HealthLinx Announces Accuracy of Early Stage Ovarian Cancer Diagnostic Confirmed
The results published last year were based on an internal analysis of the data. The data demonstrated that the OvPlex panel achieved a better than 93 percent ovarian cancer diagnostic efficiency.
HealthLinx commissioned independant analysis and interpretation of the data where the model was used to assess its utility for early stage ovarian cancer. The validation set consisted of 37 early stage disease samples and 115 controls. The results were:
Diagnostic efficiency 92.8 percent Sensitivity 89.2 percent Specificity 93.9 percent
Further, the study was repeated in an independent laboratory and the results were reproducible.
The company appointed Emphron Informatics Pty Ltd a specialist statistical and bioinformatics company to undertake an independent evaluation on the OvPlex panel. The result of this analysis was that the OvPlex panel was statistically significant as a diagnostic test for ovarian cancer and more particularly as a diagnostic for early stage and is superior to the reference CA125.
“93.9 percent specificity for early stage ovarian cancer diagnosis is a breakthrough. All from a simple blood test,” said Mr Nick Gatsios, Managing Director of HealthLinx. “Our test identified four patients that were missed by CA125 and eliminated 11 patients miss classified by CA125. This is very important in the diagnosis of ovarian cancer and treating sufferers. Early detection means a greater than 80 percent chance of survival.”
“HealthLinx appears to have the world’s first accurate early stage ovarian cancer test. While Ovplex was compared with the current ovarian cancer reference CA 125 It should be noted that CA 125 is used mainly for diagnosing late stage ovarian cancer, treatment monitoring and disease progression not as an early stage diagnosis tool. CA125 early stage diagnostic accuracy is less than 60 percent whereas OvPlex is over 93 percent.”
“The other good news is that OvPlex will be selling in Australian by the 3rd quarter this calendar year.”
The Phase II biomarker trial was conducted with ARL Pathology using 362 blood samples as detailed in the November 2007 release. HealthLinx is in discussion with global diagnostic groups for exclusive distribution of the panel in the US, Asian and European markets.
HealthLinx specialises in ovarian cancer biomarkers and the development of multi-marker diagnostic tests using biomarkers. Biomarkers highlight the presence 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 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.
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.
Global sales of the current late stage diagnostic are about US$260 million per annum.
Enquires:
Nick Gatsios, HealthLinx Limited 03 9208 4200 Rudi Michelson (Monsoon Communications) 03 9620 3333
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$260m 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.
www.healthlinx.com.au