Insight Molecular Diagnostics Inc. · NASDAQ:IMDX
Insight Molecular Diagnostics — Investor Presentation (August 2025)
15 slides from Insight Molecular Diagnostics's investor presentation, Aug 15, 2025
Slide 1: Virtual KOL Event to Discuss Insight Molecular Diagnostics' In-House dd-cfDNA Testing for Kidney Transplant Patients
Virtual KOL Event to Discuss Insight Molecular Diagnostics' In-House dd-cfDNA Testing for Kidney Transplant Patients NASDAQ:IMDX August 2025 iMDxinc.com
Slide 2: Agenda
Agenda Andrea James Introduction Chief Financial Officer, Insight Molecular Diagnostics Josh Riggs IMDX Kitted Strategy & GraftAssureDx Trial President & Chief Executive Officer, Insight Molecular Diagnostics Anthony Langone, MD dd-cfDNA Testing in Transplant Care Vanderbilt University Question and
Slide 3: Forward-Looking Statements
Forward-Looking Statements Safe-Harbor Statement This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on the Insight Molecular Diagnostics, Inc.’s (iMDx) management’s beliefs and assumptions and on information currently available to management.
Slide 4: Mission
Mission Democratize access to novel molecular diagnostic testing to improve patient outcomes 4 iMDxinc.com
Slide 5: U.S. transplant market
U.S. transplant market In the U.S., donor-derived cell free DNA (dd-cfDNA) Ripe for disruption testing is delivered via restrictive central lab service model. Two companies command ~90% market share1. About 250 kidney transplant centers nationwide. Highly concentrated Fewer than 100 generate ~80% of
Slide 6: Global partnership with Bio-Rad supports 'land & expand' strategy
Global partnership with Bio-Rad supports ‘land & expand’ strategy Laboratory Developed Research Use In Vitro Diagnostics Tests (LDT) Only Kit (RUO) Kit (IVD) (in development) Innovation center is Land Expand monetizable iMDxinc.com 6
Slide 7: GraftAssureDx FDA Trial: Validation of dd-cfDNA for Kidney Transplant Monitoring
GraftAssureDx FDA Trial: Validation of dd-cfDNA for Kidney Transplant Monitoring Goal of the study To see how effectively the test works at correctly assessing if a patient does or does not have organ rejection. We will validate the accuracy of GraftAssureDx compared to biopsy results with the goal
Slide 8: Primary Endpoint
Primary Endpoint Outcome Measure Measure Descriptions Relative percentage of dd-cfDNA levels of 0.5% and absolute values of 50cp/mL are considered to be the diagnostic cutoff for rejection, which will be refined during the pre-study phase. Clinical sensitivity of the dd-cfDNA test shall be better or
Slide 9: Introduction to Dr. Tony Langone
Introduction to Dr. Tony Langone Anthony Langone, MD is an Associate Professor of Medicine in the Division of Nephrology and Hypertension within the Department of Medicine at Vanderbilt University Medical Center. He received his undergraduate degree from Cornell University where he graduated with ho
Slide 10: Today's topics
Today’s topics Background of dd-cfDNA Clinical utility of dd-cfDNA: Current and future applications Benefits of bringing dd-cfDNA testing in-house iMDxinc.com 10
Slide 11: Background of dd-cfDNA
Background of dd-cfDNA What is dd-cfDNA? Biomarker detects donor organ DNA fragments in Clinical utility of dd-cfDNA: Current and future applications the blood - levels rise when the organ is injured Why is dd-cfDNA a preferred biomarker? Supported by peer-reviewed publications and Benefits of bring
Slide 12: Clinical utility of dd-cfDNA: Current and future applications
Background of dd-cfDNA Current Detects rejection earlier than standard monitoring; Clinical utility of dd-cfDNA: Current and future applications helps reduce number of biopsies Future Therapeutic efficacy monitoring (Anti-CD38 etc.), Benefits of bringing dd-cfDNA testing in-house and more iMDxinc.co
Slide 13: Benefits of bringing dd-cfDNA testing in-house
Background of dd-cfDNA Local lab access cuts turnaround from 5 to 7 days to within same day, improving decision-making speed enabling fast Clinical utility of dd-cfDNA: Current and future applications therapeutic interventions Expands reach into greater than 400 U.S Benefits of bringing dd-cfDNA tes
Slide 14: Q&A
Q&A NASDAQ:IMDX August 2025 iMDxinc.com
Slide 15: Thank you!
Thank you! NASDAQ:IMDX August 2025 iMDxinc.com
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