Singapore, Dec 20, 2011: HealthLinx expects to finalize patient recruitment for its second multi-centre, multi-national OvPlex biomarker trial by the end of the first quarter 2012 after getting excellent interim results from parts one and two of the trial already analysed.

Data analysed to date are derived from a sample set comprising 222 women with malignant epithelial ovarian cancer, 53 women with confirmed borderline ovarian tumours, 223 women with benign gynecological conditions and 244 apparently healthy controls. HealthLinx previously announced that preliminary statistical analysis indicated increased diagnostic performance of the OvPlex multimarker test compared with the use of CA125 alone and that the increased diagnostic efficiency was apparent for all patients groups within the sample cohort.

Additional independent analysis by Emphron Informatics has now been performed to compare the performance of the OvPlex diagnostic with that of CA125 in terms of overall diagnostic power. The overall diagnostic power of the OvPlex test compared with CA125 was significantly better over a wide range of threshold values.

This new analysis highlights the overall enhanced diagnostic efficiency of the OvPlex multimarker test over CA125 alone at this interim stage of the trial and suggests that the data should be strengthened further once the full complement of samples is analysed. This type of analysis will be required to establish final measures of sensitivity and specificity and to establish a clinically meaningful threshold once the full sample set is collected and analysed.

“This interim analysis is very encouraging and shows a significant advantage of the multimarker test over CA125 alone for correctly classifying a broad range of patients presenting with benign, borderline tumours and early stage malignant tumours. The McNemar’s analysis focuses only on discordant results between the two tests and so it is very pleasing to see a positive result in interim sample set. The larger sample size at completion of the trial should only enhance this type of analysis” said HealthLinx Chief Scientific Officer, Dr Dominic Autelitano.

“The company could see no reason to extend the study beyond the current collection regime as the results have been exceptional” HealthLinx managing director Nick Gatsios explained. “The focus of the company now will be to obtain regulatory approvals in key markets such as the United States, China and South Korea. Any additional studies will be to satisfy regulatory requirements in respective jurisdictions.”