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HealthLinx Releases Initial Results from First Stage of 1,150-Subject OvPlex Study

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Australian diagnostics firm HealthLinx this week released results from the first stage of an ongoing 1,150-subject study investigating the performance of OvPlex, its protein biomarker-based ovarian cancer diagnostic.

According to an initial analysis of the first-stage data performed by Emphron Informatics, the OvPlex test was able to distinguish between stage I and II epithelial ovarian cancer patients and controls with 92 percent accuracy, compared to 80 percent accuracy for CA125, currently the standard protein biomarker diagnostic for ovarian cancer.

The results also suggest that adding two new proteins – AGR2 and HTX010 – to the test's current five-protein panel could increase its accuracy, HealthLinx said in a statement. It plans to release further data on the inclusion of these two markers in the first quarter or early second quarter of 2011. Overall, the company said it hopes in the study to demonstrate diagnostic accuracy of more than 97 percent for early stage ovarian cancer.

HealthLinx launched OvPlex in October 2008 but temporarily suspended sales in September 2009 when its domestic distributor, ARL Pathology, was acquired by the healthcare provider Healthscope. Before the pause, the company sold roughly 200 tests. It relaunched Australian sales of the test through Healthscope this June (PM 06/18/2010). It also brought the test to market in the UK in February and Singapore in July. As of Sept. 30, 2010 it had sold just over 100 tests in the UK and just over 50 in Singapore (PM 12/03/2010).

Sample collection for the second stage of the study is still ongoing in Australia, Singapore, and the UK. According to managing director Nick Gatsios, the company hopes to have the study completed within the next 12 or 14 months, after which – provided the preliminary data hold up – it plans to pursue regulatory approval for the addition of at least AGR2 to the existing OvPlex panel.

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