Insight Molecular Diagnostics : Investor Deck (imdx investor presentation may 2026)

Published: 2026-05-13 16:33:46 ET IMDX

Published on 05/13/2026 at 04:33 pm EDT

NASDAQ:IMDX

May 2026

iMDxinc.com

MISSIO N

Decentralize access to novel molecular diagnostic testing to improve patient outcomes

iMDxinc.com

Experienced Leadership

Pioneering Molecular Diagnostics & Disruptive Growth

Josh Riggs

President & Chief Executive Officer

Ekkehard Schütz, MD, PHD, FADLM

Chief Science Officer

Yuh-Min (Johnson) Chiang, PHD

Chief Technology

Officer

Andrea James

Chief Financial Officer

iMDx

Investment Summary

Disruptive approach to molecular diagnostic testing: Empower local labs to test in-house with kits, versus sending out to central labs

Proven credibility in first strategic market: Kidney transplant(1)

Go-to-market strategic partner and investor, Bio-Rad Laboratories

Science-driven team, experienced in molecular diagnostics and managing rapid growth

Full R&D pipeline to fuel portfolio expansion over the next decade

IP portfolio attractive to partners and enables value protection

(1) See appendix slides 33, 34 and 35

Kitted:

Designing a lab test for a box

iMDx CTO Johnson Chiang holds up GraftAssureIQ kitted test

iMDxinc.com 8

Building a kitted product engine

Strong Reimbursement

IP Protected

iMDxinc.com

Transplant

Full R&D pipeline to fuel decade of growth

Oncology

The rest of the presentation will foc1u0s on transplant, our near-term priority

splant

Tran

iMDxinc.com

$2B+ greenfield global opportunity

Source:

2024 GODT data supports 128,990 global annual transplants (110,467 for kidney, 10,287 for heart, and 8,236 for lung transplants.) Median graft survival rate of 11.7 years for kidney per SRTR, 11.9 years for heart per ISHLT,

6.2 years for lung per ISHLT. Surveillance testing frequency per MolDx LCD Draft of 4-2 for kidney, 12-2 for heart, and 12-2 for lung. Management estimated per-test value benchmarked to ~25% of expected reimbursement rate; actual pricing may vary.

Key:

TAM - Total Addressable Market

GODT - Global Observatory on Donation and Transplantation

ISHLT - The International Society for Heart & Lung Transplantation SRTR - Scientific Registry of Transplant Recipients

MolDx - MolDx is a program run by Medicare to help decide which genetic and molecular tests they will pay for and under what conditions.

LCD - Local Coverage Determination

"High-quality, standardized

generating multicenter studies to establish the appropriate context of

use for this promising assay."

- January 2026 conclusion by the American Society of Transplantation (AST) and the American Society for Histocompatibility and Immunogenetics (ASHI) STAR working group in the American

Journal of Transplantation

Strong Reimbursement

U.S. Medicare reimbursement listing of $2,753 per result based on MolDx Test Registry pricing for GraftAssureCore

- per CPT code 81479 and DEX Z-code Z0507

(https://app.dexzcodes.com)

IP Protected

GraftAssureDx … planned for 2026

CMS - Center for Medicaid Services LDT - Lab Developed Test

RUO - Research Use Only

FDA - US Food and Drug Administration IVD - In Vitro Diagnostic

US LDT Validation, 2022

Medicare (CMS) Reimbursement, 2023 major milestone

Beck et al. ddPCR for Tx Injury, Clinical Chemistry 59:12 1732-1741

(2013)

Oellerich et al. Kidney Validation Cohort 2019 AJT

U.S. Patent No. 11,155,872

How we win: Deliver what decision makers want

Transplant Physicians

Control

Fast turnaround times

Ability to conduct their own research

Lab Directors

In-house testing

Simple workflow

Full data access

Hospital Administrators

Revenue generation opportunities

Research-forward reputation

ABO Blood Typing HLA Typing

PRA / DSA Screen Crossmatch (CDC/Flow) Infectious Disease NAT

surgery

The transplant category has already adopted in-house molecular testing for organ matching

