2 December 2010, Melbourne: HealthLinx Limited (ASX:HTX) has signed binding terms sheets with the largest and most established clinical reference laboratory in South Korea, Seoul Clinical Laboratories (SCL) for the distribution of OvPlex™ in South Korea. Distribution of OvPlex™ will be able to begin upon approval from the South Korea Food and Drug Administration (KFDA) following the successful completion of the 220 patient study that began earlier this year. The terms of the deal will result in SCL co-funding part of the study and SCL will obtain an exclusive clinical license to distribute OvPlex™ in South Korea.
Seoul Clinical Laboratories (SCL) was launched in 1983 as Korea's pioneer laboratory in clinical pathology. Continuously pursuing its three core values in quality, service and research, SCL today stands as Korea's representative reference laboratory, taking a leading role in the fields of clinical diagnostics and various technology in special analytics.
“Signing binding terms sheets with a distribution partner of the calibre and reputation of SCL is what HealthLinx strives to achieve in all our distribution jurisdictions” said HealthLinx managing director Nick Gatsios. “SCL has a long history of providing quality pathology services to South Korean and other markets and as such, has significant and well established distribution networks which will be of great advantage to ensuring that OvPlex™ reaches the highest number of women possible in South Korea.”
The South Korean market for ovarian cancer diagnostics is approximately 250,000 tests annually with the disease experiencing approximately 15% annual growth. In 2004 ovarian cancer was not rated as one of the top 10 cancers however in 2009 it ranked as the 7th most prevalent and it is predicted that it will be 4 most prevalent by 2015. This translates as a significant opportunity for HealthLinx and its partners.
The 220 patient trial is being conducted by Principal Investigator Professor Byoung-Gie Kim of Samsung Medical Center and Sungkyunkwan (SKK) University School of Medicine. SKK University is one of South Korea’s most prestigious institutions while Professor Kim is also director of the Gynaecological Cancer Center at Samsung Medical Center and an opinion leader on gynaecological cancer.
2010 has been a tremendously successful year for HealthLinx in Asia with the launch of OvPlex™ in Singapore as well as starting the year by winning the Biospectrum Asia Product of the Year Award 2010.
Nick Gatsios (HealthLinx Limited) +61 3 9208 4200
Rudi Michelson (Monsoon Communications) +61 3 9620 3333
About HealthLinx Limited (ASX:HTX)
HealthLinx uses biomarkers to develop best practice diagnostics that detect and monitor diseases. First commercial targets are for diseases with high fatality:
• Ovarian cancer diagnostic (OvPlex) targeting US$270m pa market
• Prostate cancer targeting US$350m pa market
A biomarker is a specific biochemical in the body that measures disease or the effects of treatment.
HealthLinx has also commenced the second larger study for OvPlex aiming to prove a diagnostic accuracy of over 97 per cent for early stage ovarian cancer. This larger study is based on 1150 new samples using existing OvPlex™ biomarkers and including two novel biomarkers AGR2 and HTX010. The study will be a robust comparison of sensitivity and specificity especially for early stage diagnosis in symptomatic women. The objective is to cement the position of OvPlex™ as the world’s most accurate and efficient ovarian cancer diagnostic.
About Seoul Clinical Laboratories (SCL)
Seoul Clinical Laboratories (SCL) was the first commercial reference laboratory to be established in Korea and commenced operations in 1983.
With its core values based on service, quality and research it has maintained its position as a leading, and one of the largest reference laboratories in the country. SCL processes patient samples 24-hours non-stop from hospitals, private clinics and research centres nationwide, in addition to running national projects including large scale cohort research projects together with the Ministry of Health and other government entities.
In 2001, with 27 years of accumulated expertise, SCL established MOBIO, a commercial laboratory and hospital in Mongolia. Within 5 years MOBIO was selected as one the of the top 10 outstanding companies in Mongolia, with Chairman Kyoung Ryul Lee being awarded the North Star Award in Mongolia’s medical history in 2009.
SCL has strong relationships with other laboratory entities in Japan and North America with its activities extending beyond Korea into other parts of Asia. With its business expanding further globally, SCL strengthens its role to become Korea’s leading central lab and to provide a focal role as Asia’s clinical trial hub.
Further information is available on their web site at scllab.co.kr
Level 37 530 Collins Street
Melbourne VIC 3000
p: 03 9620 3333