OvPlex is a diagnostic test that measures the levels of five proteins in a patient's blood. One of the proteins is CA125, which has been used for several years for the detection and monitoring of ovarian cancer. When measured along with the four additional proteins that make up OvPlex, a significant enhancement in diagnostic performance can be achieved.

OvPlex uses the minimally invasive methodology of a simple blood test. Performance of the OvPlex multimarker test is based on retrospective biomarker trial of 362 samples consisting of 150 patients with confirmed ovarian cancer and 212 patients were free of disease. Based on the analysis of receiver operator characteristic (ROC) curves, OvPlex significantly out performs the CA125 blood test, for both early and late stage disease.

For the detection of ovarian cancer, OvPlex delivers 94 percent specificity, 94 percent sensitivity and an overall diagnostic efficiency of 94 percent when used at a threshold of 0.45. OvPlex reduces the overall false negative rate by up to 19 percent and the false positive rate by 42 percent when compared with using CA125 alone. For the detection of early stage (stages I and II) disease, the OvPlex multimarker test also outperformed the use of CA125 alone, delivering 92 percent sensitivity and 94 percent specificity in the biomarker trial. The enhanced performance of OvPlex, particularly with respect to detection of early stage ovarian cancers suggests that it will provide significant benefits in terms of diagnostic performance over the use of CA125 alone.

Benefits of team work

Over the last few years, a small group of 6-8 scientists at HealthLinx have formed the core development team involved in bringing the OvPlex diagnostic to fruition. The laboratory development has involved input from scientific research staff with broad expertise in the areas of protein purification, analysis and characterization, mass spectrometry and immunoassay development. These laboratory skills, coupled with the ongoing advice and support from the clinical and academic advisors, have supported the successful development of the OvPlex product.

Commenting on developing such a unique product, Mr Gatsios, says, "We have invested approximately 70 percent of our funding over the past few years, for evaluating the novel biomarkers AGR2 and HTX010. I am proud of our research team as OvPlex was the result of work done by HealthLinx staff. During the development of the OvPlex panel HealthLinx entered into collaboration to access clinical samples with a number of medical institutions in Australia."

The development path has also led to the implementation of the current multi-marker composition that was shown to provide the best combination for outperforming CA125 for the detection of all ovarian cancers as well as early stage ovarian cancer in the recent phase II biomarker trial. The research and development team continues to characterize and test other potentially useful biomarkers with the aim of further refining the sensitivity and specificity of the OvPlex product.