Initial results suggest that the diagnostic accuracy of this new test will be greater than 97% for early stage ovarian cancer. The advice has come from the company’s UK collaborators and now enables recruitment of women to the study.
The trial will screen 1,150 samples using the existing OvPlex panel and an additional two novel biomarkers: AGR2 and HTX010. The study will be a robust comparison of sensitivity and specificity for the detection of ovarian cancer, particularly for early stage diagnosis in symptomatic women.
This is essential to ensure that the result is a first in class diagnostic that will be widely accepted in the global market. The company’s expectation is to increase the performance of OvPlex from the current 93% to greater than 97% for detection of ovarian cancer, and to allow earlier diagnosis of ovarian cancer patients.
The second study involves collaborators in Australia, Singapore and the UK.
Moreover, the Victorian state government is 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 of HealthLinx, said: “This was the final ethics application awaiting approval. HealthLinx will now endeavour to prove that it has the world’s first commercial and highly accurate ovarian cancer diagnostic.
“A large part of the world of oncology will be particularly interested in our two new and novel biomarkers AGR2 and HTX010. If we achieve the results we are seeking we expect that many women’s lives may be saved.”
Commercial sales of the OvPlex test have begun in Australia and are soon to commence in the UK.