NEW YORK (GenomeWeb News) – HealthLinx today said that Seoul Clinical Laboratories will distribute the firm's OvPlex diagnostic panel in South Korea.
SCL will begin distribution of the protein biomarkers-based test once it has received marketing approval from the South Korea Food and Drug Administration. HealthLinx said it is conducting a 220-patient study aimed at supporting its marketing application.
Under the terms of the deal, SCL will co-fund part of the study and will obtain an exclusive clinical license to distribute OvPlex in South Korea. HealthLinx said that the South Korean market for ovarian cancer diagnostics is around 250,000 tests annually.
Nick Gatsios, managing director of HealthLinx, said in a statement that SCL "has significant and well established distribution networks which will be of great advantage to ensuring OvPlex reaches the highest number of women possible in South Korea."
Melbourne, Australia-based Healthlinx launched the five-protein panel in the UK, Republic of Ireland, and Singapore earlier this year following its initial introduction in Australia in October 2008. The company has said that OvPlex is the world's first protein-based ovarian cancer diagnostic to be commercially available.
The firm noted that it also has commenced a larger study of OvPlex based on 1,150 new samples using the existing biomarkers in OvPlex as well as two new biomarkers, AGR2 and HTX010. The study aims to compare sensitivity and specificity in early-stage diagnosis in symptomatic women.