testing.

The size of the COGA study, which was TruScreen’s largest clinical evaluation to date, lends extra significance to its results and broad conclusions. It involved the screening in a clinical setting of 15,661 women aged 21 years and older across 64 teaching hospitals in 9 Chinese provinces. All the women included in the trial underwent primary screening with TruScreen, HPV and LBC, where levels of sensitivity and specificity were computed. The results of the study found:
• TruScreen's sensitivity was well above that for LBC (87.5% v’s 66.5%), with a high degree of statistical significance (p<0.001).
• TruScreen’s specificity (88.4%) was higher than both LBC (86.3%) and hrHPV testing (78.3%) (also at p<0.001).
• The sensitivity of TruScreen-hrHPV co-testing (carrying out with multiple types of screening tests at the same time, as opposed to a single type) was higher than that of LBC-hrHPV co-testing, 98.4% vs 95.9% (statistically significant at p=0.006).
COGA concluded that the study highlighted the superiority of TruScreen’s screening method, with the Association noting that:
• Due to resource restrictions, cytology cannot be effective in mass population screening programs in the areas with high morbidity and mortality of cervical cancer
• TruScreen minimizes the need for training and facilities and offers a real-time result
• Given the above two points, TruScreen is appropriate as a primary screening tool in regions with high morbidity and mortality to cervical cancer.

Juliet Hull, TruScreen’s Chief Executive Officer said: “Our thanks to Beijing Siweixiangtai Tech Co Ltd (SWXT), our Chinese distributor for their dedication and management of the 3-year clinical trial of our TruScreen cervical cancer screening technology. SWXT and TruScreen have achieved a significant milestone in the commercialisation of our technology in China. The validation of our technology by COGA together with the recent national price approval of our TruScreen device (NZX announcement 3 March 2022) have provided opportunities for SWXT to further expand distribution of our TruScreen cervical cancer screening technology in China. Importantly, the study’s results also point to the potential benefits of TruScreen-HPV co-testing. This is another opportunity for growth as the Company continues its successful expansion into China and other overseas markets.”

This announcement was approved for release by the Board.

-ENDS-

For more information, visit www.truscreen.com or contact:

Juliet Hull
Chief Executive Officer
[email protected]

Guy Robertson
Chief Financial Officer
[email protected]

---

Announcement PDF