Oncocyte is now iMDx! Click here to learn more.

Login

CONTACT US

Login

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

INFORMATION REQUEST

Product Highlights

Clinical Evidence

Resources

FAQs

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.

Collaborate With Us

Get started with

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.

View Our Data

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

CONTACT US

PRODUCT HIGHLIGHTS

Why GraftAssureCore

For Fast and Informed Decisions in Transplant Care

KIDNEY
LIVER

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.

NEED TITLE

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

NEED TITLE

Rejection may be detected before clinically suspected damage8

NEED TITLE

Accelerated turnaround time

NEED TITLE

Allows for early and real-time intervention

NEED TITLE

Avoids unnecessary invasive biopsies

See Our Clinical Evidence

KIDNEY
LIVER

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

SEE OUR DATA

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

SEE OUR DATA

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
COLLABORATE WITH US

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.

SEE OUR DATA

TAGLINE

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
CONTACT US

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
CONTACT US

TAGLINE

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
CONTACT US

TAGLINE TITLE

Provider Resources

KIDNEY
LIVER

KIDNEY CLINICAL SUMMARY

Mayer KA, et al. (2024)

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

VIEW RESOURCE >

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.

VIEW RESOURCE >

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.

VIEW RESOURCE >

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.

VIEW RESOURCE >

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.

VIEW RESOURCE >

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.

VIEW RESOURCE >

Patient Resources

KIDNEY INFORMATION SHEET

Intro to VitaGraft Kidney

For nephrologists, surgeons and clinical transplant professionals.

VIEW RESOURCE >

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.

VIEW RESOURCE >

GraftAssureCore

GraftAssureCore Patient Billing Brochure

For information on insurance coverage for GraftAssureCore.

VIEW RESOURCE >

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.

VIEW RESOURCE >

LIVER INFORMATION SHEET

Intro to VitaGraft Liver

For hepatologists, surgeons, and clinical transplant professionals.

VIEW RESOURCE >

GET SOME ANSWERS

Frequently Asked Questions

Please choose a category
  • Category A
  • Category B
  • Category C
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.

Faqs Category B 1
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse vitae lectus in purus accumsan malesuada. Aenean gravida nisl non ipsum mattis, eu dapibus ipsum euismod. Aliquam erat volutpat. In ultricies eu dui nec fringilla. Donec tempor nulla velit, in lacinia libero pretium at. Morbi lacinia, sapien vel ullamcorper semper, ex nibh vehicula neque, nec cursus dui leo eget leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse vitae lectus in purus accumsan malesuada. Aenean gravida nisl non ipsum mattis, eu dapibus ipsum euismod. Aliquam erat volutpat. In ultricies eu dui nec fringilla. Donec tempor nulla velit, in lacinia libero pretium at. Morbi lacinia, sapien vel ullamcorper semper, ex nibh vehicula neque, nec cursus dui leo eget leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse vitae lectus in purus accumsan malesuada. Aenean gravida nisl non ipsum mattis, eu dapibus ipsum euismod. Aliquam erat volutpat. In ultricies eu dui nec fringilla. Donec tempor nulla velit, in lacinia libero pretium at. Morbi lacinia, sapien vel ullamcorper semper, ex nibh vehicula neque, nec cursus dui leo eget leo.
Faqs Category C 1
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse vitae lectus in purus accumsan malesuada. Aenean gravida nisl non ipsum mattis, eu dapibus ipsum euismod. Aliquam erat volutpat. In ultricies eu dui nec fringilla. Donec tempor nulla velit, in lacinia libero pretium at. Morbi lacinia, sapien vel ullamcorper semper, ex nibh vehicula neque, nec cursus dui leo eget leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse vitae lectus in purus accumsan malesuada. Aenean gravida nisl non ipsum mattis, eu dapibus ipsum euismod. Aliquam erat volutpat. In ultricies eu dui nec fringilla. Donec tempor nulla velit, in lacinia libero pretium at. Morbi lacinia, sapien vel ullamcorper semper, ex nibh vehicula neque, nec cursus dui leo eget leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse vitae lectus in purus accumsan malesuada. Aenean gravida nisl non ipsum mattis, eu dapibus ipsum euismod. Aliquam erat volutpat. In ultricies eu dui nec fringilla. Donec tempor nulla velit, in lacinia libero pretium at. Morbi lacinia, sapien vel ullamcorper semper, ex nibh vehicula neque, nec cursus dui leo eget leo.

