Delivering the speed and precision of digital PCR to dd-cfDNA testing for transplant patients when answers matter most.

OVERVIEW

Your Digital-PCR Partner In Transplant Care

GraftAssureCore™ leverages advanced digital PCR (dPCR) technology to deliver highly quantitative, reliable donor-derived cell-free (dd-cfDNA) results for transplant monitoring. With rapid turnaround and precise, data-driven insights across various clinical scenarios, GraftAssureCore empowers clinicians to make timely, informed decisions, promoting better patient outcomes and enhanced confidence in post-transplant care.

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Precision Technology For Individualized Patient Care

GraftAssureCore is a CLIA-certified, laboratory developed test that quantifies dd-cfDNA to help detect early signs of organ rejection. Powered by precision molecular technology, it delivers reliable, actionable insights to support individualized patient management in real time.

Streamlined Process For Easy Implementation

Step 1

Post-transplant patient blood sample drawn at transplant facility or local laboratory

Step 2

Send samples to iMDx CAP/CLIA certified laboratory

Step 3

dd-cfDNA measured using dPCR

Step 4

Risk for active rejection reported

PRODUCT HIGHLIGHTS

Why GraftAssureCore

For Fast and Informed Decisions in Transplant Care

Enhanced Clinical Confidence

  • GraftAssureCore has a high NPV of 94% for ABMR in kidney transplant patients, providing clinicians and patients with a clear and reliable assessment of graft health1,2
  • Validated in >1100 kidney, liver and heart transplant recipients, ensuring GraftAssureCore provides results you can trust.1-14

Rapid Turnaround Time

  • GraftAssureCore has one of the fastest turnaround times clinically available in dd-cfDNA testing, typically delivering results within one to two days.
  • Our dPCR technology is designed to eliminate the need for batching, which streamlines the workflow and empowers clinicians with timely, actionable results that support early interventions and improved patient outcomes.

Biopsy-Sparing Protocols

  • GraftAssureCore’s precise dd-cfDNA measurements help avoid unnecessary biopsies, minimizing patient burden and lowering healthcare costs. With exceptional specificity and negative predictive value, GraftAssureCore is a reliable tool to guide clinical decisions and reduce dependence on invasive procedures.1-3

Affordable Testing Solution

  • GraftAssureCore is covered by Medicare for kidney transplant patients to support low-cost care, which enables access to high-quality, precision testing without sacrificing care standards.

Comprehensive and Quantitative Reporting

  • GraftAssureCore provides both dd-cfDNA as copies per milliliter plasma (cp/mL) and as a percentage (%), offering a comprehensive view of graft health.
  • This dual reporting helps to clarify the impact of fluctuating cfDNA levels from the recipient, making it easier for clinicians to interpret results with confidence.

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May guide dosage decisions in immuno-suppressive therapy to maintain adequate immunosuppression10

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Rejection may be detected before clinically suspected damage8

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Accelerated turnaround time

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Allows for early and real-time intervention

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Avoids unnecessary invasive biopsies

See Our Clinical Evidence

Why GraftAssureCore

Transforming Diagnostics. Empowering Care.

Validation Data

GraftAssureCore Identifies Biopsy-Proven Rejection: GraftAssureCore has been shown to significantly discriminate between rejection and non-rejection using biopsy-proven samples.1,2

Trusted Science

GraftAssureCore Identifies Biopsy-Proven Rejection: GraftAssureCore has been shown to significantly discriminate between rejection and non-rejection using biopsy-proven samples.1,2

Driving Innovation

  • Through collaboration with research partners, we innovate dd-cfDNA applications to improve transplant outcomes, driven by groundbreaking research.
  • Clinical Utility For De Novo DSA-Positive Patient Surveillance: GraftAssureCore detects ABMR up to 10 months earlier than traditional protocols (p<0.001). For DSA+ patients, time to diagnosis was significantly reduced (3.6 ± 3.0 vs. 14.1 ± 1.9 months, p<0.001), showcasing the effectiveness of longitudinal monitoring.7
  • GraftAssureCore Paving The Way For Anti-Rejection Therapy Monitoring: GraftAssureCore demonstrated robust clinical utility in monitoring treatment efficacy of the novel anti-CD38 antibodies targeting antibody-mediated rejection (ABMR) in a case/control phase II study on felzartamab published in the New England Journal of Medicine, and in a series of cases treated off-label with daratumumab.5,6

Robust Technology

GraftAssureCore’s technology leverages carefully selected single nucleotide polymorphisms (SNPs) with high minor allele frequencies across diverse global populations, maximizing the availability of genetic information for precise dd-cfDNA quantification. By utilizing optimized dPCR technology, fewer SNPs are needed to achieve highly accurate and quantitative results.

