HealthLinx (ASX: HTX) is moving closer to expanding sales of its first-in-class ovarian cancer diagnostic test, OvPlex™, to another jurisdiction with positive preliminary findings from an analysis of 220 patient samples required for a pivotal Korean Food and Drug Administration (KFDA) study.
This study is important because it paves the way for HealthLinx to seek regulatory approval of OvPlex™ in yet another jurisdiction, South Korea.
OvPlex™ has already been approved for sale and is available in the UK, Australia, Singapore and Malaysia. First sales of the test will begin in India from August, and in Spain in the second half of this year.
OvPlex™ is a diagnostic test that measures levels of five proteins in a patient’s blood. One of the proteins is CA125, which has been used for several years for the detection and monitoring of ovarian cancer.
Nick Gatsios, managing director, told Proactive Investors today while the results are preliminary in nature, they demonstrate statistical significance.
“If it holds up with the final algorithm then we have obtained statistical significance in every study that we’ve run, and every study has had a different population, a different patient cohort all targeting that symptomatic woman who presents with symptoms of ovarian cancer, and each time we have statistical significance.
“So I guess that’s the real benefit to the company in that the technology is being proved up again and again and again.”
The samples were analysed for the five OvPlex™ biomarkers in a blind fashion by Seoul Clinical Laboratories and the anonymous raw data was then used to generate an OvPlex™ probability score.
A new diagnostic algorithm generated from interim data collected from 742 patient samples from the ongoing OvPlex™ multinational trial was used to predict the status of the South Korean sample cohort.
The interim analysis demonstrates that the use of OvPlex™ reduced the number of false positive diagnoses when compared to the CA125 test alone.
Final analysis of the Korean trial data will take place after completion of the current multinational OvPlex™ trial and implementation of the new diagnostic algorithm.
Upon the successful completion of the South Korean study a formal submission to the KFDA will be made.
Seoul Clinical Laboratories, who are co-funding the study, will then obtain an exclusive licence to distribute OvPlex™ in South Korea.
Gatsios said completion of the South Korean study is dependent on the completion of multi-centre, multinational study, which should be completed in the next two months.
HealthLinx will then be able to finalise the South Korean study and move towards commercialisation.
South Korean market potential
The South Korean market for ovarian cancer diagnostics is about 250,000 tests annually with the disease experiencing around 15% annual growth.
The OvPlex™ panel is being sold for $200 in Australia compared to CA-125 which has a postreimbursement cost of $40.
Ovarian cancer is forecast to be the fourth most prevalent cancer by 2015, compared to the seventh most prevalent cancer in 2009. This translates into a major market opportunity for HealthLinx.
The ovarian cancer market is estimated to be around US$270 million per annum.
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