HealthLinx LimitedABN 88 098 640 352576 Swan Street Richmond VIC...

HealthLinx Limited
ABN 88 098 640 352
576 Swan Street Richmond VIC 3121
Telephone: +61 3 9208 4200 I Facsimile: +61 3 9208 4201
www.healthlinx.com.au
Pivotal South Korean KFDA Study for OvPlex™ Ready to Commence
20 March 2012, Melbourne: HealthLinx Limited (ASX:HTX) announced today that recruitment of the minimum target of
220 patient samples required for the pivotal Korean Food and Drug Administration (KFDA) study to obtain regulatory
approvals for OvPlex™ in South Korea has been completed. The samples have now been sent to Seoul Clinical
Laboratories (SCL) HealthLinx’s commercial partner for the South Korean market for storage and coding prior to the study
commencing.
Measurement of the OvPlex™ markers is expected to take place over the next 3 -4 weeks and data will then be analysed
in a double blind case history prior to the sample code being released by Mosaic Medical Pty Ltd who are acting as trial
coordinators on behalf of Healthlinx. It is expected that full data analysis and reporting of the outcomes can be
accomplished within 2-3 weeks of receiving the decoded data set. The trial outcomes will then be reviewed in detail by
the Principal Investigator of the trial, Professor Byoung-Gie Kim of Samsung Medical Center after which a formal
submission to the KFDA will take place. Under the terms of the agreement, SCL are co-funding the study and, upon its
successful completion, will obtain an exclusive license to distribute OvPlex™ in South Korea.
“As a company we are very excited about this event. This is a critical element in value creation for the company and its
assets and, upon a successful outcome, OvPlex™ will have entered a 6th jurisdiction with full regulatory registration,” said
HealthLinx managing director Nick Gatsios. “SCL will also work towards obtaining Health Industry Representatives
Association (HIRA) registration that will allow the product to obtain reimbursement from government and insurance
companies”.
“The company would like to thank Principal Investigator Professor Byoung-Gie Kim of Samsung Medical Center and
Sungkyunkwan (SKK) University School of Medicine for his expert coordination of the trial and assistance with recruiting
and collaborating with ASAN Medical Centre and Seoul National University Hospital to collect the samples,” Mr Gatsios
added.
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 4th most prevalent by 2015. This
translates as a significant opportunity for HealthLinx and its partners.