Insight Molecular Diagnostics Inc. Common Stock 2026 Q2 Earnings Call

Thanks, Gabby. It feels great to be coming to you today with line of sight on expected FDA marketing authorization for GraftAssureDx. We have three brief but promising takeaways today in our shareholder letter. The first is that after three years of rigorous kitted product development, we believe that we are seeing the light at the end of the tunnel on having a regulated product. Back in July, we got our additional information letter from the FDA. It is a normal part of the Class II process where they ask for some additional data and clarification on intended use as part of their review. Since submitting back in March, we have about tripled the amount of samples collected in the study and feel good about addressing all their questions and comments. Prior to submitting our next data package, we are going to have an SIR meeting with the FDA.

This meeting is a lot like the Q-Sub process where you get direct and written feedback on your planned approach. It is an opportunity for both parties to make sure there is clear understanding on what is needed to get through to authorization and clear up any potential misunderstandings. Once we have the green light from them, the next steps are pretty straightforward. We package it all up, hit submit, and wait for their response. Since March, we have been pleased with the timeliness of FDA's engagement. We continue to target receipt of FDA marketing authorization later this year, with the caveat that the timing of government agency review is not completely within our control. The second takeaway is that we can see that the market landscape is likely improving for transplant rejection tests like GraftAssureDx.

We believe that Medicare's recently expanded reimbursement guidelines for these tests even better primes GraftAssureDx for commercial success. We know our analysts are well familiar with the recent MolDX LCD, which boosts surveillance from eight to 14 tests in the first three years post-kidney transplant. This higher testing frequency is potentially great for our customers. It strengthens the economic case for bringing dd-cfDNA testing in-house. The market landscape is also improving on a competitive front. We believe that we are about two years ahead with regard to kitted product development among competitors. Third, and finally, we have seen strong head-to-head data that favorably compares our assay to other leading assays on the market, driving increased interest from potential future customers. That includes top transplant centers and reference labs here in the U.S.