why prospera | Natera

Why Prospera Explore real-world use cases

Our Prospera™ transplant assessment test is a non-invasive blood test that can help you comprehensively identify all types of active rejection with great precision.6

Use Case: For cause, avoid complicated biopsy

 

Providers caring for transplant patients need a non-invasive alternative to guide decisions on whether a complicated patient requires a biopsy to confirm rejection.

10.3% of biopsies have complications 1

The Clinical Scenario

 

If any of your transplant patients are contraindicated for a biopsy, consider Prospera as the first step in assessing kidney rejection.

Relative contraindications2

  • Unusual position of kidney
  • Uncorrectable bleeding diathesis3, 4
  • Active renal or perirenal infection
  • Skin infection over the biopsy site
  • Morbid obesity

Absolute contraindications2

  • Uncontrolled severe hypertension
  • Anticoagulated5
  • Uncooperative patient

Why Prospera

 

With precision based on superior clinical performance,6, 7 Prospera can guide rejection assessment in tough biopsy scenarios.

Prospera’s published sensitivity indicates roughly 9 out of 10 patients in rejection were correctly identified.6

Prospera’s published sensitivity indicates roughly 9 out of 10 patients in rejection were correctly identified | Natera

Prospera provides greater confidence when ruling out active rejection.

Physicians may use this assay to determine which patients may require a biopsy to confirm active rejection.

~3x fewer rejections missed

NPV: 95%
~3x fewer rejections missed using Prospera | Natera
Prospera15% missed
NPV: 84%
~3x fewer rejections missed using Prospera | Natera
First generation dd-cfDNA216% missed

Based upon 25% prevalence of active rejection.

We see many patients where bleeding is a concern and relying on serum creatinine and eGFR alone doesn't always help the clinical judgment. Using Prospera in these situations is comforting for both the clinician and the patient.

Dr. Amit GovilTransplant Nephrologist

 
 
 
 

Learn More About Prospera

 

Natera Academy: Evaluating transplant patients in challenging biopsy settings

 

"Prospera's negative predictive value of 95% means you have another non-invasive option to rule-out active rejection."

 

Dr. Phil Gauthier explains the value that Prospera brings when performing a biopsy is impossible due to contraindications from increased risk of bleeding, underlying infection, severe hypertension, or intra-abdominal kidney.

"When there are complex logistics associated with the ability to perform a biopsy, Prospera can help physicians make better treament decisions."

 

Dr. Hoss Tabriziani covers how Prospera can overcome complex logistics associated with the ability to perform a biopsy - such as transportation, caregiver dependency, work, travel and the COVID-19 pandemic.

References

  1. Plattner, B. W., Chen, P., Cross, R., Leavitt, M. A., Killen, P. D., & Heung, M. (2018). Complications and adequacy of transplant kidney biopsies: A comparison of techniques. The Journal of Vascular Access, 19(3), 291–296. https://doi.org/10.1177/1129729817747543
  2. Whittier, W. Indications for and complications of renal biopsy. In: UpToDate, Lam, Albert (Ed), UpToDate, Waltham, MA, 2020.
  3. Madaio MP. Renal biopsy. Kidney Int 1990; 38:529.
  4. Appel GB. Renal biopsy: How effective, what technique, and how safe. J Nephrol 1993; 6:4.
  5. Shidham GB, Siddiqi N, Beres JA, et al. Clinical risk factors associated with bleeding after native kidney biopsy. Nephrology (Carlton) 2005; 10:305
  6. 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.
  7. 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.

Use Case: Prospera for surveillance in kidney transplant patients

 

Begin at the beginning to prevent the end

Many kidney transplant failures occur within the first five to ten years because organ rejection is not caught early enough and treated effectively. Current surveillance methodologies are not sufficient.

