Natera Announces Enrollment Completion for RenaCARE Study

RenaCARE Study to Evaluate the Clinical Utility of Renasight in the Diagnosis and Management of Chronic Kidney Disease

AUSTIN, Texas, Aug. 11, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced full enrollment for the RenaCARE (Renasight Clinical Application, Review and Evaluation) study, a real world, prospective, multi-center clinical study to assess the clinical utility of Natera's Renasight™ genetic testing panel, which analyzes more than 380 genes related to kidney disease. Enrollment in the study was completed early as a result of statistically meaningful interim data analysis. The study includes more than 1,700 patients across 30+ sites, representing leading academic and private nephrology clinics in the U.S. A publication for the RenaCARE study is expected to be submitted in early 2023.

The RenaCARE study aims to demonstrate how genetic findings impact the clinical management of patient care and examines outcomes of patients tested with the Renasight genetic testing panel. It will also assess patient satisfaction, health knowledge and genetic literacy. The study follows a 2019 publication¹ in The New England Journal of Medicine showing that approximately 10% of people with chronic kidney disease (CKD) have a genetic diagnosis.

"RenaCARE is the only large-scale prospective multi-site study, to our knowledge, looking at the clinical utility of performing routine genetic testing on CKD patients," said Sangeeta Bhorade, M.D., chief medical officer for organ health at Natera. "We're optimistic this study could have the potential to optimize the management of patients with chronic kidney disease and ultimately improve outcomes."

Ali Gharavi, M.D., the study's principal investigator, serves as the chief of the Division of Nephrology at New York-Presbyterian/Columbia University Irving Medical Center, director of the Center for Precision Medicine and Genomics in the Department of Medicine, and interim director of the Institute of Genomic Medicine at Columbia University Vagelos College of Physicians and Surgeons. Dr. Gharavi is also a close collaborator with Kidney Disease: Improving Global Outcomes foundation (KDIGO) and the National Kidney Foundation (NKF).

The Renasight™ test is a germline genetic test that screens for hereditary causes of kidney disease. It is indicated for patients with diagnosed kidney disease and is run from a patient's blood or saliva  sample. Providers can use the Renasight test to identify a genetic predisposition, clarify a clinical diagnosis, or identify the etiology of an unknown kidney disease to help inform medical management. Additionally, genetic counseling and familial testing can be offered based on the test result. The test has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the U.S. 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. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and 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 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: Brian Symmons, SVP of Marketing and Corporate Affairs, Natera, Inc., [email protected]

References

1. Groopman EE, Marasa M, Cameron-Christie S, et al. Diagnostic Utility of Exome Sequencing for Kidney Disease. N Engl J Med. 2019; 380:142-151 DOI: 10.1056/NEJMoa1806891

SOURCE Natera, Inc.