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IMDX Reports Second Quarter 2026 Results and Timely Progress on FDA Review of GraftAssureDx

IMDXBIO
  • FDA completed the current substantive review phase for GraftAssureDx in late July 2026 with timely feedback, leaving a clear set of remaining items for final authorization.
  • A favorable Medicare Local Coverage Decision issued in July 2026 expands reimbursement for dd-cfDNA surveillance testing, including doubling rates to four tests per year in the second & third years post-kidney transplant.
  • Medicare confirmed reimbursement coverage for treatment-response monitoring, allowing clinicians to use dd-cfDNA testing to guide anti-rejection drug therapy.
  • Strong head-to-head data published in Clinical Chemistry showed 99.2% agreement between GraftAssureDx & a leading NGS competitor, with superior analytical sensitivity.
  • The American Journal of Transplantation published results showing GraftAssure's Combination Model Score doubled positive predictive value to 81% while maintaining a 91% negative predictive value.
  • A multicenter study in Kidney International demonstrated GraftAssure's ability to monitor therapeutic efficacy for antibody-mediated rejection, reinforcing its role beyond biopsy rule-out testing.
  • Major U.S. reference labs are showing increased interest in adopting in-house dd-cfDNA testing due to reimbursement clarity & favorable clinical data.
  • Q2 2026 revenue was approximately $239,000, primarily from laboratory services, while research-use-only kit sales totaled $21,000.
  • Q2 2026 operating expenses were $11.6 million, with R&D expenses decreasing 9% sequentially to $4.5 million as FDA submission work streams concluded.
  • Q2 2026 net loss was $11.3 million ($0.31 per share), while non-GAAP net loss was $8.3 million ($0.23 per share).
  • Cash, cash equivalents, & restricted cash balance ended Q2 2026 at $18.7 million with outgoing free cash flow of approximately $10 million.
  • iMDx plans to host a virtual Key Opinion Leader event on August 17, 2026, to discuss in-house heart transplant rejection testing.
  • GraftAssureDx remains the company's primary focus as a kitted IVD product intended to enable local transplant center laboratories to run tests rather than relying on send-out services.