Australian diagnostics developer HealthLinx Limited has completed an initial Phase II biomarker trial on its second-generation ovarian cancer diagnostic that has increased the diagnostic efficiency of the panel to 98% for early stage diagnosis. This compares with the world’s most commonly used diagnostic CA125 with diagnostic efficiency of less than 60% for early stage detection.
In October, HealthLinx with ARL Pathology launched OvPlex™ 1st generation ovarian cancer diagnostic in Australia with diagnostic efficiency of 92.9%. The market interest in 1st generation OvPlex has resulted in ARL Pathology establishing a wider collection network to meet the needs of women seeking the test.
In this 2nd generation product two new novel biomarkers have been added (HTX005 and HTX010).
The study used 107 samples, 46 disease subjects, and 61 controls. The disease subjects were 35 early stage (Stage I/II) and 11 stage III results.
Specific outcomes from the study include:
1. Sample tested included 7 confirmed disease subjects where CA125 failed.
2. As individual biomarkers, HTX005 correctly identified 5 of the 7, and HTX010 correctly identified 6 of the 7.
3. Where CA125 failed to detect the 7 disease subjects (i.e. 7 false negatives) the 2nd generation OvPlex panel identified 6 of these cases. This would result in 6 of the 7 subjects being diagnosed with early stage disease and treated accordingly. All 7 false negatives were early stage cancers.
4. Samples tested included 4 high CA125 assessed as being diseased (false positives) but two were subsequently confirmed by OvPlex as without disease. CA 125 would have claimed cancer in samples where OvPlex confirmed correctly in 2 of the 4 that no cancer existed.
5. The diagnostic used 5 biomarkers and achieved diagnostic efficiency of 98.13%.
This means that the new biomarkers identified 6 subjects that had been missed by CA125 (false negatives) and eliminated 2 subjects who would have been told they had the disease but did not (false positives).
“As a company we have been focused on delivering the best ovarian cancer diagnostics in the world. These recent results support our endevours as the two new biomarkers increase the performance of OvPlex to greater than 98% diagnostic efficiency,” says Mr Nick Gatsios managing director of HealthLinx.
“Although a larger Phase II biomarker trail is required the company is confident that the result will be replicated in the larger study. The study being planned will involve 350 disease samples plus controls across multiple sites to include Asia and Europe. Once we complete this study we will make the results available and commence the scale up/manufacturing for this new product to enter the market late 2009 early 2010.”