Mass Screening Ovarian Cancer Diagnostic Would Boost Survival Rates, UK

Main Category: Ovarian Cancer
Also Included In: Cancer / Oncology
Article Date: 26 Nov 2007 - 2:00 PDT

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HealthLinx Limited (ASX:HTX), has reached an agreement with The University of Liverpool (UK) to in-license additional patented biomarker technology and antibodies that has shown efficacy in detecting grade I & II ovarian cancer.

HealthLinx and The University of Liverpool (UK) have been jointly developing this technology over the past twelve months which has potential to be the world's first commercially available, multi-marker early stage ovarian cancer diagnostic. Preliminary studies indicate detection of early stage ovarian cancer (grade I & II) and discrimination between the two major types of ovarian cancer (mucinous and serous tumors). No product with either of these benefits is available in the world today.

HealthLinx announced on 15 November the phase II biomarker results for its first generation OvPlex panel with an increase in diagnostic efficiency of ovarian cancer by greater than 15 percent compared to CA125.

"We announced last week that our first generation OvPlex panel will be made available to the Australian market in Q2 2008 by our partner ARL Pathology and in the announcement we also discussed that as a company we will strive to develop a test to detect the disease at the early stages where it is treatable and survival rates will be significantly increased," said Mr Nick Gatsios, Managing Director of HealthLinx.

"This biomarker has shown efficacy in detecting the disease at the early stages and will form the foundation of the 2nd generation OvPlex panel (ovarian cancer diagnostic). More importantly, once this panel has been designed and validated, the company will be aiming to introduce the product into the market through its partners as a 'community based screening test.'"

HealthLinx's second generation ovarian cancer diagnostic (OvPlex 2G) is being designed to detect early stage ovarian cancer, identify tumour type and be efficient for community-base screening. This diagnostic will be based on a particular compound called HTX-005 that is present in ovarian cancer samples and has demonstrated high sensitivity and specificity in detecting grade I and II ovarian cancer and discriminating tumour type.

HealthLinx will proceed with a phase 1 trial on its OvPlex 2G panel in mid 2008 and plans to then proceed with a phase II biomarker trial in late 2008.

HealthLinx specialises in ovarian cancer biomarker diagnostics. Biomarkers are specific proteins that circulate in the body that can be used to detect disease, measure disease or the effects of treatment. The technology used will rely on a simple blood test.

Global sales of the current late stage diagnostic are about US$250 million per annum and growing at over 5% per annum.

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$250m pa market; and
- Pregnancy diagnostic. This would be used in a woman's first prenatal visit to identify whether she is at high risk of having complications during pregnancy. Currently there is no product on the market which identifies complications in early stages of pregnancy.

A biomarker is a specific biochemical in the body that is used to measure progress of disease or the effects of treatment.

HealthLinx targets important markets with unmet needs. HealthLinx is developing product applications to successful Phase II biomarker trials and will then seek to out-license to partners for upfront and milestone payments and royalties on sales.

The company also has significant IP in Protein Depletion Technologies (ClearIT™) that depletes serum and other biological fluids of high abundant proteins. HealthLinx offers access to the Cryptomics Platform, which screens and identifies bio-active peptides for nutraceutical, functional foods and biological applications, on a fee for service and or collaborative basis

http://www.healthlinx.com.au

More about ovarian cancer

In the United States, females have a 1.4-1.5 percent (1 out of 70 women) chance of suffering ovarian cancer in their lives. The incidence is higher in older women. More than half of the deaths from ovarian cancer occur in women between 55 and 74 years of age. About one quarter of ovarian cancer deaths occur in women 35-54 years of age. These statistics are consistent for Australia and Europe.

The risk for developing ovarian cancer appears to be affected by several factors. The more children a woman has, the lower her risk of ovarian cancer. Early age at first pregnancy and the use of oral contraceptive pills have also been shown to have a protective effect. In contrast, the use of fertility drugs has been associated with an increased chance of ovarian cancer. Patients with a personal/family histories of breast/ovarian cancer may have elevated risk.

As the fourth largest killer of women in the western world ovarian cancer has no definitive test to determine:

(a) If in fact a women does have ovarian cancer or
(b) If cancer does exist, at what stage is the cancer ie Stages 1-4

Research groups globally have dedicated considerable resources to discover a new non-invasive test to detect the cancer in its early stage.

HealthLinx Limited

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