positive findings in south korean study for ov

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
Positive Findings in South Korean Study for OvPlex™
27th June 2012, Melbourne: HealthLinx Limited (ASX:HTX) announced today that preliminary analysis 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 shown a significant advantage over the use of CA125 alone.
The samples were analysed for the five OvPlex™ biomarkers in a blind fashion by Seoul Clinical Laboratories (SCL) and
the anonymous raw data was then used to generate an OvPlex™ probability score. Mosaic Medical Pty Ltd has acted as
trial coordinators on behalf of Healthlinx and has maintained the anonymity of the sample collection until after analysis
was complete. 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 OvPlex™ provided a statistically significant advantage over the use of CA125 alone,
particularly with respect to correctly classifying patients with benign gynaecological conditions. That is, the use of
OvPlex™ reduced the number of false positive diagnoses when compared to CA125 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.
“These interim results are very exciting. This is a further independent sample set that have been through the OvPlex™
algorithm and again the fact that the OvPlex™ test delivered a statistically significant improvement over CA125 alone has
been demonstrated” says Nick Gatsios, managing director. “Clearly the final results will be driven by the completion of the
larger multi centre, multi national study but this is still very exciting and encouraging to see that OvPlex™ reduces the
false positive rates significantly over CA125 alone.”
The outcome of the trial will also be reviewed in detail by the Principal Investigator, Professor Byoung-Gie Kim of
Samsung Medical Center. Upon its successful completion a formal submission to the KFDA will follow and SCL who are
co-funding the study will obtain an exclusive license to distribute OvPlex™ 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 4th most prevalent by 2015. This
translates as a significant opportunity for HealthLinx and its partners.