This allows providers to safely and effectively monitor their kidney transplant patients.

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Validation Data

  • Statistically significant discrimination between stable patients and those with acute rejection proven in two independent studies. 8,9
  • 31 samples taken from 17 patients during biopsy-proven rejection episodes8
  • The percentage of dd-cfDNA was elevated substantially (median 29.6%) compared with that in 282 samples from 88 patients during stable periods (median 3.3%; p<0.001)8
  • Elevated dd-cfDNA was seen 8-15 days prior to rejection confirmed by biopsy and before LFTs showed evidence of rejection during the same timepoint in five cases of rejection 8
  • In a multivariable logistic regression analysis, no combination of LFTs had an equal or better diagnostic value than dd-cfDNA 8

Assess Rejection

  • GraftAssureCore has a 96.5% area under the receiver operating characteristic curve (AUCROC)8
  • All graft-derived cell-free DNA percentage values were considered (282 samples from stable periods and 31 samples during biopsy-proven acute rejection)8

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Guide Immunosuppression

  • In a clinical study of 103 samples, there was a highly significant segregation towards patients with elevated dd-cfDNA (>10%) and tacrolimus blood concentrations below the target concentration of 8-12mg/L 10
  • GraftAssureCore may be used to optimize immunosuppressive drug dosing for patients who have recently had a treatment change

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Provider Resources

KIDNEY CLINICAL SUMMARY

Mayer KA, et al. (2024)

A Randomized Phase 2 Trial of Felzartamab in Antibody-Mediated Rejection. NEJM DOI: 10.1056/NEJMoa2400763.

KIDNEY CLINICAL SUMMARY

Akifova A, et al. (2023)

Donor-Derived Cell-Free DNA in Biopsy-Proven Antibody-Mediated Rejection Versus Recurrent IgA Nephropathy After Kidney Transplantation. Kidney International Reports. Vol. 8, Issue 10, P2141-2145.

KIDNEY CLINICAL SUMMARY

Oellerich M, et al. (2019)

Absolute quantification of donor-derived cell-free DNA as a marker of rejection and graft injury in kidney transplantation: Results from a prospective observational study. Am J Transplant 19(11):3087.

KIDNEY CLINICAL SUMMARY

Schütz E, et al. (2020)

Time-dependent apparent increase in dd-cfDNA percentage in clinically stable patients between one and five years following kidney transplantation. Clin Chem 66(10):1290.

LIVER CLINICAL SUMMARY

Oellerich M, et al. (2014)

Use of graft-derived cell-Free DNA as an organ integrity biomarker to reexamine effective tacrolimus trough concentrations after liver transplantation. Ther Drug Monit 36(2):136.

LIVER CLINICAL SUMMARY

Schütz E, et al. (2017)

Graft-derived cell-free DNA, a noninvasive early rejection and graft damage marker in liver transplantation: A prospective, observational, multicenter cohort study. PLoS Med 14(4):e1002286.

Patient Resources

KIDNEY INFORMATION SHEET

Intro to VitaGraft Kidney

For nephrologists, surgeons and clinical transplant professionals.

GraftAssureCore

GraftAssureCore Patient Guide

For patients and caregivers seeking more information on GraftAssureCore, how it may help, and where it fits into post-kidney transplant care.

GraftAssureCore

GraftAssureCore Patient Billing Brochure

For information on insurance coverage for GraftAssureCore.

KIDNEY INFORMATION SHEET

VitaGraft Kidney Patient Billing Brochure - Spanish (Guía de Facturación Para Pacientes)

Para obtener información sobre la cobertura del seguro para VitaGraft Kidney.

LIVER INFORMATION SHEET

Intro to VitaGraft Liver

For hepatologists, surgeons, and clinical transplant professionals.

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Frequently Asked Questions

Who can I contact with questions?
  • iMDx Main Phone: 949-409-7600
  • Customer Experience Information:
  • CAP/CLIA-Certified Laboratory in Nashville, TN:
    • Monday – Friday: 6:30am CST – 12am CST
    • Saturday: 8am CST – 6pm CST
  • Customer Experience Team:
    • 8am EST – 5pm EST
  • GraftAssureCore is a blood-based transplant monitoring test that quantifies the concentration of donor-derived cell-free DNA (dd-cfDNA) following liver and kidney transplantation.
  • Increased amounts of dd-cfDNA following transplantation may indicate organ damage and possible rejection.
  • GraftAssureCore is not indicated in patients who are: pregnant, less than two weeks post-transplant for
    subsequent testing, recipients of an allograft from an identical twin, bone marrow transplant recipients,
    recipients of an allogeneic stem cell transplant, recipients of a non-liver or non-kidney organ transplant,
    or recipients of multiple organ transplants.

