HealthLinx Achieves Improved Ovarian Cancer Diagnostic In Phase II Trial, Australia
The study was conducted in partnership with ARL Pathology and the Women's Cancer Foundation using almost 400 blood samples that were collected over the past 18 months.
It is anticipated that ARL Pathology will offer the OvPlex diagnostic in the market in Q2, 2008 and discussions are being held with global diagnostic groups for US, Asian and European markets.
HealthLinx specialises in ovarian cancer biomarkers and the development of multi-marker diagnostic tests. Biomarkers are specific substances (including, proteins or peptides) that provide information about the presence of disease. HealthLinx focuses on biomarkers that are present in blood and other body fluids that can be used to detect and/or monitor 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 percent of cases are diagnosed in the advanced stages and over 80 percent of these women will die within 5 years. If ovarian cancer is detected at an early stage and effectively treated, survival rate is more than 80 percent.
The incidence of ovarian cancer is higher in women over 40. In the US about 23,000 women were diagnosed last year with about 14,000 deaths. The percentage is similar in Western Europe and Australia. In Australia, there were about 1,300 new cases of ovarian cancer diagnosed and over 900 deaths reported.
"The trial results have exceeded our trial design and expectations and as a company we are pleased with these results". said Mr Nick Gatsios, Managing Director of HealthLinx. "It gives women hope by increasing the effectiveness of detection at mid to late stage of the disease and disease recurrence."
"HealthLinx is now positioned to further develop its OvPlex assay into the world's best ovarian cancer diagnostic. The prospect of a simple blood test providing high diagnositic accuracy for ovarian cancer is a very significant event in oncology".
"We have a path to market with our partners ARL Pathology for the Australian and New Zealand markets and we are also in discussion with a number of global groups who have the capacity to scale up and distribute into key markets including the US, Asia and Europe."
Global sales of the current late stage diagnostic are about US$250 million per annum and growing at over 5 percent 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
- Pregnancy diagnostic. This would be used in a woman's first prenatal visit to identify whether she is at high risk of pregnancy complications. Currently there is no product on the market for 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 a fee for service to access the Cryptomics Platform that screens and identifies bio-active peptides for nutraceutical, functional foods and biological applications.
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.
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