Natera Announces Definitive Study to Evaluate the Clinical Utility of Renasight in the Diagnosis and Management of Chronic Kidney Disease (CKD)
RenaCARE study expected to be fully enrolled by end of Q2 of 2022
AUSTIN, Texas, April 26, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the RenaCARE (Renasight Clinical Application, Review and Evaluation) study – a real world, prospective, multi-center clinical study to assess the clinical utility of the Renasight™ genetic testing panel. The study has already enrolled 1,600 patients across 25 sites, representing leading academic and private nephrology clinics in the U.S., and will enroll up to 2,000 patients. It is expected to complete enrollment in the second quarter of 2022 with a publication expected to be submitted in late 2022.
The study aims to demonstrate how genetic findings impact the management of patient care and examines diagnostic outcomes of patients tested with the Renasight genetic testing panel. In addition, the study will assess patient satisfaction, health knowledge and genetic literacy. This study follows a 2019 publication1 in The New England Journal of Medicine (NEJM) showing that 89% of patients who tested positive with a multi-gene genetic test had actionable clinical implications.
"Chronic kidney disease affects more than 10% of the global population, and our 2019 NEJM study showed roughly a 10% genetic yield among CKD patients," said Ali Gharavi, M.D., 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, interim director of the Institute of Genomic Medicine at Columbia University Vagelos College of Physicians and Surgeons, the study’s principal investigator and a close collaborator with Kidney Disease: Improving Global Outcomes foundation (KDIGO) and the National Kidney Foundation (NKF). "We’re optimistic that this study will show that next-generation sequencing (NGS) multi-gene assays can be used in a real world setting, to inform and guide disease management and help improve patient outcomes."
"We’re confident that the RenaCARE study will confirm the high clinical utility shown in prior studies. This will be an important addition to the growing body of evidence showing the value of genetic testing to clarify an undifferentiated diagnosis, identify a genetic subtype within a diagnosis, reclassify a diagnosis, or provide insights for genetic counseling, family planning and clinical trial access," said Hossein Tabriziani, M.D., senior medical director of organ health for Natera.
All patients undergoing testing using the Renasight panel are offered optional pre- and post-test genetic information sessions with a genetic counselor in addition to their test results. Similarly, providers have access to Natera’s genetic counselors for questions about the Renasight testing panel and review of test results.
Natera designed and launched the Renasight genetic testing panel with the feedback of general nephrologists, pediatric nephrologists, and transplant nephrologists. Natera has performed over 10,000 Renasight tests to date.
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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 firstname.lastname@example.org
- 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.