New Diagnostic 98% Accurate Detecting Early Stage Ovarian Cancers - 2nd Generation OvPlex™ Panel Completes Initial Phase II Biomarker Trial

Main Category: Ovarian Cancer
Also Included In: Medical Devices / Diagnostics;  Cancer / Oncology
Article Date: 08 Dec 2008 - 3:00 PDT

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Australian diagnostics developer HealthLinx Limited (ASX: HTX) 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 per cent for early stage diagnosis. This compares with the world's most commonly used diagnostic CA125 with diagnostic efficiency of less than 60 per cent 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 per cent. 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:

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 (ie 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. OvPlex™ 2nd generation used 5 biomarkers and achieved diagnostic efficiency of 98.13 per cent.

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."

1400 Australian women are diagnosed with ovarian cancer each year and more than 800 of those women will die from the disease. Worldwide 230,000 new cases are diagnosed annually with more than 142,000 disease fatalities.

HealthLinx specialises in ovarian cancer biomarkers and the development of multi-marker diagnostic tests using biomarkers. Biomarkers highlight the presence of particular compounds in blood and other body fluids that indicate disease or the effects of treatment.

Ovarian cancer develops without overt symptoms and usually by the time it has been diagnosed the cancer has spread beyond the ovaries and into the abdomen, bladder, bowel and omentum. Because there is no community-based screening test for ovarian cancer, over 75 per cent of cases are diagnosed in the advanced stages and over 80 per cent of these women will die within five years. If ovarian cancer is detected at an early stage and effectively treated, survival rate is more than 80 percent.

For information about how to purchase the test: http://www.ovplex.com.au

About HealthLinx Limited (ASX:HTX)

HealthLinx uses biomarkers to develop best practice diagnostics that detect and monitor diseases. First commercial targets are:

-- 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 targets important markets with unmet needs and is developing next generation high accuracy diagnostics and will seek to out-license to global partners for worldwide sales.

www.healthlinx.com.au