iMDx submits GraftAssureDx to FDA; Q4 revenue $1.1M, net loss $23.0M

Insight Molecular Diagnostics Inc.

Submitted GraftAssureDx kidney transplant test to FDA on March 25; expects 150-day review and authorization this year.
Full year 2025 revenue $4.1M (up from $1.9M); Q4 revenue $1.1M, net loss $23.0M ($0.72/share).
Adjusted Q4 net loss $8.7M ($0.27/share); R&D expenses rose 50% sequentially to $5.8M due to FDA submission.
Impaired oncology intangibles $14.6M ($11.7M DetermaCNI, $2.9M DetermaIO) to focus on transplant.
Appointed Dr. Nick Ioannou as VP Medical Affairs; completed $26M financing in February for heart expansion.

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