Year 1+

Month 1-6

Day 1-7

Pre-Op

Long-Term Ongoing

Immediate Post-Op Intermediate

Matching

Therapeutic Drug Monitoring (TDM) Graft Markers (Kidney)

Graft Markers (Liver)

Graft Markers (Heart/Lung) Hematology (CBC)

Transplant hospitals already perform most tests in house. Our kits are a natural fit.

dd-cfDNA (Liquid Biopsy)

Viral Load PCR

Organ Biopsy

Metabolic Panel

DSA Screen Renal Function

dd-cfDNA (Liquid Biopsy)

iMDx in the transplant patient care diagnostic value chain

Key:

ABO - blood typing system based on A and B red blood cell antigens; HLA - human leukocyte antigen; PRA - panel reactive antibody; DSA - donor-specific antibody; CDC - complement-dependent cytotoxicity; NAT - nucleic acid testing; TDM - therapeutic drug monitoring; CBC - complete blood count; PCR - polymerase chain reaction; dd-cfDNA - donor-derived cell-free DNA.

Bio-Rad (NYSE: BIO) is a top five shareholder and has made four equity investments in iMDx

Our test runs on the Bio-Rad platform

Coordinated rapid development of test kits

Opportunity for partnership expansion, milestone-based investments

We are not building this alone.

iMDxinc.com 19

iMDx + Bio-Rad

Demonstrating clinical utility of digital PCR

Opening academic hospital core and HLA labs to Bio-Rad platform

2026: Expect to receive FDA clearance for GraftAssureDx (kidney) for the QX600Dx

Goal of showcasing the digital PCR advantage in heart transplant management

iMDx product development team members receiving a Bio-Rad QX600Dx ddPCR System (IUO), upon which the GraftAssureDx assay is performed.

GraftAssure Deployments

Transplant Center Laboratory Customer

Location

RUO

Pilot

FDA

Trial

Thomas Jefferson University

Pennsylvania, US

University Hospital Lab

Singapore

Large Hospital Lab

Switzerland

The Charité, Humboldt University of Berlin

Berlin, Germany

University Hospital Lab

Austria

University Hospital Lab

Heidelburg University Hospital

Heidelberg, Germany

Tampa General Hospital

Tampa, Florida

University Hospital Lab

Texas

Baylor Scott & White Health

Dallas, Texas

Mayo Clinic in Florida

Jacksonville, Florida

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania

Cleveland Clinic

Cleveland, Ohio

Intermountain Medical Center

Murray, Utah

Vanderbilt University Medical Center

Nashville, Tennessee

Major transplant hospital laboratory

Czech Republic

Transplant Hospital Lab

France

University of Southern Calif. Keck School of Medicine

Los Angeles, California

University Lab

British Columbia, Canada

Ivy League University Lab

Northeast, US

University Hospital Lab

Mountain West, US

22 Sites

9 Countries

3 Continents

Institutes planning to publish multiple abstracts in 2026

Third party head-to-head data emerging that is favorable to iMDx

Many names redacted for competitive sensitivity

RUO = Research Use Only

After FDA submission for GraftAssureDx (kidney) in March 2026 Goal of expanding rapidly into heart transplant testing

$105 million estimated TAM in the United States

$240 million estimated TAM globally

Significance of cfDNA results of heart will increase site adoption

Higher testing frequency per patient

Higher clinical stakes

Further adoption incentive for hospitals

Rapid development: GraftAssure is designed to be organ-agnostic

Target 2027 heart kit sales

Sources:

2024 GODT data supports 10,287 global annual heart transplants. 2025 OPTN data supports 4,587 annual heart transplants in the United States. Median heart graft survival of 11.9 years per ISHLT. Surveillance testing frequency per MolDx LCD Draft of 12-2 for heart. Management estimated per-test value benchmarked to ~25% of expected reimbursement rate; actual pricing may vary.