Blood samples must be processed within 7 days of collection.

Less than 48 hours within specified hours of operation.

Through the online portal or by filling out a paper Test Requisition Form (TRF). Please contact your Local Representative or iMDx Customer Experience (844-621-8880) for any questions.

  • Patients can make a payment by check or credit card (accepted types: VISA, Mastercard, and Discover). We accept credit card payments over the phone. We send statements with the mailing address and phone numbers to the patient every 30 days for 3 cycles.
  • We’re here to help iMDx Customer Service can answer any questions you have.

    Please contact us at:
    phone: 844-621-8880
    [email protected]

    We do not want cost to be a barrier for testing, patients can call (844-621-8880) or fax (844-584-3467) to see if they qualify for our financial assistance program.

An EOB is a statement from your health insurance plan describing what costs it will cover for medical care or products you’ve received. It is not a bill.

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GraftAssureCore™ today!

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iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.

James Liu

James Liu joined iMDx in July 2021 and was appointed Vice President of Accounting, Controller, Treasurer, and Principal Accounting Officer in March 2025.  He has held several key roles at iMDx, including Senior Director, Controller & Principal Accounting Officer and Manager of SEC Reporting & Compliance.  James also served as interim Principal Financial Officer from August 2023 to June 2024, overseeing financial operations and public company reporting.

Before iMDx, James served as Accounting Manager at Acacia Research Corporation, where he led the SEC reporting and compliance, accounting close, and all other financial reporting requirements of an opportunistic capital platform that identifies and acquires other. He also worked as Senior Accountant at Gatekeeper Systems, Inc. and as Senior Assurance Associate at BDO USA, LLP, gaining deep expertise in financial reporting and assurance practices across multiple industries.

James holds a BASc degree from the University of California, San Diego, and is a Certified Public Accountant.

Peter Hong

Peter Hong oversees iMDx’s legal department. Before joining iMDx in August 2021, Peter was an associate at Stradling Yocca Carlson & Rauth, P.C., where he represented both public and private companies in capital markets, M&A, and corporate governance matters. Prior to that, he worked at the New York office of Covington & Burling LLP, where he represented underwriters in the initial public offerings and follow-on offerings of biotechnology companies.  At Covington, Peter also advised overseas clients with regard to restructuring, employment matters and the formation of U.S. subsidiaries.

Peter earned his JD from Columbia Law School and his Bachelor of Science in Business Administration from Washington University in St. Louis. He is admitted to practice law in New York and California.

Ryan Andrews

Ryan Andrews joined iMDx in 2019 and currently serves as Vice President of Commercial, leading the strategic commercialization of iMDx’s innovative products and solutions. Prior to this role, he held key leadership positions within the company, including Director and Senior Director of Marketing, where he played a pivotal role in shaping iMDx’s market strategy and brand presence.

With extensive experience in the diagnostics and life sciences industry, Ryan brings a deep understanding of market dynamics, business development, and commercial execution. His expertise spans product commercialization, strategic partnerships, and market expansion, ensuring iMDx’s solutions reach the healthcare providers and patients who need them most.

Before joining iMDx, Ryan was a Principal at Bethesda Group, LLC, a boutique consulting firm specializing in guiding small and mid-stage diagnostic companies and investment groups through market entry, product launches, and commercialization strategies. He has also held sales, marketing, and operational leadership roles at Thermo Fisher Scientific, Life Technologies, and Cytovance Biologics, where he gained extensive experience in the biotechnology, diagnostics, and life sciences sectors.

Ryan holds an MBA from the University of Mississippi and remains committed to advancing precision diagnostics and improving patient outcomes through innovative commercial strategies.

Sandra O’Donald

Sandra is an activator and results-driven leader with expertise in operational leadership, commercialization, and corporate integration. With a strong record of driving transformation across small and mid-sized organizations, Sandra brings a unique ability to align cross-functional teams, streamline operations, and deliver measurable business outcomes.

Sandra joined iMDx in December 2019, and in her current role, she leads business operations in support of product development, working closely with senior leadership to ensure alignment with the company’s long-term strategic goals. She champions scalable processes, fosters continuous improvement, and supports innovation throughout the organization.

Beyond her corporate responsibilities, Sandra serves as Vice President of the Orange County chapter of the Healthcare Businesswomen’s Association (HBA), where she partners with the board to shape the chapter’s vision, drive strategic initiatives, and engage with the Chapter Advisory Board to elevate leadership and inclusion in the healthcare industry.

Sandra is known for driving consensus among teams, focused execution of goals and turning strategy into action.

Sandra earned a Bachelor of Business Administration (B.B.A.) and HR Management Certification from California State University, Fullerton.

