Clinical Adoption And Evidence GenerationGraftAssureIQ's use at clinical sites across North America and Europe, paired with a planned 5,000-patient registry using GraftAssureCore, could build strong clinical evidence and create a recurring revenue opportunity.
Commercial PartnershipIMDX's partnership with BioRad to co-market GraftAssure in the US and Germany, with BioRad leading international commercialization elsewhere, supports wider distribution and faster global rollout.
Regulatory ProgressAnalyst noted the company is nearing completion of its FDA submission for GraftAssureDx, indicating the test is ready for formal regulatory review and could accelerate market entry upon approval.