New KDIGO Guideline Supports Genetic Testing for the Majority of CKD Patients to Establish Cause of Disease
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Insights
The endorsement of genetic testing in the updated Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease by KDIGO signifies a pivotal shift in the management of CKD. This shift can potentially lead to a surge in demand for genetic testing, particularly for tests like Natera's Renasight. The study cited, RenaCARE, which showed diagnostic and clinical utility in a substantial cohort, provides empirical evidence that may increase the credibility and adoption of such tests. For stakeholders, this could mean a broadening market and increased revenue streams for companies like Natera. However, it is crucial to monitor the uptake of these guidelines in clinical practice, as the actual impact on sales and market share will depend on how quickly and widely they are adopted.
The integration of genetic testing into standard care for CKD patients aligns with a broader trend towards personalized medicine, which may improve outcomes and reduce healthcare costs in the long term. By identifying genetic causes, targeted treatments can be developed, potentially reducing the progression of the disease and the need for expensive interventions like dialysis or transplantation. However, the cost-effectiveness of widespread genetic testing as recommended by KDIGO remains to be fully evaluated. The economic implications for insurers and healthcare systems will need to be balanced against the potential benefits for patients.
Natera's positioning in the market could be substantially bolstered by the KDIGO guidelines, as the Renasight test aligns with the specific gene categories mentioned. With over half of U.S. nephrologists already using the test, market penetration is strong, but the guideline could catalyze further growth. It is essential to consider competition and the potential for other companies to develop similar or superior tests. Market dynamics, such as partnerships, insurance coverage and pricing strategies, will also play a critical role in determining the long-term success of Natera's Renasight test in the CKD genetic testing landscape.
Supports broader adoption of Natera’s RenasightTM test
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
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
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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240314228453/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
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