Australian diagnostics company HealthLinx says that it has received independent verification of the accuracy of its early-stage ovarian cancer assay, OvPlex. The finding is based on a review of data from a Phase II biomarker trial conducted late last year.
In the study, which was reviewed by independent statistics and bioinformatics firm Emphron Informatics, OvPlex demonstrated a diagnostic efficacy of 92.8%, sensitivity of 89.2% and specificity of 93.9%.
HealthLinx' managing director, Nick Gatsios, said: "93.9% specificity for early-stage ovarian cancer diagnosis is a breakthrough," adding that "our test identified four patients that were missed by CA125 [the current gold standard blood test] and eliminated 11 patients miss-classified by CA125."
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