Regulatory ApprovalIMDX reaffirmed its goal to submit its GraftAssureDx kidney test to the FDA by the end of 2025, and expects to obtain FDA approval around mid-2026.
Revenue OpportunitiesIMDX also announced a large 5,000 patient registry utilizing GraftAssureCore (laboratory developed test), which could provide additional revenue.
Strategic PartnershipsIMDX remains confident in its partnership with BioRad, whereby BioRad and IMDX will comarket GraftAssure inside the US/Germany, and BioRad will take the commercial lead in the rest of the world.