Clinical application of ISO and CEN/TS standards for liquid biopsies - information everybody wants but nobody wants to pay for

Abstract

AbstractBackgroundLiquid biopsies are emerging as valuable clinical biomarkers for cancer monitoring. Despite increasing clinical use, standardization remains a challenge. ISO and CEN/TS standardized workflows exist, but their integration into clinical practice is underdeveloped. We aimed to assess the applicability of ISO and CEN/TS liquid biopsy standards in a real-world clinical setting.MethodsWe evaluated 659 peripheral blood samples from advanced prostate cancer patients against ISO and CEN/TS standards and tracked all essential criteria. This included assessing tube filing level, complete timing from blood draw until storage, transport conditions, temperature control, hemolysis score and tube draw order and its effects on hemolysis.ResultsAmong 659 samples, 92.4% (609/659) met the essential criteria for ISO and CEN/TS compliance. In total 83.8% (552/659) of blood collection tubes had high fill levels above 80% of nominal filing level. In our advanced prostate cancer cohort, 12.9% (40/311) of the evaluated plasma samples were hemolytic. Within the draw order of five blood collection tubes, hemolysis did not significantly increase from tube one to five. The complete ccfDNA ISO and CTC CEN/TS workflows were completed within an average of 168 (+/- 71 min) and 248 minutes (+/- 76 min), respectively, from blood draw until storage.ConclusionsOur study demonstrates the feasibility and benefits of adhering to ISO and CEN/T standards in a clinical liquid biopsy study. ISO and CEN/TS standards revealed that hemolysis is a common phenomenon in pre-treated advanced prostate cancer patients, as we eliminated pre-analytical errors as cause.