Diagnostic company HealthLinx Limited (ASX: HTX) reports that initial analysis of part 1 of its multinational ovarian cancer biomarker study confirms a statistically significant increase in diagnostic performance of OvPlex™ over CA125 alone. Enhanced performance of OvPlex™ was also established specifically for early stage (Stage I-II) disease.
These data represent preliminary statistical comparisons of area under the curve (AUC) of receiver operator curves (ROC) generated from Part 1 of the second larger multi-national, multi-centre biomarker study. Biomarker measurements in over 500 samples have been completed to date, which represents a subset of the full OvPlex™ study that will include a total of 1150 samples which will be collected in Australia, Singapore and the United Kingdom.
Measurement of all OvPlex™ biomarkers was performed in over 500 samples as part 1 of the current biomarker study and the epithelial ovarian cancer patients and normal subjects (case / control) have undergone independent preliminary analysis (Emphron Informatics Pty Ltd) in order to draw comparisons with our previous OvPlex™ trial. The primary end point for the study is to undertake a ROC analysis of control subjects versus all epithelial ovarian cancer patients. Part 1 of the study demonstrated that OvPlex™ significantly outperformed the diagnostic capability of CA125 alone.
Similar analysis of control subjects versus early stage (stages I-II) epithelial ovarian cancer patients demonstrated an even more marked advantage of OvPlex™ over CA125 alone as detailed in the table above. Initial analysis also demonstrates that the two new biomarkers AGR2 and HTX010 add further diagnostic potential to the panel.
Overall, the findings so far demonstrate in a totally independent and broader sample set that OvPlex™ has similar or better performance to our previous biomarker trial and provides strong confirmation of the advantage OvPlex™ provides over the use of CA125 alone. The performance of OvPlex™ is increased further when either of the company's two new biomarkers AGR2 or HTX010 is included in the panel and the best possible way to exploit their diagnostic value will be determined in the upcoming series of modelling studies to be performed with Emphron Informatics. Full details of these results will be made available late first quarter or early second quarter next year due to the level of additional analysis required.
"Based on these preliminary data the company will progress the AGR2 assay through regulatory approval for use in the panel once this OvPlex™ study is completed," said managing director Mr Nick Gatsios.
The company has commenced discussions with commercial partners which have the internal resources and expertise to take the research based AGR2 assay through the regulatory pathway and scale up production for commercial distribution.
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