NEW YORK, Jan. 23, 2019 /PRNewswire/ -- Renalytix AI
plc (LON: RENX), a developer of artificial intelligence-enabled
diagnostics for kidney disease, today announced the start of its
clinical validation study for its lead diagnostic,
KidneyIntelX™. KidneyIntelX is designed to
diagnose and improve clinical management of patients with Type II
diabetes and those of African ancestry with fast-progressing kidney
disease in an effort to curtail the estimated $114 billion
cost1 of chronic and end-stage kidney disease to
the United States healthcare
system. As outlined at the time of IPO, RenalytixAI expects to
commercially launch KidneyIntelX as a laboratory developed
test in its CLIA2 laboratory facilities to health
systems and drug developers in H2 2019.
The expanded validation study program now includes leading
investigators from Johns Hopkins Medicine, Emory University, the Icahn School of Medicine at
Mount Sinai, Northwestern University, Harvard University, and Brigham and Women's
Hospital. KidneyIntelX will use machine learning algorithms
to assess the combination of predictive blood-based biomarkers,
including sTNFR1, sTNFR2, and KIM1, in combination with electronic
health record information.
"The scale and clinical breadth of this validation provides a
rare opportunity to evaluate how AI can aid our ability to detect
fast-progressing kidney disease. KidneyIntelX will give
doctors a powerful tool to identify which individuals with kidney
disease are likely to progress to end-stage disease and should be
treated more aggressively," said Dr. Michael J. Donovan, Professor of Pathology,
Icahn School of Medicine at Mount
Sinai, and Chief Medical Officer of
RenalytixAI.
"KidneyIntelX leverages three proven blood biomarkers
validated in dozens of previous studies algorithmically combined
with features from large electronic health record databases to
identify progressive kidney disease. This approach can greatly
improve the identification of patients at highest need of
aggressive clinical intervention at any stage to slow or prevent
progression to kidney failure," said Dr. Barbara Murphy, Dean for Clinical Integration
and Population Health, and Murray M. Rosenberg Professor and Chair,
Samuel Bronfman Department of Medicine, Icahn School of Medicine at
Mount Sinai, and Chair of the
Scientific Advisory Board of RenalytixAI.
Identification of patients with chronic kidney disease (CKD) who
are at risk of, or are experiencing, rapid kidney function decline
is challenging. However, the KidneyIntelX test will
significantly improve the identification of these patients in the
early stages of CKD, thereby improving care and outcomes for these
patients through early initiation or escalation of treatment
strategies.
The clinical validation will
assess approximately 5,000 patient blood samples and
electronic health records sourced from a multi-center collaboration
including Emory University and
Mount Sinai. Participating
investigators include: Dr. Arshed Quyyumi, Director of the Emory
Clinical Cardiovascular Research Institute; Dr. Chirag Parikh3, Director of
Nephrology at Johns Hopkins; Dr.
Joseph Bonventre, Director of
Nephrology at Brigham and Women's Hospital; Dr. Susan Quaggin3, Chief of Nephrology
and Hypertension at Northwestern
University; Dr. Tamara
Isakova3, Director, Institute for Public Health
and Medicine - Center for Translational Metabolism and Health,
Associate Professor of Medicine (Nephrology and Hypertension) at
Northwestern University; and Dr.
John Quackenbush3, Chair
of Biostatistics at Harvard.
Mount Sinai investigators will
include Dr. Michael J. Donovan,
Professor of Pathology; Dr. Fadi El
Salem, Associate Professor of Pathology; Dr. Steven Coca3, Associate Chair of
Research for the Department of Medicine; and Dr. Girish Nadkarni3, Clinical Director
of The Charles Bronfman Institute for Personalized Medicine, and
Co-Director of Mount Sinai's
BioMeTM BioBank.
"I'm pleased that Mount Sinai
innovators and critical infrastructure such as
BioMeTM BioBank significantly contribute to the
advancement of diagnostics and prognostics for treating kidney
disease," said Dr. Erik Lium,
Executive Vice President of Mount Sinai Innovation Partners.
"Through this partnership with RenalytixAI and the combined
resources of major medical centers to enhance the study,
KidneyIntelX will address the needs of patients with
impaired kidney function that may lead to renal failure."
The expanded validation patient cohort increases the statistical
power of KidneyIntelX and is expected to provide additional
insight into the design of the planned clinical utility
study. Data from the clinical validation study will also be
used to support the submission of KidneyIntelX for U.S. Food
and Drug Administration review in 2019.
About Kidney Disease
Kidney disease is now
recognized as a public health epidemic affecting over 850 million
people globally. In the United
States alone, over 40 million people are classified as
having chronic kidney disease, with nearly 50 percent of
individuals with advanced (Stage IV) disease unaware of the
severity of their reduced kidney function. As a result, many
patients progress to kidney failure in an unplanned manner, ending
up having dialysis in the emergency room without ever seeing a
clinical specialist, such as a nephrologist. Every day 13 patients
die in the United States while
waiting for a kidney transplant.
About RenalytixAI
RenalytixAI is a developer of
artificial intelligence-enabled clinical diagnostic solutions for
kidney disease, one of the most common and costly chronic medical
conditions globally. The Company's solutions are being designed to
make significant improvements in kidney disease diagnosis and
prognosis, clinical care, patient stratification for drug clinical
trials, and drug target discovery. For more information, visit
renalytixai.com.
1 United States Renal Data System -
https://www.usrds.org/adrhighlights.aspx.
2 The Clinical Laboratory Improvement Act (CLIA)
program regulates laboratories that perform testing on patient
specimens in order to ensure accurate and reliable test results.
The Food and Drug Administration defines a Laboratory Developed
Test (LDT) as an in vitro diagnostic test that is manufactured and
used within a single laboratory. When a laboratory develops a test
system such as an LDT in-house without receiving FDA clearance or
approval, CLIA prohibits the release of any test results prior to
the laboratory establishing certain performance characteristics
relating to analytical validity for the use of that test system in
the laboratory's own environment.
3 Member of the RenalytixAI Advisory Board.
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SOURCE RenalytixAI