FDA Accepts Letter of Intent for iBox Scoring System as a Surrogate Endpoint in Pharmaceutical Clinical Trials
TTC provided information supporting the qualification of the iBox Scoring System as a reasonably likely surrogate endpoint for clinical trials evaluating immunosuppressive therapies for use in kidney transplant recipients, allowing drug sponsors to purse accelerated approval. FDA indicated in its decision that it supports TTC’s intent to pursue biomarker qualification for the iBox Scoring System and invited TTC to submit a Qualification Plan.
“As a long-standing member of TTC, we appreciate the work of the consortium, the leadership shown by C-Path, and the collaborative efforts of all involved,” said
Chief Marketing Officer
Source: CareDx, Inc.