Large Real-World Study with Renasight Genetic Test Highlights High Diagnostic Yield for Patients with Chronic Kidney Disease
AUSTIN, Texas, April 19, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, announced the results of a large, real-world study1 demonstrating a high yield rate for positive genetic findings with its Renasight™ test in patients with chronic kidney disease (CKD).
The study, published in the American Journal of Nephrology, reports on renal genetic testing results using Renasight to test for 382 genes associated with CKD on 1,007 unique patient samples that were ordered by general and transplant nephrologists for clinical purposes. Positive genetic findings were identified in 21.1% of cases, with a total of 220 positive results identified across 48 genes. In addition, the results also identified individuals with positive findings in more than one gene. The study concludes that Renasight, "is highly effective in identifying monogenic variants underlying inherited kidney diseases and has utility for genetic diagnoses in the nephrology setting."
"Previous studies have focused on selected cohorts in an academic setting or tested an unselected population with CKD to determine the prevalence of genetic disorders causing kidney disease," said Anthony J. Bleyer, M.D., the study’s principal investigator. "We believe this is the first real-world study to show that genetic testing for many conditions offers several advantages in a clinical setting, compared to the current practice of screening for individual disorders in a stepwise manner, which may not identify causative variants and can be expensive and time consuming."
"This study shows that Renasight can help inform CKD prognosis, personalize treatments, inform counseling and testing of at-risk relatives, influence reproductive decision-making, and enable referrals for evaluation of extrarenal manifestations," said Maggie Westemeyer, co-author and associate director of genetic counseling at Natera. "For the 37 million adults affected by CKD, including 800,000 individuals with end-stage kidney disease in the U.S. alone, genetic diagnosis may inform the selection of potential-related kidney donors, assess the risk of disease recurrence, and guide clinical management following transplant."
Renasight is a genetic test that uses next-generation sequencing (NGS) and other methodologies to identify germline genetic factors causing or contributing to kidney disease from a patient’s blood or buccal sample. The test identifies certain autosomal dominant, autosomal recessive and X-linked disorders, including well-known risk alleles. Providers can use Renasight 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.
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, and 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 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
- Bleyer AJ, Westemeyer M, Xie J, et al. Genetic Etiologies for Chronic Kidney Disease Revealed through Next-Generation Renal Gene Panel. Am J Nephrol. 2022 Mar 24:1-10. doi: 10.1159/000522226.
SOURCE Natera, Inc.