dd-cfDNA Test for Solid Organ Transplant Recipients

An innovative NGS-based solution that enables dd-cfDNA blood testing as a kit for laboratory implementation or send out service.*

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What is cfDNA?

Cell-free DNA: A Clear Biomarker for Organ Injury

Cell-free (cfDNA) is fragmented DNA in the bloodstream that originates from cells undergoing cell injury and death.

AlloSeq cfDNA measures cfDNA, and uses single nucleotide polymorphisms (SNPs) to distinguish between donor and recipient.

dd-cfDNA is a powerful, minimally invasive tool for organ transplant surveillance.

How is dd-cfDNA Used?

Allograft Surveillance with dd-cfDNA Testing: Assessment of Injury Risk

AlloSeq cfDNA - Assessment of Injury Risk

How is it Used in Action to Protocols with Ease?

What is AlloSeq cfDNA?

AlloSeq cfDNA is a minimally invasive blood test that measures the amount of donor-derived cell-free DNA (dd-cfDNA) for transplant surveillance. It is currently only available outside of the United States.

AlloSeq cfDNA Kit

NGS based test to run in your own lab and does not require prior genotyping
Targets 202 bi-allelic SNPs across 22 autosomes
Test up to 24 samples/run that is validated on Illumina MiniSeq and MiSeq
Analytically validated by multi-centric study
From cfDNA sample to reported result < 24 hrs with < 1.5 hrs hands-on time
Allows reporting dd-cfDNA as fraction
Ability to calculate absolute copies and monitor more than one donor cfDNA contributor

AlloSeq cfDNA Service (Currently available in Europe)

Alternate way to send your samples into the CareDx lab to validate or use AlloSeq cfDNA without needing NGS equipment
Simple sample collection process with an easy-to-interpret report delivered directly to you
More information can be found here

AlloSeq cfDNA is Based on the Clinically Validated AlloSure** Across Multiple Solid Organs with Data-driven Insights from Multi-center Studies

AlloSure is the dd-cfDNA surveillance service that has been clinically and analytically validated for identifying kidney, heart and lung injury.
AlloSure is the most published dd-cfDNA test in transplantation with over 100+ peer reviewed journal publications.

Interpretation of dd-cfDNA Results in Kidney, Heart and Lung Transplantation

At varying levels provides meaningful, actionable information to your existing clinical setting.

Cut-off values suggested are clinically validated by CareDx with service modality AlloSure for assessing the risk of allograft rejection.

Want to Order AlloSeq cfDNA Surveillance Tests?

AlloSeq cfDNA Service: Send in samples to CareDx central lab in Stockholm, Sweden, Email: servicetesting@caredx.com or call +46-8-50893900

AlloSeq cfDNA Kit: To learn more about how to bring AlloSeq cfDNA to your own lab, contact your CareDx representative or reach out to us:

Americas: orders-US@caredx.com

EMEA: orders-se@caredx.com

APAC: orders-aus@caredx.com

Ordering Information

Product	No. RXNs	Product Code
AlloSeq cfDNA – IVD	24	ASCF.1(24)-IVD
AlloSeq cfDNA – RUO	24	ASCF.1(24)
AlloSeq cfDNA Software	N/A	ASCFS1.0
AlloSeq cfDNA Service- RUO only	N/A	N/A

Product	No. RXNs
AlloSeq cfDNA – IVD ASCF.1(24)-IVD	24
AlloSeq cfDNA – RUO ASCF.1(24)	24
AlloSeq cfDNA Software ASCFS1.0	N/A
AlloSeq cfDNA Service- RUO only N/A	N/A

References

Bu L, et al. Clinical outcomes from the Assessing Donor-derived cell-free DNA Monitoring Insights of kidney Allografts with Longitudinal surveillance (ADMIRAL) study. Kidney Int. 2022 Apr;101(4):793-803.
Grskovic M, et al. Validation of a Clinical-Grade Assay to Measure Donor- Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn. 2016 Nov;18(6):890-902.
Khush KK, et al. Noninvasive detection of graft injury after heart transplant using donor-derived cell-free DNA: A prospective multicenter study. Am J Transplant. 2019 Oct;19(10):2889-2899.2019 Oct;19(10):2889-2899.
Sayah D, et al. Plasma Donor-derived Cell-free DNA Levels Are Increased During Acute Cellular Rejection After Lung Transplant: Pilot Data. Transplant Direct. 2020 Sep 24;6(10):e608.
Khush KK, et al. Donor-derived, cell-free DNA levels by next-generation targeted sequencing are elevated in allograft rejection after lung transplantation. ERJ Open Res. 2021 Jan 25;7(1):00462-2020.
Bloom RD, et al. Circulating Donor-Derived Cell-Free DNA in Blood for Diagnosing Active Rejection in Kidney Transplant Recipients (DART) Study Investigators. Cell-Free DNA and Active Rejection in Kidney Allografts. J Am Soc Nephrol. 2017 Jul;28(7):2221-2232.
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry (KOAR). ClinicalTrials.gov Identifier: NCT03326076
Pai A, et al. Clinical Rationale for a Routine Testing Schedule Using Donor- Derived Cell-Free DNA After Kidney Transplantation. Ann Transplant. 2021 Jul 2;26:e932249.
Pham MX, et al; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900.
Surveillance HeartCare^{^®} Outcomes Registry (SHORE). ClinicalTrials.gov Identifier: NCT03695601
Keller M, et al. Donor-derived cell-free DNA as a composite marker of acute lung allograft dysfunction in clinical care. J Heart Lung Transplant. 2022 Apr;41(4):458-466.
AlloSure Lung Assessment and Metagenomics Outcomes Study (ALAMO). ClinicalTrials.gov Identifier: NCT05050955

*AlloSeq cfDNA is available only outside the US. For local regulatory status, please contact CareDx. AlloSeq Service is Research Use Only. Research Use Only products are not to be used for diagnostic procedures. AlloSeq is a trademark or registered trademark of CareDx Inc. or its subsidiaries in the US or other countries. AlloSeq is a registered trademark with the US Patent and Trademark Office.
**AlloSure is available as a dd-cfDNA service within the US only.