Singapore, Sep 1, 2010: Australia's HealthLinx has finalized research agreements with its collaborators in South Korea, to begin the 220 patient study required for South Korea Food and Drug Administration (KFDA) approval for the distribution of OvPlex.
The trial will be conducted by Principal Investigator Professor Byoung-Gie Kim of Samsung Medical Center and Sungkyunkwan (SKK) University School of Medicine. Prof Kim assisted HealthLinx in securing further key institutions to participate in the trial including Asan Medical Centre and Seoul National University Hospital. Collectively, the three hospitals have over 12,000 beds and support the three leading gynecological cancer research centres in the country.
“The commencement of the study in South Korea is excellent news for the company, and something that we have been able to bring to fruition in a relatively short time frame,” said HealthLinx Managing Director Mr Nick Gatsios. “In addition to securing distribution in the South Korean market, I believe that the study will only strengthen the scientific validity the OvPlex panel for other jurisdictions we are targeting.”
South Korea has been experiencing a greater than 10 percent growth rate in newly diagnosed ovarian cancer cases over the past four years. In 2004, ovarian cancer was not recognized as one of the top ten cancers in the country, and in a space of five years to 2009, ovarian cancer was recognized as the eighth most lethal cancer in South Korea, with projections suggesting that it could reach number five, within the next three years.
The exponential growth in newly diagnosed cases of ovarian cancer in South Korea would suggest that OvPlex has a significant market opportunity once KFDA approvals are obtained.
Mr Greg Manderson, principal of Mosaic Medical, worked with HealthLinx to secure Samsung Medical Centre as collaborators for the KFDA study. Mosaic Medical has offices in both Australia and South Korea and specializes in market entry strategy and marketing consulting for the South Korean and Australian markets.
It is anticipated that the study will take approximately 12–14 months to complete and then submissions to the KFDA will commence.
The company is also in final negotiations with one of the largest privately owned, centralized laboratories in South Korea to partner the technology for commercial distribution. When the terms sheets are finalized, the market will be informed accordingly.
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