Moeller et al., Significance of Elevated Donor-Derived Cell-Free DNA in Heart Transplant Recipients With Negative Endomyocardial Biopsies: A Dawn of a New Era, AHA/ASA Journals, Circulation: Heart Failure, Volume 18, Number 11.

Heart: The Digital PCR Advantage

Analytical Performance

0.25%

0.20%

0.15%

Threshold for acute rejection in heart recipients (5)

0.10%

0.05%

0.00%

References

Limit of Blank Lower Limit of Detectio n Lower Limit of Quantification

Prospera(1)

Allosure(2 )

Devysr (3)

Alloseq (4)

Competitor

Competitor Competitor Competitor

Lower is better because you can pick up signal before there is a problem

Yücel Altuğ, PhD, Analytical Validation of a Single-nucleotide, Polymorphism-based Donor-derived Cell-free DNA Assay for Detecting Rejection in Kidney Transplant Patients. Transplantation 2019 Vol 103 No: 12. doi: 10.1097/TP.0000000000002665

Wong L,The Evolution and Innovation of Donor-Derived Cell-Free DNA Testing in Transplantation J Med Diagn Meth, 2020 Vol. 9 Iss.5. doi: 10.35248/2168-9784.2020.9.302

Daniels L. et al. Performance assessment of the One Lambda Devyser Accept cfDNA assay in lung transplantation. 50th ASHI Annual Meeting, Anaheim, CA October 21-25 2024 (P605)

Casas S et al. Multi-centre analytical performance verification of an IVD assay to quantify donor-derived cell-free DNA in solid organ transplant recipients HLA. 2024;103:e15518. doi: 10.1111/tan.15518

(5) Rodgers N et a. Comparison of two donor-derived cell-free DNA tests and a blood gene-expression profile test in heart transplantation. Clin Transplant 2023 37(6): e14984. doi: 10.1111/ctr.14984.

IP attractive to industry partners

Multiple strategic partnership opportunities

IP Category

Products

Product Partner

Service Lab Partner

Organ Transplant

Bio-Rad signed Q2 2024, potential for expansion

National reference lab signed Q1 2026, potential for expansion

Oncology Therapy Selection

Development letter of intent with major instrument maker signed Q2 2025

Oncology Therapy Monitoring

Compelling business model

High-value creation

Empowers doctors to reduce uncertainty to make better decisions to save lives. Enables researchers to measure biomarkers to inspire innovation.

High-value capture

Intellectual property protects our market position, commands high reimbursement rates, and therefore, may lead to high margins and profitability.

High-quality recurring revenue

Once a standard of care is proven or adopted, customer lifetime value often exceeds 30 years.

A pure play on major industry tailwinds

Precision medicine

Genomics innovation enables personalized medicine.

Localized care

Diagnostics trend toward the patient.

Decentralized healthcare means the market trends toward point-of-care testing.

Rapid care

Liquid biopsy is less invasive. Digital PCR is simple, fast, and easy to use.

iMDx Investment Summary Recap

Disruptive approach to molecular diagnostic testing

Empower local labs with kits

Stronger business model

Proven, more affordable, faster tests

Proven credibility in first strategic market: Kidney transplant

U.S. Medicare (CMS) reimbursement for GraftAssureCore received 2023, boosted 2025

New England Journal of Medicine

(NEJM) study published May 2024

Go-to-market strategic partner and equity investor

Industry leader Bio-Rad Laboratories, Inc. (NYSE:BIO) signed in Q2 2024

Opportunities for future milestone-based investments

Science-driven team, experienced in molecular diagnostics and rapid growth

Full R&D pipeline to fuel growth and portfolio expansion over the next decade

IP portfolio protects market position and is attractive to potential partners

Insight Molecular Diagnostics

Disclaimer

Insight Molecular Diagnostics Inc. published this content on May 13, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 13, 2026 at 20:30 UTC.