Insight Molecular Diagnostics Inc. Q4 FY2025 earnings call

Welcome to the call discussing Inside Molecular Diagnostics' fourth quarter 2025 results. Josh Riggs mentions they've submitted Graft Assured DX to the FDA for review. The company's focus is shifting to product launch and commercialization. They have a registry with 28 centers starting to become trial sites. There's head-to-head data from a top transplant center showing equivalent results to national reference labs. 2026 goals include expanding market access, commencing Graph-Assured research-use-only, marketing Graft Assure Core, submitting to UK and EU, and pivoting R&D to heart transplant testing. Andrea James talks about commercializing the kidney transplant assay, controlled investments, maintenance and growth spending, low revenue on lab services this year, introduction of non-GAAP EPS and adjusted EBITDA tables, and intangible asset write-down related to oncology assets.

Intend to commercialize and scale the kidney transplant assay, maintain product development momentum for heart transplant testing, have 90-day right-at-first negotiation with BioRad post-FDA authorization, expect low lab services revenue this year with almost no revenue in Q1, plan to have updates on centers engaging when reporting Q1

Q: Thomas Flatton asked about participation in the registry study in terms of revenue and agreement with BioRad on commercial rights.

A: Company will sponsor registry work, with 90-day right-at-first negotiation post-FDA authorization with BioRad.

Q: Mike Mattson asked about next steps in heart application, heart vs liver choice, and benefit of patient management shift.

A: For heart, working with centers for smaller study, 510k pathway is faster, demand for heart testing is higher, benefit is test's suitability and potential increase in tests per patient due to earlier detection.

Q: Ben Mee asked about billing and coding once authorized and internal validation studies.

A: Submitting for Z code, bridging reimbursement, and reference to presentation at Seattle for center feedback on bringing technology in-house