Insight Molecular Diagnostics (IMDX) Company Report

Analyst Earnings Quarterly Reports

Earnings summaries and quarterly performance for Insight Molecular Diagnostics.

Research analysts covering Insight Molecular Diagnostics.

Recent press releases and 8-K filings for IMDX.

Insight Molecular Diagnostics Prepares for GraftAssure DX FDA Submission and Commercial Transition

IMDX

Product Launch

New Projects/Investments

Guidance Update

Insight Molecular Diagnostics anticipates FDA authorization of GraftAssure DX in 2026, with a planned submission to the FDA by the end of 2025.
The company concluded Q3 2025 with $20 million in cash and equivalents and no debt, successfully keeping its cash burn below the stated $6 million per quarter goal.
Lab services revenue is projected to be sequentially flat in Q4 2025.
The company is transitioning from a development-stage to a commercial organization, focusing on driving engagement and utilization of its assay via its Nashville laboratory and pursuing strategic relationships.
The total addressable market (TAM) for kitted transplant testing is estimated to be greater than $1 billion, with potential for expansion into other organs and new testing markets like oncology.

Nov 10, 2025, 10:00 PM

IMDX Reports Q3 2025 Results and Outlines Commercialization Strategy

IMDX

Earnings

Guidance Update

Product Launch

Insight Molecular Diagnostics concluded Q3 2025 with $20 million in cash and equivalents and no debt, while keeping cash burn below its $6 million per quarter goal.
The company plans to submit its GraftAssure DX assay to the FDA in December 2025, anticipating an FDA authorization and mid-2026 launch.
IMDX is transitioning to a commercial organization, targeting a Total Addressable Market (TAM) of over $1 billion for kitted transplant testing.
Starting in Q4 2025, the company will introduce new financial reporting metrics, including adjusted EBITDA, non-GAAP net income, and non-GAAP EPS.

Nov 10, 2025, 10:00 PM

Insight Molecular Diagnostics (IMDX) Reports Q3 2025 Results, Details FDA Submission and Commercialization Plans

IMDX

Earnings

Product Launch

New Projects/Investments

Insight Molecular Diagnostics (IMDX) concluded Q3 2025 with $20 million in cash and equivalents and no debt, maintaining its cash burn below the stated goal of $6 million per quarter.
The company is on track for the FDA submission of GraftAssureDx in December 2025, with expected authorization in 2026, and is still preparing for a mid-2026 launch despite potential delays from the government shutdown.
IMDX is transitioning from a development-stage company to a commercial organization, with plans to validate heart and lung assays for reimbursement submission in 2026 and 2027, respectively.
The total addressable market (TAM) for kitted transplant testing is estimated to be greater than $1 billion, with opportunities for growth through market expansion and increased testing volumes.

Nov 10, 2025, 10:00 PM

IMDX Reports Q3 2025 Results and Progress Towards Commercial Launch

IMDX

Earnings

Product Launch

New Projects/Investments

Insight Molecular Diagnostics Inc. (iMDx) reported Q3 2025 revenue of $260,000 and a net loss of $10.9 million, or ($0.34) per share.
The company concluded Q3 2025 with a cash, cash equivalents, and restricted cash balance of $20.2 million.
iMDx remains on track to submit its GraftAssureDx product for FDA review by year-end 2025 and anticipates a mid-2026 product launch.
The company is nearing its goal of having 20 transplant centers globally engaged with GraftAssure technology by the end of 2025, with 19 centers currently participating in clinical trials or research programs.
iMDx is preparing to expand its testing capabilities beyond kidney into heart transplant testing and has initiated a 5,000-participant, multi-center registry program.