Andrea James

Andrea James is an expert in guiding financial strategy through multiple phases of growth, raising and stewarding capital, and building relationships with high quality institutional investors.  Prior to joining iMDx in 2024, she served in a series of escalating roles at Axon Enterprise, Inc. (Nasdaq: AXON), including Chief Communications Officer and Head of Investor Relations, and Senior Vice President of Strategy. She played a key role in the company’s growth from a $1 billion to a $20 billion market capitalization and established Axon’s corporate strategy function, overseeing capital stewardship, mergers and acquisitions, strategic partnerships, and investments. Her leadership contributed to more than $550 million in equity capital offerings.

 Before joining Axon, Andrea assisted Tesla, Inc. (Nasdaq: TSLA) with strategic investor relations, and has also served as Vice President and Senior Research Analyst at Dougherty & Co. (now Colliers Securities), specializing in researching disruptive technologies.

Andrea holds a Bachelor of Science, summa cum laude, in Computer Information Systems from American University. She also earned a Master of Science in Journalism from Northwestern University, graduating with Kappa Tau Alpha honors.

Yuh-Min (Johnson) Chiang, PhD

Johnson Chiang is an experienced technology leader with a strong background in molecular diagnostics, focusing on product development, systems integration, and regulatory strategy. Johnson joined iMDx in 2021, having previously served as Chief Technology Officer at Alveo Technologies, an IVD company that specializes in developing cutting-edge molecular diagnostic tests. At iMDx, he continues to leverage his expertise to drive innovation in diagnostic solutions.

Previously, Johnson led the development of the be.well COVID-19 Test at Alveo Technologies, which completed a U.S. clinical trial and earned the CE mark and UK approval. In addition to his leadership in product development, he was involved in fundraising efforts that raised $50MM over four years and played a key role in securing the XPrize Grand Award for Rapid COVID Testing. Earlier in his career, Johnson was the Head of Systems Integration & Molecular Biology at Foundation Medicine, Inc., and held senior management roles at Life Technologies and Thermo Fisher Scientific. One of his key achievements was leading the Oncomine Dx Target Test, the first NGS-based CDx test approved by the FDA. Additionally, he holds several patents and has published numerous papers in biotechnology.

Johnson holds a Ph.D. in BioMEMS (Micro Electro-Mechanical Systems) from the University of California, Irvine. He also earned a Master of Engineering from The Ohio State University.

Prof. Dr. Ekkehard Schütz, MD, PhD, FAACC

Ekkehard (Ekke) Schütz is a renowned leading expert in molecular genetics, diagnostics, and cell-free DNA (cf-DNA) research. He joined iMDx in April 2021 through its acquisition of Chronix Biomedical Inc. and now serves as Managing Director of Chronix Biomedical GmbH (a fully owned subsidiary of iMDx) and Chief Medical Officer (CMO) for Europe.

Under his leadership, Chronix became a leader in cf-DNA diagnostics, producing numerous publications and securing a broad patent portfolio, including ten patent families with many issued patents in the U.S. and Europe, which he invented.

Fellow of the National Academy for Clinical Biochemistry (now FAACC) since 2014, Ekke has published over 190 peer-reviewed papers, contributed to 100+ congress abstracts, and received several international scientific awards. He has also been a reviewer for top scientific journals, including PNAS, Clinical Chemistry, Clinical Biochemistry, and Nucleic Acids Research.

Ekke trained in laboratory medicine at Georg-August-University Hospital in Goettingen, Germany under Prof. Dr. Michael Oellerich, a renowned expert in therapeutic drug monitoring and transplantation surveillance.

Josh Riggs

Josh Riggs is an accomplished and results-driven business leader with extensive experience in market access, molecular diagnostics, and strategic business development. He joined iMDx in August 2020, where he quickly became a key driver of the company’s growth and innovation. Initially serving as Senior Director of Business Development and General Manager of Transplant, Josh demonstrated exceptional leadership and business acumen, which ultimately led to his appointment as CEO in December 2022. As CEO, Josh has spearheaded the strategic pivot of iMDx, leading the organization to decentralize its testing approach and expand its impact on patient care.

Prior to his tenure at iMDx, Josh founded and led Intelliger Consulting, a firm specializing in healthcare marketing strategies. He also served as a principal at Bethesda Group, LLC, where he advised diagnostic companies and investors on market entry, commercialization, and expansion strategies.

Before venturing into the healthcare and diagnostics sectors, Josh gained valuable operational experience in the manufacturing industry. As part of the team at Industrial Timber, a startup manufacturer, he was responsible for managing and establishing multiple manufacturing facilities across the southeastern United States.

Josh holds an MBA from the University of Mississippi.

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iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.

Order Request

iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.

Order Request

iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.

Order Request

iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.

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iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.

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