HealthLinx has secured over 400 of the first 450 samples required for its study of the OvPlex ovarian cancer diagnostic. The remainder have been sourced and are expected to be available in the near future.
HealthLinx said that the study will be run in two stages, stage one of the study is expected to commence late 1st quarter early second quarter this year with results due by the middle of the calendar year. The second stage will commence when the remaining 700 samples are collected at the clinics in Australia and the UK on an ongoing basis now that human ethics approval has been finalised at these sites.
The multinational study is being conducted with collaborators in Australia, Singapore and two sites in the UK. The study for the ongoing development of OvPlex is aiming to prove a diagnostic accuracy of over 97% for early stage ovarian cancer.
The testing on 1150 new samples using the existing OvPlex panel, two biomarkers AGR2 and HTX010 will also be used to assess their utility in the panel. The study will be a comparison of sensitivity and specificity especially for early stage diagnosis in symptomatic women.
The Victorian State Government has been funding part of the study through its VSA Grants program. HealthLinx secured $750,000 funding from the program in November 2009 and executed agreements with the State Government in January 2010.
Nick Gatsios, managing director, said: “With participating clinical centres for the study now locked in, we are ready to engage their expertise in further proving the performance of OvPlex as a viable and accurate ovarian cancer diagnostic. We believe that it will be especially effective in detecting earlier stage ovarian cancer and this is where there is substantial life-saving potential.”