In its LCD, Noridian states, "Prospera is an effective, non-invasive method of assessing kidney allograft status with better performance than the current standard-of-care." It also states, "The evidence is sufficient to support that Prospera provides a non-invasive assessment tool to assess for the presence of active allograft rejection." Furthermore, "The evidence also supports that Prospera identifies both ABMR [antibody-mediated rejection] and TCMR [T-cell mediated rejection], and it is validated to detect subclinical AR [active rejection]." Final LCD issuance is expected soon, allowing
"I am pleased with our progress towards achieving
There are more than 190,000 people living with a kidney transplant in the U.S.1 and roughly 20,000 new kidney transplant surgeries are performed each year.2 It is estimated that 20-30 percent of organ transplants fail within five years, and approximately 50 percent fail within 10 years.3,4 Traditional tools for diagnosing organ transplant rejection are either invasive (biopsies) or inaccurate (serum creatinine), creating a strong unmet need for better diagnostic tools to help optimize immunosuppression levels, avoid unnecessary biopsies, and improve graft survival.
The proposed LCD is posted on the
About the Prospera dd-cfDNA Organ Transplant Test
The Prospera test leverages
The Prospera test has been clinically and analytically validated for performance independent of donor type, rejection type, and clinical presentation. In repeatability and reproducibility studies, it showed superior precision with a coefficient of variation up to five times better than that of a competitive dd-cfDNA assay (1.85% vs. 9.2% within run; 1.99% vs. 4.5% across runs).5,6 In clinical validation,
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that
The test was developed by
- Kidney Disease Statistics for
the United States. National Institute of Diabetes and Digestiveand Kidney Diseases. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease. Published Dec. 1, 2016.
- 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.
- Stegall MD, Gaston RS, Cosio FG, Matas A. Through a glass darkly: seeking clarity in preventing late kidney transplant failure. J Am Soc Nephrol. 2015;26(1):20-9.
- Lamb KE, Lodhi S, Meier-Kriesche HU. Long-term renal allograft survival in
the United States: a critical reappraisal. Am J Transplant. 2011;11(3):450-62.
- 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.
- 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.
- 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.
- 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.
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