IMDX Posts $23M Q4 Loss, Seeks FDA Review for GraftAssureDx Assay
IMDX reported Q4 loss of $23 million (72¢/share) on $1.1 million revenue, full-year loss of $50.2 million (1.65/share) on $4.1 million revenue. The company submitted its GraftAssureDx transplant rejection assay for FDA de novo review, secured $26 million financing and engaged 37 centers covering 25% of U.S. transplants.
1. Fourth Quarter and Full Year Financial Results
Insight Molecular Diagnostics reported a net loss of $23 million, or $0.72 per share, in the fourth quarter on revenue of $1.1 million. Adjusted loss was $0.27 per share. For full-year 2025, the company posted a $50.2 million loss, or $1.65 per share, on $4.1 million in revenue.
2. GraftAssureDx FDA Submission and Clinical Engagement
Insight Molecular Diagnostics submitted its GraftAssureDx transplant rejection assay for FDA de novo review, making it the first kitted dd-cfDNA test to enter this pathway. The assay has generated favorable head-to-head data and the company is engaged with 37 U.S. transplant centers, including 28 in its registry trial, representing over 25% of annual U.S. transplants.
3. $26M Financing and 2026 Commercial Goals
In February, the company closed a $26 million financing round to fund expansion into heart transplantation testing and commercialization of kidney NASH testing. It expects U.K. CE marking in Q2 2026 and plans to transition to a commercialization stage, targeting high-margin revenue and sustained free cash flow post-authorization.