Insight Molecular Diagnostics (IMDX) H.C. Wainwright 27th Annual Global Investment Conference summary

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.

• Strategy centers on moving testing closer to patients at transplant centers, enabling local revenue retention and improved patient management.

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

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

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

Product development and regulatory progress

• Test has a decade-long history of clinical validation and is well reimbursed, with recent rates increasing to $2,753.

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

• Registry established to collect advanced data, including the Berlin protocol for high-risk patients and improved positive predictive value (up to 80%).

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

• Clinicaltrials.gov listing and KOL engagement with leading investigators enhance credibility.

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 relative to reimbursement, enabling software-like margins and scalable global expansion.

• Oncology pipeline includes DetermaCNI and DetermaIO, with recent patent approval in colorectal cancer and a strategic LOI for PD-L1 classification, but current focus remains on transplant.

• Future investments in oncology expected as transplant cash flow builds.