15 February 2011: HealthLinx Limited (ASX:HTX) reported in December 2010 that initial analysis of part 1 of its multi-national ovarian cancer biomarker study confirmed superior diagnostic performance of OvPlex™ over CA125 in all stages of ovarian cancer including early stage disease. These and additional data were reviewed by the HealthLinx Scientific Advisory Committee (SAC) on 7 February 2011.
The company can now report that the current trial data shows that OvPlex™ maintains superior performance over CA125 when patients with benign conditions are included as part of the control group.
Data reported in December 2010 highlighted positive preliminary statistical comparisons between the current OvPlex™ panel and CA125 using normal and malignant ovarian cancer patient samples only that were derived from collaborating sites in Australia and Singapore. HTX has unique intellectual property relating to the use of the biomarker AGR2 and its potential to improve diagnostic performance was also assessed. Further analysis has demonstrated that when used to classify blood samples in the study from women with diagnosed ovarian cancer compared with normal healthy women, CA125 misclassified 50 women. When OvPlex™ was used the number of diagnostic errors was reduced by 18 (i.e. 32%). When OvPlex™ was used in combination with AGR2 the number of errors was reduced by 28 (i.e. 56%).
Importantly, the current sample analysis comprised 180 normal samples, 178 malignant ovarian cancer samples and 127 samples from women with benign gynaecological conditions. The inclusion of the benign group was designed to further test the diagnostic capacity of the OvPlex™ panel in a clinically relevant patient cohort as well as to determine the performance of AGR2 in this setting. Comparisons of area under the curve (AUC) of receiver operator curves (ROC) demonstrated a statistically significant increase in diagnostic performance of the original OvPlex™ panel over CA125 alone, with the inclusion of AGR2 adding additional benefit. Upon review of the present data, the SAC confirmed the superior performance of OvPlex™ over CA125 alone and the significantly improved performance of the OvPlex™ panel when ARG2 was included.
Taken together, previously published data (Edgell et al 2010. J Cancer Res Clin Oncol. 136: 1079) combined with the initial part of the current multi-national multi-site trial results confirm the superior performance of OvPlex™ and suggest that the further development of the OvPlex™ test can produce additional diagnostic advantage in the area of discriminating women with benign and malignant tumours. The current analysis including the benign patient cohort suggests that the use of CA125 alone would lead to 73 mistaken diagnoses within the sample set of 485 patients whereas OvPlex™ could reduce this to 51 mistaken diagnoses. This is a 30% improvement in correctly diagnosing symptomatic women, clearly demonstrating that OvPlex™ is a superior diagnostic to CA125 alone.
These initial results confirm and extend the company’s previous findings and also deliver exceptionally promising data that establishes the importance of ARG2 as an additional biomarker to improve the performance of the existing OvPlex™ test.
Based on these data and their review and ratification by the SAC, the company will (i) complete the analysis of the addition 600-700 samples in the multi-national study currently being collected; (ii) progress with the commercial development of ARG2 as a cancer biomarker; (iii) progress the integration of AGR2 into the OvPlex™ panel.
“It is clear that HealthLinx has now validated the superior diagnostic efficacy of OvPlex,” said managing director Mr Nick Gatsios.
“The pressing priority of HealthLinx with the help of its board is to drive commercial alliances that will speed the commercialisation of OvPlex™ in global markets” said Mr Gatsios.
Worldwide over 240,000 new cases of ovarian cancer are diagnosed each year while more than 130,000 women die from the disease. Ovarian cancer is the most lethal of the reproductive tract cancers. 75 per cent of women with ovarian cancer are not diagnosed until late stage disease. Their chances of surviving five years are probably only 20-30 per cent. But if the disease is diagnosed at early stage where it is contained within the ovary the chance of surviving five years rises to 80 per cent.
Nick Gatsios (HealthLinx Limited)
+61 3 9208 4200
Rudi Michelson (Monsoon Communications)
+61 3 9620 3333
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.