Insight Molecular Diagnostics demonstrated significant progress in their Q3 2025 performance, highlighting advancements in their GraftAssure DX assay and preparing for an anticipated strong market introduction in 2026.

• Successfully optimized GraftAssure DX’s test workflow from two steps to one, enhancing turnaround time and ease of use for transplant centers.
• Positive feedback and data from pilot studies at multiple sites indicate high confidence in assay performance ahead of the upcoming FDA submission.
• A growing interest in in-house testing from transplant centers drives demand, supported by a new registry program aimed at collecting real-world data on the assay’s performance.
• Statistical equivalence demonstrated against legacy tests reinforces GraftAssure’s competitive position, enabling easier transitions for clinicians.
• First reports using the anticipated Centimeters score are expected in 2026, with early access for registry participants, fostering early adoption.