New Data in Simultaneous Pancreas-Kidney Transplantation Further Demonstrates the Value of Prospera dd-cfDNA Technology

Biopsy-matched study assesses pancreas rejection in the context of a simultaneous kidney-pancreas transplant

AUSTIN, Texas, March 22, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that a study¹ reporting on the performance of donor-derived cell-free DNA (dd-cfDNA) testing using the Prospera™ technology for the assessment of pancreas graft rejection in simultaneous pancreas-kidney (SPK) transplantation has been published in Transplantation, the official Journal of The Transplantation Society.

The study, conducted at the Hospital Clinic of Barcelona, Spain, utilized Prospera technology to detect rejection of a pancreas graft in 36 SPK transplant recipients with pancreas biopsy-matched plasma samples. Pancreas graft status in SPK transplants is currently assessed by non-specific biochemical markers, typically amylase and/or lipase, and confirmed by biopsy.

As shown in the study results, the combination of dd-cfDNA donor fraction and quantity reported using Prospera technology outperformed both current biochemical markers and dd-cfDNA donor fraction-alone in assessing pancreas rejection. Dd-cfDNA quantity alone also demonstrated exceptional performance, detecting rejection with a sensitivity of 85.7% and a specificity of 93.7% and achieving an AUC of 0.89 compared to 0.74 for lipase and 0.46 for amylase.

"Our study clearly indicates that the use of routine dd-cfDNA testing can help clinicians better monitor and manage treatment options, particularly over the current tests which are highly unspecific," said Pedro Ventura-Aguiar, M.D., Ph.D., the study's author and principal investigator. "This data also cements the importance of incorporating dd-cfDNA quantity and not just looking at donor-fraction alone. It's great that Natera can enable this type of analysis with Prospera."

"We've previously validated the Prospera test for use in the clinical management of simultaneous pancreas-kidney transplant patients to detect kidney rejection," said Bernie Tobin, general manager, organ health at Natera. "New advances may enable the ability to detect pancreatic rejection as well. SPK transplant recipients face a complex array of challenges and we're pleased to be on the leading edge of research and striving to improve care for these patients."

The Prospera test leverages Natera's core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction and quantity of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. 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 Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

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, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening 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.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]

1. Ventura-Aguiar P, Ramirez-Bajo MJ, Rovira J, et al. Donor-derived Cell-free DNA Shows High Sensitivity for the Diagnosis of Pancreas Graft Rejection in Simultaneous Pancreas-Kidney Transplantation. Transplantation. 2022. DOI: 10.1097/TP.0000000000004088.

SOURCE Natera, Inc.

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