Medicare Issues Draft Local Coverage Determination for Natera’s New Prospera™ Kidney Transplant Rejection Test
This draft coverage determination represents a major reimbursement milestone on the company's path to commercialization. In its draft LCD, Medicare 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]."
"I am pleased with the draft coverage decision and look forward to working with Medicare to make this test accessible for those in greatest need," said
There are more than 190,000 people living with a kidney transplant in the
The Prospera test detects allograft rejection noninvasively and with high accuracy, by measuring the fraction of dd-cfDNA in the patient's blood, without the need for prior donor or recipient genotyping. Recently published validation studies show Prospera's superior precision and superior clinical accuracy, relative to other commercially available dd-cfDNA assays.5,6 Prospera is the first assay with high sensitivity to both T-cell mediated and antibody mediated rejection,5,7 and it is the first to detect subclinical rejection, which occurs in 20-25 percent of patients in the first two years post-transplant5,8 and is considered a major driver of graft failure. This test performance is a direct result of Natera's experience using its core SNP-based cell-free DNA technology to analyze over 1.5 million Panorama tests from pregnant women.
The draft LCD is posted on the
About the Prospera dd-cfDNA organ transplant test
The Prospera test is intended to supplement the evaluation and management of kidney (renal) injury and active rejection in patients who have undergone organ transplantation. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood, which can spike relative to background recipient cfDNA when the transplanted organ is injured due to immune rejection. The test leverages Natera's core single-nucleotide polymorphism (SNP)-based massively multiplexed PCR (mmPCR) technology to accurately measure dd-cfDNA levels without the need for donor genotyping.
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).6, 9 In clinical validation, Natera reported higher sensitivity (89% vs. 59%) and higher area under the curve (0.87 vs. 0.74) than the competing dd-cfDNA assay.5, 7
About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our ability and expectations regarding obtaining, maintaining and expanding third-party payer coverage of, and reimbursement for, our tests, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the
The test was developed by
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References
- 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. PublishedDec. 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. PublishedMarch 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. - 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.
- 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
- 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.
- Choi BS, Shin MJ, Shin SJ, et al. Clinical significance of an early protocol biopsy in living-donor renal transplantation: Ten-year experience at a single center. Am J Transplant. 2006;5:1354-1360.
- 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.
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