Table 3.

Biopsy-based Transcript Diagnostics Working Group (formerly “molecular diagnostics”): Validation plan.

• Since no transcript has diagnostic specificity (similar to Banff histologic lesions), consensus thresholds for molecular classifiers and gene sets associated with Banff lesions and diagnosis need to be established and validated for defined clinical context(s) of use

• What is the Analytical Validity of different molecular assays?

○ Reproducibility and normalization/calibration studies are needed to make molecular results comparable between centers and sequential biopsies

○ Head-to-head comparisons of different assays on the same biopsy are needed to allow conversion of results from different platforms.

• What is the clinical validity of different molecular assays?

○ Comprehensive multicenter (not only biopsies from different centers, but assays run at different centers on the same biopsies) and multiplatform studies of well-annotated cohorts including the full spectrum of the diseases and controls (including native kidneys/recurrent diseases) need to be conducted.

• What is the clinical utility of different molecular assays?

○ Diagnostic vs prognostic vs theragnostic claims need to be validated in prospective or retrospective, randomized trials showing improved outcomes using molecular tests

○ Health-economic parameters need to be assessed to demonstrate value for money of molecular tests in kidney transplant care.