Looking at this data released to the ASX today my thoughts regading the vailidity of OvPlex ever being a viable screening tool for Ovarian cancer is confirmed.
With a false negative rate of 4.5% whilst better than CA125 the number is far too high for its viability in screening. The FDA will never approve a screening test with a false negative rate > 0.75%.
Hence this product may have legs in monitoring POST diagnosis as CA125 is currently used but application beyond this is limited.
Maximum global addressable market size realistically is therefore circa US$200m.
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ovplex cannot ever be a viable screening tool
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