SJURVM schreef op 7 juni 2017 08:07:
[...]
"Prospective data on utility should be available after completion of PASCUAL. No data is available on the longer term clinical outcomes of the men who did not have biopsy based on ConfirmMDx results. The indirect chain is incomplete.
Section Summary
Two clinical validation studies have reported on clinical validity of the ConfirmMDx score in the intended use population. The studies did not provide estimates of validity compared to a standard clinical examination with %fPSA. No data is available on the long term clinical outcomes or clinical utility of the test. The indirect chain of evidence is incomplete due to the
limitations in evidence on comparative clinical validity and utility"