Medicare Issues Draft Local Coverage Determination for Natera's New Prospera™ Kidney Transplant Rejection Test

SAN CARLOS, Calif., March 28, 2019 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that Palmetto MolDx has issued draft local coverage determination (LCD) for use of the company's new Prospera donor-derived cell-free DNA (dd-cfDNA) test to detect active rejection in kidney transplant recipients.

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 Paul Billings, MD, PhD, Natera's Chief Medical Officer.

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.  Medicare coverage is available for kidney transplant patients, regardless of age, as either a primary or secondary insurer for a minimum of 36 months following a successful transplant.

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-transplant^5,8 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 Centers for Medicare and Medicaid Services website and is subject to public comments and further Medicare review before it is finalized.

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 San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including bio pharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com.

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 SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

The test was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Andrea Sampson, Sullivan & Sampson, 714-374-6174, [email protected]

References

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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
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.
8. 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.
9. 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.

SOURCE Natera

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