Outstanding Results from Truscreen Indian Screening Trial

Published: 14 January 2020

• TruScreen’s real-time cervical cancer screening device has demonstrated improved sensitivity and specificity targeting pre-cancerous and cancerous cervical cells compared to a Pap test in a trial in India
• India is a significant potential market for TruScreen
• The national All India Institute of Medical Sciences (AIIMS) conducted the trial involving 645 women at a tertiary referral centre in New Delhi and at a comprehensive rural health services centre at Ballabgarh, Haryana

Auckland – Real-time cervical cancer screening technology company TruScreen (NZX: TRU) or (“the Company”) says results from its first cervical cancer screening trial in India confirm that the TruScreen device is an effective, viable and non-invasive method of detecting cervical intra-epithelial neoplasia (CIN).

The trial, conducted by the All India Institute of Medical Sciences (AIIMS) in New Delhi and the town of Ballabgarh over the period January 2018 to February 2019, screened 645 women for cervical cancer.

All women in the trial underwent screening for CIN, using TruScreen’s opto-electrical device and a Pap test. The sensitivity of the TruScreen device to detect CIN was 81.82% compared to 72.73% by the Pap test. The specificity of the TruScreen device was 82.87% compared to 79.81% by the Pap test.

Sensitivity and specificity are measures of a screening test’s ability to correctly identify disease. A high sensitivity results in fewer false negatives, and a high specificity results in fewer false positives in the screening process.

“This is an important outcome for TruScreen in India, which is a significant potential market for the TruScreen real-time cervical cancer screening device,” says TruScreen Chairman Tony Ho. “TruScreen has demonstrated again to be a cost-effective solution for detecting CIN and improving the lives of women in low- and middle-income countries.”

The TruScreen device’s ability to provide test results in real time without the need to access pathology infrastructure is its distinguishing feature. In comparison, collected tissue samples from a Pap test must be processed at a pathology laboratory, where the typical turnaround time is two to six weeks. Faster test results enable patients to access follow-up reviews for medical treatment more quickly.

Results of the TruScreen trial have been submitted to the Journal of the Indian Medical Association for publication.

TruScreen thanks the AIIMS team (Principal Investigator: Prof. J. B. Sharma, Professor, Obstetrics & Gynaecology; and Co-Investigators: Prof. Alka Kriplani, Professor and Head, Department of Obstetrics & Gynaecology AIIMS, New Delhi; Prof. Sandeep Mathur, Professor, Department of Pathology, AIIMS, New Delhi) and our Indian distributors (Khandelwal laboratories) for their collaboration with the TruScreen team for this study.

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Announcements – AIIMS Results 140120.PDF