A Precise Genetic Testing Solution for Solid-organ Transplant Surveillance

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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.

• 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.

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.

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

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 and AlloSeq cfDNA Software is available as CE/IVD and Research Use only. AlloSeq cfDNA service testing in Stockholm, Sweden is ISO 17025 accredited. For local regulatory status, please contact CareDx. AlloSeq cfDNA is only available outside of the United States. 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. Research Use Only products are not to be used for diagnostic procedures.

**AlloSure is available as a dd-cfDNA service within the US only.

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