Part 1 of Second Study Confirms Superior Efficacy of OvPlex™ Ovarian Cancer Diagnostic

Statistical significance for early stage

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Dec 15, 2010, 10:28 ET

MELBOURNE, Australia, Dec. 15, 2010 /PRNewswire-Asia/ -- 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.

	OvPlex™	CA125	OvPlex™ Advantage (%)
All Stages (AUC)	0.938	0.902	4.0
P Value - Significant	P<0.05	-	-
Early Stage (AUC)	0.923	0.802	15.1
P Value - Significant	P<0.01	-	-
*(The diagnostic efficiency of OvPlex™ and CA125 were compared on the basis of the area under the curve (AUC) of receiver operator curves (ROC)).

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.

About HealthLinx Limited (ASX:HTX)

HealthLinx uses biomarkers to develop best practice diagnostics that detect and monitor diseases. First commercial targets are for diseases with high fatality:

Ovarian cancer diagnostic (OvPlex) targeting US$270m pa market
Prostate cancer targeting US$350m pa market

A biomarker is a specific biochemical in the body that measures disease or the effects of treatment.

HealthLinx has commenced the second larger study for OvPlex™ aiming to prove a diagnostic accuracy of over 97 per cent for early stage ovarian cancer. This larger study is based on 1150 new samples using existing OvPlex™ biomarkers and including two novel biomarkers AGR2 and HTX010. The study will be a robust comparison of sensitivity and specificity especially for early stage diagnosis in symptomatic women. The objective is to cement the position of OvPlex™ as the world's most accurate and efficient ovarian cancer diagnostic.

The second study is partially funded with $750,000 from the Victorian Government Victoria's Science Agenda Investment Fund.

www.healthlinx.com.au