Prospera Transplant Assessment | Clinician Information | Natera

New Editorial in Kidney 360 compares dd-cfDNA assays.

IN THE NEWS

Natera receives final Medicare Coverage for Prospera transplant assessment test


Prospera Transplant Assessment Test

 


1. Highly optimized to significantly reduce variability

Based on analytical validation data, Prospera exhibited up to 5x less variability in results.1,3

Patient Test Summary Example

T1 cfDNA result: 0.4%
T2 cfDNA result: 0.6%


 

 

Depending on the cfDNA lab chosen, the percent change in the dd-cfDNA level could have a range as large as 35%-65% (first-generation cfDNA testing), or as small as 47.5%-52.5% (Prospera)1,3 - whereas the true percent change is 50%.

*Depicted ranges are ±1 standard deviation from actual dd-cfDNA level based on coefficient of variations.1,3

 

2. Now—catch ALL rejection types with a single blood draw

Prospera’s unique ability to identify T cell-mediated rejection gives a more comprehensive view of your patient’s rejection status.2,5

Prospera is the first cfDNA assay to publish performance in surveillance situations, providing results that can enable physicians to manage patients with previously unsuspected rejection.2

3. Lower risk of missing active rejection

In the event of a result with dd-cfDNA level <1%, Prospera is three times less likely to miss an active rejection† than first-generation dd-cfDNA.2,4

Comparison of Negative Predictive Values (NPV) from published validation studies


4. Ultra-sensitive for more accurate classification

When comparing published clinical validation studies, Prospera demonstrated better performance in correctly classifying patients with active rejection—including cell-mediated rejection.2,5

Other tests may incorrectly classify patients experiencing active rejection as normal (up to 1 out of 2 cases).5

Of 100 active rejection cases, the number of patients who would be missed, and told they are normal‡


Clinician Support

Natera backs you and your care team with ongoing support and resources so you can easily incorporate Prospera into your clinical workflow.

Resources to help clinicians:

  • Direct support from clinical staff to discuss your patients’ results
  • Prospera Provider Portal plus EMR integration options so you can easily order, track and receive patients’ reports

 

Our initiatives specifically for your transplant nurses and coordinators:

  • Dedicated operations team to ensure ease of integration into your current patient care workflow
  • Participation in our ProsperaLink Patient Program so your team can help patients stay updated on their blood draws, compliance plan and results
  • Complimentary mobile phlebotomy services for added convenience
  • Proactive billing outreach and price transparency so you don’t need to have those discussions


References

  1. Altuğ Y, Liang N, Ram R, et al. Analytical validation of a single-nucleotide polymorphism-based donor-derived cell-free DNA assay for detecting rejection in kidney transplant patients. Transplantation, 2019
  2. Sigdel TK, Archila FA, Constantin T, et al. Optimizing detection of kidney transplant injury by assessment of donor-derived cell-free DNA via massively multiplex PCR. J Clin Med. 2019;8(1):19.
  3. Grskovic M, Hiller DJ, Eubank LA, et al. Validation of a clinical-grade assay to measure donor-derived cell-free DNA in solid organ transplant recipients. J Mol Diagn. 2016;18(6):890-902.
  4. Bloom RD, Bromberg JS, Poggio ED, et al. Cell-free DNA and active rejection in kidney allografts. J Am Soc Nephrol. 2017;28(7):2221-2232. doi: 10.1681/ASN.2016091034.
  5. Huang, et al. Early clinical experience using donor‐derived cell‐free DNA to detect rejection in kidney transplant recipients. Transplantation. 2019, doi: 10.1111/ajt.15289
  6. Stegall et al, Through a Glass Darkly: Seeking Clarity in Preventing Late Kidney Transplant Failure, J Am Soc Nephrol. 2015; 26 (1):20-9
  7. 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.
  8. Organ Donation Statistics. U.S. Department of Health and Human Services. U.S. Government Information on Organ Donation and Transplantation. www.organdonor.gov. Published March 31, 2016.
  9. Kidney Disease Statistics for the United States. National Institute of Diabetes and Digestive and Kidney Diseases. www.niddk.nih.gov. Published Dec. 1, 2016.