Current surveillance methodologies are not sufficient -

Clinical visits: At certain time intervals, clinical findings may be unreliable and could indicate advanced rejection

Routine labs, including serum creatinine: Lagging indicators that are not specific or sensitive enough to detect allograft rejection

Protocol Biopsies: Not widely used due to cost, logistical support, potential complications, interpretation challenges and patient discomfort

Learn More

~20,000

Kidney transplants performed 
each year in the U.S.1

~190,000

People living with a kidney 
transplant in the U.S.2

~20-30%

Kidney transplant failures within 5 years3

~50%

Kidney transplant failures within 10 years4

The Clinical Scenario

 

How do you prevent late graft loss?

Average allograft survival is only 10 years, and the majority of these grafts are lost due to chronic antibody-mediated rejection.

It has been said that the most effective strategy to improve graft outcomes is to “begin at the beginning” by:

  • Screening for subclinical rejection
  • Treating signs of T cell-mediated rejection

A more comprehensive and accurate rejection assessment test, such as Prospera, can identify active rejection at an eariler, more treatable stage which could possbily prevent more severe complications.

 
 

Why Prospera

 

The Prospera non-invasive blood test can comprehensively identify all types of active rejection with great precision.

Prospera’s published performance is similar in a stable and those with clinical signs of rejection.11

Using the Prospera test in a surveillance setting can enable clinicians to effectively manage transplant patients with unsuspected, subclinical rejection as a way to increase the longevity of their kidney. (Figure 1)

Prospera’s published performance is similar in a stable and those with clinical signs of rejection.11

Assessing for both ABMR and TCMR allows physicians to coordinate earlier, timely clinical management that would have otherwise been missed.

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Figure 1

Active rejection: Clinical AR

Sensitivity: 86%
~3x fewer rejections missed using Prospera | Natera
NPV*: 93.8%
~3x fewer rejections missed using Prospera | Natera

Active rejection: Subclinical AR

NPV: 92%
~3x fewer rejections missed using Prospera | Natera
NPV*: 98.3%**
~3x fewer rejections missed using Prospera | Natera

*Assuming 25% AR Prevelance (higher risk population)

**Assuming 10% AR Prevelance (low risk population)

Prospera is the cfDNA test that gives me the most information when assessing post-transplant recipients during surveillance. When my patient's serum creatinine is elevated from his recurrent FSGS and the Prospera is negative, it tells me that rejection is not occurring.

Dr. Prince MohanTransplant Nephrologist

Natera Academy: Assessing subclinical rejection at an early, treatable stage

 

"If you surveil with Prospera, you can be very confident that you are going to miss very few subclinical rejections"

 

Dr. Phil Gauthier explains the value that Prospera brings when used to rule out subclinical and clinical rejection and avoid unnecessary surveillance biopsies.

"The excellent negative predictive value of the Prospera assay means that physicians have another non-invasive option to rule out rejection while monitoring high risk transplant patients"

 

Dr. Hoss Tabriziani covers how Prospera can be used for surveillance to rule out rejection for patients at high risk for rejection due to a higher antibody state, a history of non-compliance, or a change in their immunosuppression medication.

References

  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-disease. 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
  5. S2018 Annual Data Report Volume 2 ESRD, Chapter 6
  6. Sellares J, de Freiras DG, Mengel M, et al. Understanding the Causes of Kidney Transplant Failure: The Dominant Role of Antibody-Mediated Rejection and Nonadherence. 
 Am J Transp, 2002; 12: 388-399
  7. - Nankivell BJ, Chapman JR. The Significance of Subclinical Rejection and the Value of Protocol Biopsies Am J Transp, 2006;6: 2006-2012
  8. - Mehta R, Sood P, Hariharan S. Subclinical Rejection in Renal Transplantation: REappraised. Transplantation 2016; 100(8): 1610-1618
  9. - Rush D, Nickerson P, Gough J, et al. Beneficial effects of treatment of early subclinical rejection: a randomized study. J Am Soc Nephrol. 1998;9: 2129–2134.
  10. - Kurtkoti J, Sakhuja V, Sud K, et al. The utility of 1- and 3-month protocol biopsies on renal allograft function: a randomized controlled study. Am J Transplant. 2008;8:317–323
  11. - 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.
  12. - 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.