Insight Molecular Diagnostics (IMDX) Investor presentation summary

Mission and strategy

• Aims to decentralize access to novel molecular diagnostic testing, improving patient outcomes by empowering local labs to perform in-house testing with kits rather than relying on central labs.

• Focuses on a disruptive approach with a science-driven team and a robust R&D pipeline for portfolio expansion over the next decade.

• Strategic partnership and equity investment with Bio-Rad Laboratories, enabling rapid kit development and platform integration.

• Proven credibility in the kidney transplant market, with plans to expand into heart transplant testing.

• IP portfolio is attractive to partners and protects market position.

Market opportunity and clinical demand

• Regulated transplant testing represents a $2B+ global opportunity, with high clinical demand for decentralized, standardized dd-cfDNA testing.

• U.S. Medicare reimbursement for GraftAssureCore is $2,753 per result, supporting strong revenue potential.

• Customers, including lab directors and hospital administrators, seek in-house, fast, and actionable testing solutions.

• Transplant hospitals already perform most tests in-house, making the kits a natural fit in the diagnostic workflow.

Product portfolio and innovation

• GraftAssureDx is the flagship product, with RUO kits launched in 2024 and revenue beginning in Q2 2025; FDA IVD submission planned for March 2026.

• Product engine is built on high clinical demand, strong reimbursement, and IP protection.

• GraftAssure is designed to be organ-agnostic, targeting rapid expansion into heart transplant testing by 2027.

• Analytical performance of digital PCR offers lower detection limits compared to competitors, enhancing clinical utility in heart transplant management.