Insight Molecular Diagnostics (IMDX) investor relations material

Market opportunity and strategy

• Focus on transplant monitoring, a $2 billion U.S. clinical market, identified as underpenetrated and ripe for disruption due to inefficiencies and centralization at a few labs.

• Plan to decentralize testing by enabling transplant centers to perform tests locally, capturing revenue and improving patient management.

• Patent-protected workflow and high reimbursement rates create barriers to entry and attractive margins.

• Global greenfield opportunity estimated at $1 billion for regulated transplant testing, with recurring revenue from frequent patient monitoring.

• Partnerships with three of the top 10 U.S. transplant centers and Bio-Rad Laboratories support rapid market entry and adoption.

Product development and regulatory progress

• Test is well-validated with over a decade of published research and cited in key reimbursement decisions.

• Achieved $2,753 reimbursement per test and improved rates from Multi-X.

• First patient enrolled in pivotal study; FDA submission expected by end of year, with potential approval and launch by mid-next year.

• Head-to-head data shows equivalence with top competitors, supporting clinical adoption.

• Registry and clinicaltrials.gov listing established to support data collection and payer engagement.

Financial outlook and partnerships

• Bio-Rad Laboratories has made multiple equity investments and is closely aligned in regulatory and commercialization efforts.

• Registry program may enable earlier-than-expected revenue next year, though no formal guidance provided.

• Test manufacturing costs are low, enabling software-like margins and scalable global expansion.

• Oncology pipeline includes DetermaCNI and DetermaIO, with current focus on research and potential future investment as cash flow grows.