iMDx posts Q2 loss as FDA review of GraftAssureDx continues

Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) reported a net loss of $11.3 million, or $0.31 per share, for the second quarter ended June 30, 2026, as the Nashville-based company continues to await FDA marketing authorization for its GraftAssureDx transplant diagnostic kit.

Revenue for the quarter was approximately $239,000, down from $518,000 in the same period a year earlier. Gross profit was $157,000, representing a gross margin of 65.7%. Operating expenses totaled $11.6 million, including a non-cash charge of $2.3 million related to a change in the fair value of contingent consideration and $661,000 in stock-based compensation. On a non-GAAP basis, the adjusted net loss was $8.3 million, or $0.23 per share, and the adjusted EBITDA loss was $7.8 million.

The company said the FDA completed the current phase of its substantive review of GraftAssureDx in late July and requested additional information, which the company described as typical in such a process. GraftAssureDx, which the company claims was the first-ever kitted donor-derived cell-free DNA assay submitted for FDA authorization, runs on a digital PCR instrument made by Bio-Rad Laboratories (NYSE: BIO), an investor in iMDx.

Medicare's MolDX program issued a local coverage decision in July expanding reimbursement for donor-derived cell-free DNA surveillance testing, including doubling testing frequency in years two and three post-kidney transplant to four tests per year. MolDX also confirmed reimbursement coverage for treatment-response monitoring.

Research and development expenses fell 9% sequentially to $4.5 million, reflecting the wind-down of FDA submission activities. Sales and marketing expenses declined $486,000 sequentially to $1.9 million. Cash, cash equivalents, and restricted cash stood at $18.7 million at quarter end. Operating cash outflow was $9.3 million, and free cash outflow was approximately $10 million, partly due to working capital timing including annual bonus payments.

The information in this article is based on a press release statement from Insight Molecular Diagnostics Inc. GraftAssureDx has not been cleared or authorized for marketing by the FDA.

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