New KDIGO Guideline Supports Genetic Testing for the Majority of CKD Patients to Establish Cause of Disease

Supports broader adoption of Natera’s Renasight^TM test

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, commented today on the 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease, which was recently published by the Kidney Disease Improving Global Outcomes (KDIGO) organization, a leading medical society in nephrology. The updated guideline includes consensus statements supporting the use of genetic testing to establish the cause of chronic kidney disease (CKD) for a majority of patients with this condition.

The KDIGO guideline, specifically in Practice Points 1.1.4.1 and 1.1.4.2, states that genetic tests should be used, among other factors, to establish cause for CKD, and that genetic testing can impact the clinical management of people with CKD. The guideline also emphasizes that genetic causes may be present even without a family history; and it references six clinical scenarios, covering the majority of CKD patients, where genetic testing is particularly informative, including:

• Conditions with high prevalence of monogenic subtypes within the clinical category;
• Early age of onset of CKD;
• Syndromic/multisystem features;
• Consanguinity;
• Possibility of identifying a condition amenable to targeted treatment; and
• CKD/ESRD of unknown etiology when kidney biopsy would not be informative due to advanced disease.

The guideline also lists specific gene categories, aligned with Natera’s Renasight gene panel, that are actionable for CKD patients.

“KDIGO makes it clear that most CKD patients and healthcare providers would prefer to identify the underlying cause of disease, which should include a genetic diagnosis when such tests are available,” said Maggie Westemeyer, MS, CGC, and director of clinical genetic services at Natera. “This is where Natera plays a key role, providing access both to our Renasight test and to our genetic educational resources to enable guideline-recommended care.”

The guideline was released following the publication of the landmark RenaCARE study – a multisite, prospective study demonstrating the diagnostic and clinical utility of Renasight in 1,623 patients with CKD. More than 55% of all U.S. nephrologists have ordered the Renasight test.

About Renasight

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.

About Natera

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 180 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.

Forward-Looking Statements

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, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our 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.

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