New KDIGO Guideline Supports Genetic Testing for the Majority of CKD Patients to Establish Cause of Disease
14 March 2024 - 11:00PM
Business Wire
Supports broader adoption of Natera’s
RenasightTM 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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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
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