iMDx says FDA sought more data on GraftAssureDx, gives itself 180 days to answer
The company disclosed an FDA Additional Information Request tied to its transplant test kit and reported a Q2 2026 net loss of $11.3 million.
Insight Molecular Diagnostics (Nasdaq: IMDX) disclosed on August 10, 2026 that it had received an Additional Information Request from the FDA regarding its submission for GraftAssureDx, and that it must respond in full within 180 days1. The company said it considers the request a normal step in the FDA review process and says it is ready to submit its answer1. It also said it expects one more meeting with the FDA before the fourth quarter of this year1.
In its shareholder letter, iMDx described the review status further, saying the FDA finished the current stage of its substantive review of GraftAssureDx in late July, in a timely manner, and asked the company for more information, which it called typical for this kind of regulatory process1.
On reimbursement, the company said Medicare contractor MolDX issued a favorable local coverage decision that broadens the reimbursement rules for dd-cfDNA testing, allowing more frequent surveillance testing than a prior draft policy, including twice as many tests per year in years two and three after a kidney transplant, up to four annually1.
Financially, Q2 2026 revenue was about $239,000, gross profit was $157,000 for a 65.7% gross margin, and net loss was $11.3 million, or $0.31 per share1. Cash, cash equivalents, and restricted cash totaled $18.7 million at quarter end.1 The company reiterated that it remains essentially "pre-revenue" for its diagnostic kit business while awaiting possible FDA authorization1.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.