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Thursday, Mar 28, 2024
Mugglehead Magazine
Alternative investment news based in Vancouver, B.C.

Medical and Pharmaceutical

Natera and RenaCARE aim for early detection of kidney disease

natera
by Sangharsh Lohakare on Unsplash

Natera (NASDAQ:NTRA) acquired full enrolment for the RenaCARE (Renasight Clinical Application, Review and Evaluation) study, which is a prospective, multi-center clinical trial to determine the utility and value of Natera’s Renasight genetic testing panel for 380 genes related to kidney disease.

Study enrolment happened as a result of statistically meaningful interim data analysis, including 1,700 patients across 30+ sites, each presenting leading academic and private nephrology clinics in the United States. The RenaCARE study is expected to yield a publication for submission in 2023.

“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. We’re optimistic this study could have the potential to optimize the management of patients with chronic kidney disease and ultimately improve outcomes,” said Sangeeta Bhorade, M.D., chief medical officer for organ health at Natera.

Natera’s business is cell-free DNA testing. The company works on oncology, women’s health and organ health issues, and its aim is to protect health and enable earlier interventions by making personalized genetic testing a part of standard of care. Natera’s tests have been reviewed by more than 100 peer-reviewed publications and have demonstrated 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.

The Renasight test is a germline genetic test that screens for the genetic or hereditary causes of kidney disease. It is indicated and useful for patients with diagnosed kidney disease and is applied using a sample of the patient’s blood or saliva. Providers can use the test to identify a genetic predisposition, clarify a diagnosis, or identify an unknown kidney disease to help inform medical choices. Also, genetic counseling and family testing can be received based on the rest 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.

The aims of the RenaCARE study are to demonstrate how genetic findings impact the clinical management of patient care and examine outcomes of patients tested with the Renasight genetic testing panel. It will include assessments of patient satisfaction, health knowledge and genetic literacy. The study follows a study from a 2019 publication of The New England Journal of Medicine stating that approximately 10 per cent of people with chronic kidney disease (CKD) have a genetic diagnosis.

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