• Second phase of national clinical trial in Sichuan Province reported outstanding results
• Conducted by China Obstetrics and Gynaecology Association (COGA) a peak gynaecology body in China.
• Trial conducted across 14 hospitals with 1,243 patients participating
• Both sensitivity and specificity targeting pre-cancerous and cancerous cervical cells performed in aggregate better than other screening methods (see below table)
This second preliminary trial results were presented by the lead investigator of the COGA project in Sichuan Province at COGA’s annual congress in September 2020. The trial covered 14 hospitals and 1,243 patients in the data analysis.
Truscreen’s results from this second phase, outlined below, were better or on parity than tests for HPV (Human Papillomavirus DNA Test) and LBC (Liquid-cased Cytology). These results confirm Hunan Province results announced in 2019.
Truscreen had a Sensitivity of 86% (HPV 94%, LBC 73%) Specificity of 74% (HPV 18%, LBC 53%) PPV 52% (HPV 27%, LBC 34%) and NPV 94% (HPV 89%, LBC 86%).
Formal Publication will occur when the full 20,000 patients have been screened. Interim results from the Sichuan and Hunan clinical evaluation validate the strong potential for the TruScreen cervical cancer screening device to improve women’s health in China.
TruScreen Chief Executive Victoria Potarina said: “We are pleased that the Sichuan Province trial results continued to corroborate the strong results from the first completed Hunan Province trial for the COGA evaluation. These outstanding in-country trial results will reinforce to hospitals and key opinion leaders of the accuracy and ease of use of our real time Truscreen cervical screening devices.”
Sensitivity measures correctly a positive result for patients who have the condition that is being tested for (also known as the “true positive” rate). A test that’s highly sensitive will indicate patients who have the disease. Specificity measures correctly a negative result for people who don’t have the condition that is’ being tested for (also known as the “true negative” rate). A high-specificity test will correctly rule out patients who do not have the disease. PPV - Positive Predictive Value is the probability that subjects with a positive screening test truly have the disease. NPV - Negative Predictive Value is the probability that subjects with a negative screening test truly don't have the disease.