Join Our Clinical Research Program

We are ready to invite external laboratories to participate in the evaluation of HoloGRAFT™. Join our Clinical Research Program and evaluate measuring the absolute concentration of donor-derived cfDNA with HoloGRAFT™ as a biomarker for graft injury in your own lab.

Background Information

The HoloGRAFT™ Screening Plates, Monitoring Assays and HoloGRAFT™ Software meet the needs of any research application that requires highly sensitive detection and quantification of graft-derived, cell-free DNA after organ transplantation.

HoloGRAFT uses copy number variant markers, stretches of DNA inherited in zero, one or two-copy forms. The donor-informative markers, as well as their detected amplicons, are missing in the patient. The detected amplicons are subsets of the variants, in contrast to SNP-based alternatives, where the variants are subsets of the detected amplicons. Therefore, HoloGRAFT is the only cfDNA method with a negative background.

  • The use of donor-derived cell-free DNA (dd-cfDNA) is evidence-based and validated, and a prime example of much-needed innovation in transplant organ surveillance. It has demonstrated utility in the early detection of allograft injury and assistance with clinical decision-making regarding allograft biopsy and treatment initiation.
  • Dd-cfDNA is a better discriminator of acute kidney rejection than serum creatinine. (Bloom et al, 2017) [1]
  • Elevated dd-cfDNA levels are associated with an increased likelihood of de novo DSA development in kidney recipients. (Jordan et al. 2018)[2]
  • Elevated dd-cfDNA levels are found to predict longitudinal eGFR decline, while normal levels did not have evidence of eGFR decline during the period of study follow-up. (Stites et al. 2020)[3]
  • The accumulated evidence supporting the use of dd-cfDNA argues that its use should no longer be considered investigational. (ASTS Position Statement)[4]



[1] Bloom RD, Bromberg JS, Poggio ED, et al. Cell-free DNA and active rejection in kidney allografts. JASN. 2017;28:2221-2232.

[2] Jordan SC, Bunnapradist S, Bromberg JS, et al. Donor-derived cell-free DNA identifies antibodymediated rejection in donor specific antibody positive kidney transplant recipients. Transplant Direct. 2018. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133406/.

[3] Stites E, Kumar D, Olaitan O, et al. High levels of dd-cfDNA identify patients with TCMR 1A and borderline allograft rejection at elevated risk of graft injury. Am J Transplant. 2020;20:2491-2498 PMID 32056331.

[4] ASTS Statement on donor-derived cell-free DNA (dd-cf-DNA) Approved by the ASTS Executive Committee on March 6, 2023  https://asts.org/docs/default-source/position-statements/dd-cfdna-position-statement.pdf


Designed to measure absolute concentration of donor-derived cfDNA in your own laboratory

SW solution provides complete, streamlined workflow for assay set up, analysis and full graphic reporting of monitoring data

Able to distinguish the patient and donor DNA fragments

From DNA samples to results in 3 hours

Graft-informative markers selected to be absent in the patient DNA

Fast & simple with low hands-on time

Advanced Technologies That Will Change the Transplantation Medicine is Practiced Today

Product Overview

The HoloGRAFT™ System consists of DNA Screening plates, 43 individual monitoring assays, dPCR Master Mix, and HoloGRAFT™ Software. The HoloGRAFT™ Copy Number Variant (CNV) Assays are a set of 43 genetic markers that are able to differentiate, and then quantify, donor-derived DNA. HoloGRAFT™ Software guides the user through reaction set-up for both screening and quantification and analyzes the collected data. The procedure for determining the amount of donor-derived cfDNA in a sample consists of two parts: a Screening test and a monitoring test.

Screening Test

The presence or absence of copy-number variant markers in the recipient and the donor is determined using a HoloGRAFT™ Screening Plate. A donor-informative assay measures a marker that is present (positive) in the donor and absent (negative) in the recipient’s genome.

Monitoring Test

The HoloGRAFT™ CNV assays are digital polymerase chain reaction (dPCR) assays based upon self-quenched, hydrolysis probe chemistry. Each assay is pre-mixed with an RNaseP control gene assay, in order to quantify both the amount of donor cfDNA and the total cfDNA in a single reaction.

HoloGRAFT™ Software

HoloGRAFT™ Software was designed specifically for the HoloGRAFT™ CNV Assay Set. The software provides a streamlined workflow for both the Screening and quantification tests. The software guides the user through assay setup, performs data analysis, generates results reports, and stores the data collected for samples over time.

Measure cfDNA in your own lab

Would you like to participate and benefit from our Clinical Research Program? Please contact your local Omixon representative at our sales department at sales@omixon.com and we will provide you with all the necessary information to start HoloGRAFT™ with Omixon.

DISCLAIMER: The HoloGRAFT™ solution may vary from the final product with respect to protocol, software user interface. RUO Research Use Only Product - Not For Diagnostic Use