Transplant | Natera

Pursuing earlier,
more precise
assessment
of organ-transplant
rejection

Pursuing earlier,
more precise
assessment
of organ-transplant
rejection

Pursuing earlier,
more precise
assessment
of organ-transplant
rejection

Pursuing earlier,
more precise
assessment
of organ-transplant
rejection

Pursuing earlier, more precise assessment of organ-transplant rejection

Our goal is to help kidney transplant patients thrive

~20k kidney transplants performed in US each year

~190k people living with kidney transplants in the US

~20-30% kidney failures within 5 years

~50% kidney transplant failures within 10 years

Assessing transplanted organ or “allograft” injury and rejection is a challenge with today’s standard of care. Kidney biopsies are invasive and can be risky, costly and of variable quality. Blood tests measuring serum creatinine levels are often not accurate for assessing active rejection and require confirmatory invasive testing. Current standard of care can lead to patients with signs of allograft harm before the opportunity to treat.

There is a great need for earlier, more precise non-invasive tools to assess allograft injury and rejection. Natera has leveraged its expertise in cell-free DNA (cfDNA) prenatal testing to develop a non-invasive assay that may help physicians identify rejection events earlier, avoid unnecessary invasive biopsies, treat before progressing to graft renal failure and ultimately improve patients' transplant experience.

Applying proven cfDNA experience to identify rejection


Natera’s technology can measure the levels of dd-cfDNA shed from the donor organ which may be an indication of the potential of organ injury or rejection.

Proven core technology drives clinical performance

Analytical Validation

  Natera5 Existing Commercial Assay7
 More SNPs targeted & analyzed5 ~ 13,000 266
Precision within run 5x better5
Coefficient of Variation
1.85% 9.2%
Precision across runs 2.3x better5
Coefficient of Variation
1.9% 4.5%
Evaluated assay performance in related and unrelated donors YES NO

Clinical Validation

 
Natera6
Large dd-cfDNA validation study6 217
High overall accuracy6 AUC 0.87
Identification of T-cell mediated rejection6
Sensitivity
100%
Identification of subclinical rejection6
Sensitivity
92%

Proven core technology drives clinical performance

Analytical Validation

  Natera5 Existing Commercial Assay7
 More SNPs targeted & analyzed5 ~ 13,000 266
Precision within run 5x better5
Coefficient of Variation
1.85% 9.2%
Precision across runs 2.3x better5
Coefficient of Variation
1.9% 4.5%
Evaluated assay performance in related and unrelated donors YES NO

Clinical Validation

 
Natera6
Large dd-cfDNA validation study6 217
High overall accuracy6 AUC 0.87
Identification of T-cell mediated rejection6
Sensitivity
100%
Identification of subclinical rejection6
Sensitivity
92%

Proven core technology drives clinical performance

Analytical Validation

  Natera5 Existing Commercial Assay7
 More SNPs targeted & analyzed5 ~ 13,000 266
Precision within run 5x better5
Coefficient of Variation
1.85% 9.2%
Precision across runs 2.3x better5
Coefficient of Variation
1.9% 4.5%
Evaluated assay performance in related and unrelated donors YES NO

Clinical Validation

 
Natera6
Large dd-cfDNA validation study6 217
High overall accuracy6 AUC 0.87
Identification of T-cell mediated rejection6
Sensitivity
100%
Identification of subclinical rejection6
Sensitivity
92%

Proven core technology drives clinical performance

Analytical Validation

  Natera5 Existing Commercial Assay7
 More SNPs targeted & analyzed5 ~ 13,000 266
Precision within run 5x better5
Coefficient of Variation
1.85% 9.2%
Precision across runs 2.3x better5
Coefficient of Variation
1.9% 4.5%
Evaluated assay performance in related and unrelated donors YES NO

Clinical Validation

 
Natera6
Large dd-cfDNA validation study6 217
High overall accuracy6 AUC 0.87
Identification of T-cell mediated rejection6
Sensitivity
100%
Identification of subclinical rejection6
Sensitivity
92%

In the media

Natera Announces Publication of Analytical Validation Study Demonstrating Superior Precision of Its Kidney Transplant Rejection Assay

Natera Announces Agreement with One Lambda to Co-Distribute Its Kidney Transplant Rejection Test

Natera Announces Publication of Kidney Transplant Validation Study, Demonstrating Superior Data in Detection of Clinical and Subclinical Rejection

Natera To Webcast Live Presentation at the 37th Annual J.P. Morgan Healthcare Conference

Contact us

1. Organ Donation Statistics. U.S. Department of Health and Human Services. U.S. Government Information on Organ Donation and Transplantation. https://www.organdonor.gov/statistics-stories/statistics.html. Published March 31, 2016.

2. Kidney Disease Statistics for the United States. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/health-statistics/kidney-di.... Published Dec. 1, 2016.

3. Stegall et al,Through a Glass Darkly: Seeking Clarity in Preventing Late Kidney Transplant Failure, J Am Soc Nephrol. 2015; 26 (1):20-9

4. Lamb et al, Long-term renal allograft survival in the United States: a critical reappraisal, Am J of Transplantation. 2011; Mar;11(3):450-62.5. Altug, et al.

5. Altug, et al. Transplantation. 2019, doi: 10.1097/TP.0000000000002665

6. Sigdel TK, et al. J. Clin. Med. 2019, 8, 19.

7. Grskovic M, et al. J Mol Diagn. 2016;18(6):890-902.

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