NEW YORK, July 9, 2019 /PRNewswire/ -- Renalytix AI plc
(AIM: RENX), a developer of artificial intelligence-enabled
clinical diagnostics for kidney disease, announced today positive
interim analysis of data from the KidneyIntelX™
expanded validation study. The results show that in a multi-center
cohort of Type 2 diabetes patients, the KidneyIntelX
algorithm has met or exceeded required performance targets for
identifying those patients experiencing rapid kidney function
decline (RKFD)1 and patients who eventually progressed
to kidney failure and/or dialysis. The expanded validation program
data will support the ongoing regulatory process with the Food and
Drug Administration ("FDA") under Breakthrough Device designation,
which was announced May 2,
2019.
"We have now completed the complex process of integrating
electronic health record data and our proprietary blood biomarker
measurements from over 3,000 patients with Type 2 diabetes from
three independent, diverse population groups," said Fergus Fleming, Chief Technology Officer of
RenalytixAI. "KidneyIntelX continues to demonstrate
significant performance improvements over current diagnostic
standards and now in a multi-center environment."
Initial performance targets, as outlined in a published study
and publicly announced by RenalytixAI on April 1, 2019, illustrated that the
KidneyIntelX machine learning algorithm significantly
increased the ability to predict which patients went on to
experience RKFD versus currently used diagnostic methods.
Similarly, in the expanded validation study population, the
positive predictive value ("PPV") of KidneyIntelX for RFKD
in the Type 2 diabetes population exceeded 50 percent in those
patients who were in the highest 15 percent of the risk
distribution, and a negative predictive value of greater than 95
percent for patients unlikely to experience RKFD. This compares to
a PPV of approximately 30 percent for standard of care methods. In
addition, when the performance target was analyzed for the clinical
end-point of kidney failure within five years, in the interim
results from the expanded validation study the PPV improved
further.
Identifying high-risk patients more accurately and earlier can
enable optimized clinical management and therapeutic options to
slow kidney disease progression and help reduce the overall risk of
developing end-stage kidney disease and unplanned or "crash"
dialysis. In the United States
healthcare system alone, these costs are estimated at $114 billion per year.
The Company announced on January 23,
2019 the initiation of this validation study series to
assess blood samples and electronic health records from patients
with both Type 2 diabetes and patients of African ancestry. The
Company intends to release further data updates in the near term
including data relating to the multi-center, African ancestry
patient cohort analyzed by KidneyIntelX with the addition of
a high-risk inherited gene known as APOL1 into the
algorithm.
The Company continues to work closely with FDA under
Breakthrough Device designation to test KidneyIntelX in a
final independent cohort of subjects that will form the basis for
consideration in the ongoing regulatory approval process.
RenalytixAI intends to provide further updates on this process in
the near term as appropriate.
The KidneyIntelX artificial intelligence-enabled in
vitro diagnostic uses a machine learning algorithm to assess
results from proprietary blood biomarkers in combination with
information from a patient's electronic health record, to generate
an RKFD score. The expanded validation study program includes
stored patient plasma samples and corresponding electronic health
record features collected from three leading academic medical
centers: Emory University, the Icahn
School of Medicine at Mount Sinai
and the University of Pennsylvania.
RenalytixAI expects to commercially launch KidneyIntelX in
the United States in H2
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.
Notes
1. Rapid kidney function decline or RKFD is
defined as a change in kidney function (glomerular filtration rate)
of at least 5ml/min/1.73m2/year
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SOURCE RenalytixAI