HealthLinx ready for South Korean OvPlex trial

HealthLinx (ASX:HTX) has collected the 220 patient samples required for a South Korean trial of its OvPlex ovarian cancer diagnostic test.

The study, which is required for the Melbourne-based biopharma to gain regulatory approval to sell OvPlex test kits in South Korea, will now take place over the next three to four weeks.

The results will then be analysed in a double blind case history. Full data analysis and reporting is expected to take a further two to three weeks.

The final results will then be submitted to the Korean Food and Drug Administration (KFDA).

HealthLinx's South Korean partner, Seoul Clinical Laboratories (SCL), will co-fund the trial and concurrently work towards a registration with the Health Industry Representatives Association (HIRA). This would allow OvPlex to be subsidised in the market.

Under the terms of the partnership, SCL will receive an exclusive license to distribute OvPlex in South Korea if and when KFDA approval is granted.

OvPlex is an early-stage biomarker test for ovarian cancer. HealthLinx launched the product in Australia in October 2008. It is also currently available in the UK and Ireland as well as Singapore.

In November last year, HealthLinx signed a deal that will allow Oryzon Genomics to distribute the tests in Spain, an revealed may expand the deal to also cover Portugal, Andorra, France and Italy.

The company is also preparing for 350-patient study of OvPlex in China, with an eye to launching the diagnostics test in the major market, and has selected Chinese CRO CtyogenDx to jointly conduct the trial

HealthLinx (ASX:HTX) closed Tuesday's trading unchanged at $0.009.