Get started with

GraftAssureCore™ today!

Click below to set up an onboarding call with one of our specialists.

SET UP CONSULTATION

Follow Us

Company

About Us

Careers

Transplant

GraftAssureCoreTM

GraftAssureDxTM

GraftAssureIQTM

Legal

Privacy Policy

Website Terms of Use

Terms and Conditions of Sale

HIPAA Notice of Privacy Practices

©2025 Insight Molecular Diagnostics Inc. All rights reserved. iMDx, GraftAssureCore, GraftAssureIQ, GraftAssureDx, DetermaIO, DetermaCNI, and OncoTIME are trademarks of Insight Molecular Diagnostics Inc. All other trademarks are the property of their respective owners. For the intended uses of all products, please refer to www.imdxinc.com.

WEBSITE BY: LEFT HAND DESIGN

GraftAssureCore™ References

1. Oellerich M, Shipkova M, Asendorf T, 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. (189 patients) 2. Akifova A, Budde K, Choi M, et al. (2023). Donor-Derived Cell-Free DNA in Biopsy-Proven Antibody-Mediated Rejection Versus Recurrent IgA Nephropathy After Kidney Transplantation. Kidney International Reports doi:10.1016/j.ekir.2023.07.011. (73 patients) 3. Schutz E, Asendorf T, Beck J, 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. (303 patients) 4. Osmanodja B, Akifova A, Budde K, et al. (2021). Absolute or Relative Quantification of Donor-derived Cell-free DNA in Kidney Transplant Recipients: Case Series. Transplant Direct 7(11):e778. (22 patients) 5. Mayer KA, Schrezenmeier E, Diebold M, et al. (2024) A Randomized Phase 2 Trial of Felzartamab in ABMR. NEJM DOI: 10.1056/NEJMoa2400763. (22 patients) 6. Osmanodja B, Akifova A, Budde K, et al. (2024). Donor-Derived Cell-Free DNA as a Companion Biomarker for AMR Treatment with Daratumumab: Case Series. Trans Int 37:13213. 7. Akifova A, Osmanodja B, Amann K, et al. (2024). Donor-derived cell-free DNA monitoring for early diagnosis of antibody-mediated rejection after kidney transplantation: a randomized trial. Nephrology Dialysis Transplantation DOI: 10.1093/ndt/gfae282. (26 patients) 8. Schütz E, Fischer A, Beck J, 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. 9. Baumann AK, Beck J, Kirchner T, et al. (2022) Elevated fractional donor-derived cell-free DNA during subclinical graft injury after liver transplantation. Liver Transpl 28(12):1911. 10. Oellerich M, Schütz E, Kanzow P, 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):136-40. 11. Kanzow P, Kollmar O, Schütz E, et al. (2014). Graft-derived cell-free DNA as an early organ integrity biomarker after transplantation of a marginal HELLP syndrome donor liver. Transplantation 98(5):e43-5. 12. Knüttgen F, Beck J, Dittrich M et al. (2022). Graft-derived Cell-free DNA as a Noninvasive Biomarker of Cardiac Allograft Rejection: A Cohort Study on Clinical Validity and Confounding Factors. Transplantation 106(3):615-622. 13. Osmanodja B, Akifova A, Oellerich M, et al. (2023). Donor-Derived Cell-Free DNA for Kidney Allograft Surveillance after Conversion to Belatacept: Prospective Pilot Study. J Clin Med doi:/10.3390/jcm12062437 14. Akifova A, Budde K, Choi M, et al. (2025). Association of Blood Donor-derived Cellfree DNA Levels With Banff Scores. Transplant Direct 11: e1794; doi: 10.1097/TXD.0000000000001794

Information 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.

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.

Information 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.

Thanks for your interest in