HealthLinx reports solid data from OvPlex study

Australian diagnostic specialists HealthLinx reported today that the initial data from a second multinational study involving its ovarian cancer diagnostic OvPlex demonstrate a marked increase in diagnostic effectiveness compared to relying only on the standard CA125 blood test.

HealthLinx further reported that OvPlex showed enhanced performance in detecting for early stages I and II of the disease.

The company said that the data demonstrate “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.”

Part 1 of the current biomarker study saw the measurement of all OvPlex biomarkers in over 500 samples. Epithelial ovarian cancer patients and normal subjects (case / control) have undergone independent preliminary analysis with bioinformatics group Emphron Informatics in order to draw comparisons with HeathLinx’s previous OvPlex trial.

The key focus of the study is to undertake a ROC (receiver operating characteristic) analysis of control subjects versus all epithelial ovarian cancer patients.

HealthLinx said that a similar analysis of control subjects versus early stage ( stages I-II) epithelial ovarian cancer patients pointed to OvPlex having an ever greater advantage over CA125 alone, with initial analysis demonstrating also that the company’s two new biomarkers, AGR2 and HTX010, contributed further to the diagnostic capability.

HealthLinx said that it hoped to collect more data as to the best way to use these biomarkers to compliment OvPlex following a series of modelling studies soon to be performed with Emphron Informatics.

“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 HealthLinx managing director Nick Gatsios.

The company noted that it has already started discussions with potential commercial partners with a view to steering the AGR2-based assay through the regulatory process and then to market.

By late afternoon trade HealthLinx shares were up 4.76 percent to $0.088.