Natera’s Landmark RenaCARE Study Demonstrates Significant Diagnostic and Clinical Utility of Renasight™ in Chronic Kidney Disease
02 Novembro 2023 - 9:30AM
Business Wire
Study found 1 in 5 patients was positive for a
genetic cause of CKD, 1 in 2 positive patients received a new or
reclassified diagnosis, and 1 in 3 positive patients had a change
in treatment plan
Diagnostic yield and utility exceed clinical
precedents for implementation of routine genetic testing within an
at-risk population1-6
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, announced that the Journal of the American Society of
Nephrology recently published initial results from RenaCARE
(Renasight Clinical Application, Review, and Evaluation), a
multisite, real-world, prospective study assessing the frequency
and impact of genetic testing within the chronic kidney disease
(CKD) population. The study enrolled 1,623 patients with CKD across
31 community and academic medical centers. Patients were tested
with Renasight, Natera’s 385-gene kidney genetic test.
As the fastest-growing non-communicable disease in the U.S., CKD
affects more than 37 million people (approximately 1 in 7 adults).7
It adds a significant economic burden to the healthcare system,
with 23.5% of Medicare spending, $85.4 billion, related to the
management and treatment of CKD in 2020.8
CKD has a vast spectrum of underlying causes and the current
standard of care relies on basic measurements of kidney function,
imaging, and histology to inform diagnosis.9 This limited approach
has left significant gaps in the accuracy, completeness, and
specificity of patient diagnoses. Genetic testing can address many
of these limitations by identifying the underlying origin of
disease, enabling physicians to properly diagnose and stratify CKD
patients.
RenaCARE key findings
In the RenaCARE study, 20.8% of CKD patients had a positive
genetic finding. Of those, 48.8% of patients received a new or
reclassified diagnosis and 34% received information on disease
subtype. The results also showed that 90.7% of positive patients
had a change in management, including 32.9% with a change in
treatment plan.
The RenaCARE findings highlight how genetic testing can address
critical limitations in the current approach to diagnosing CKD,
across categories:
- Non-specific CKD diagnosis: 46.0%
of enrolled patients had CKD attributed to clinical categories
based on non-specific criteria, including diabetes, hypertension,
hematuria, and proteinuric disease suggestive of a primary
glomerulopathy. In many cases, these conditions are found to be
comorbidities and not the main cause of disease. Failing to further
investigate the primary cause can hinder appropriate treatment.
Within these categories, 14.7% received a positive genetic
result – of which 70.0% had a new or reclassified diagnosis, and
22.5% had a change in treatment plan.
- Undefined subtype for an existing
clinical diagnosis: 16.1% of enrolled patients were
diagnosed with cystic nephropathy, where defining a subtype can
significantly impact disease prognosis and treatment plan.
Within this category, 49.6% received a positive genetic result –
of which 79.2% received a genetic subtype confirming the clinical
presentation, and 49.2% had a change in treatment plan.
- Unknown cause of CKD: 8.1% of
patients were characterized with CKD of unknown cause, limiting the
ability to use specific treatment options. For those who screen
positive, genetic testing can identify a more targeted treatment
plan. Within this category, 18.2% received a positive genetic
result – of which 87.5% received a new diagnosis, and 23.8% had a
change in treatment plan.
- Treatment with targeted therapies:
Diagnoses based solely on clinical symptoms without detailed
genetic information limit opportunities to prescribe currently
available, targeted therapeutics or enroll patients in clinical
trials. In the study, 35.5% of patients with positive results
received a diagnosis that could make them eligible for available
therapeutics.
- Use of unnecessary and invasive
diagnostic biopsies: In many cases, genetic testing can
clarify a diagnosis and may obviate the need for invasive
procedures that carry complication risks and often still require
subsequent clarification. In the study, 19.4% of patients who
tested positive with Renasight had a biopsy prior to genetic
testing. Of those, 71.1% received a new diagnosis based on their
Renasight result, suggesting that Renasight can provide important
information to potentially avoid diagnostic biopsies in the
future.
“RenaCARE demonstrates the value of genetic testing to improve
the precision of clinical diagnoses for patients with CKD, enabling
clinicians to tailor management strategies and therapies,” said Ali
Gharavi, M.D., professor of medicine and chief of the Division of
Nephrology at New York-Presbyterian/Columbia University Irving
Medical Center, and principal investigator of the RenaCARE study.
“Our study supports the broader integration of genetic testing into
kidney care to initiate or alter management as early as
possible.”
Additional details on unmet needs within CKD and how genetic
testing can address gaps in care can be found in a white paper
published today, entitled, “Insights from RenaCARE: Genetics
Driving Precision Medicine in Kidney Disease.”
About the Renasight test
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).
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 150 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, or our expectations 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.
References
- Beck AC, Yuan H, Liao J, et al. Rate of BRCA mutation in
patients tested under NCCN genetic testing criteria. Am J Surg.
2020;219(1):145-149.
- Beitsch PD, Whitworth PW, Hughes K, et al. Underdiagnosis of
Hereditary Breast Cancer: Are Genetic Testing Guidelines a Tool or
an Obstacle?. J Clin Oncol. 2019;37(6):453-460.
- Samadder NJ, Riegert-Johnson D, Boardman L, et al. Comparison
of Universal Genetic Testing vs Guideline-Directed Targeted Testing
for Patients With Hereditary Cancer Syndrome [published correction
appears in JAMA Oncol. 2021 Feb 1;7(2):312]. JAMA Oncol.
2021;7(2):230-237.
- Ceyhan-Birsoy O, Jayakumaran G, Kemel Y, et al. Diagnostic
yield and clinical relevance of expanded genetic testing for cancer
patients. Genome Med. 2022;14(1):92.
- DeFrancesco MS, Waldman RN, Pearlstone MM, et al. Hereditary
Cancer Risk Assessment and Genetic Testing in the
Community-Practice Setting. Obstet Gynecol.
2018;132(5):1121-1129.
- Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget
stool DNA testing for colorectal-cancer screening. N Engl J Med.
2014;370(14):1287-1297.
- Centers for Disease Control and Prevention. Chronic Kidney
Disease in the United States, 2023.
https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html.
2023.
- United States Renal Data System. 2022 USRDS Annual Data Report:
Epidemiology of kidney disease in the United States, 2022.
https://usrds-adr.niddk.nih.gov/2022. 2022.
- Stevens PE and Levin A. Kidney Disease: Improving Global
Outcomes Chronic Kidney Disease Guideline Development Work Group
Members. Evaluation and management of chronic kidney disease:
synopsis of the kidney disease: improving global outcomes 2012
clinical practice guideline. Ann Intern Med.
2013;158(11):825-30.
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version on businesswire.com: https://www.businesswire.com/news/home/20231102763643/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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