TIDMEKF
RNS Number : 7601P
EKF Diagnostics Holdings PLC
31 May 2018
EKF Diagnostics Holdings plc
("EKF", the "Company")
Exclusive worldwide licence and collaboration agreement with
Icahn School of Medicine at Mount Sinai, NY
Renalytix AI PLC to develop Artificial Intelligence
solutions
for early identification and management of kidney disease
EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed
point-of-care business, announces that its subsidiary, Renalytix AI
PLC, has signed an exclusive license and collaboration agreement
with the Icahn School of Medicine at Mount Sinai in New York, USA,
("Mount Sinai") (the "Agreement").
As previously announced at the time of the Company's most recent
results, EKF is in the process of spinning out its solid tumour
necrosis factor ("sTNFR") biomarker technology into Renalytix AI
Inc ("Renalytix AI"), a separate entity, registered in the USA. The
Directors believe the sTNFR biomarker technology has the potential
to deliver significant upside value for EKF shareholders. The
Directors of Renalytix AI PLC are exploring funding options for
that business, including equity funding. Existing EKF shareholders
would have a continuing interest in the Renalytix AI business and
the opportunity to participate in any separate equity funding of
Renalytix AI PLC.
Key highlights of the Agreement
-- sTNFR biomarkers and AI technology deployed against
de-identified clinical data from Mount Sinai's 3 million patient
electronic data warehouse and 43,000 patient records from the
BioMe(TM) BioBank repository(1)
-- First pre-market approved product expected to launch in the
US in H1 2019 for improved disease detection / care management,
with the intention of gaining Food and Drug Administration ("FDA")
approval in 2020
-- Kidney disease affects an estimated 120 million people in the
US and EU (c. 12% of the population), with 90% of these unaware
they are at risk
-- $98bn in costs to Medicare attributed to preventable chronic
kidney disease and dialysis annually
Under the Agreement, Mount Sinai will be able to use EKF's sTNFR
biomarkers alongside artificial intelligence ("AI") technology to
mine patient data and quickly identify which candidates are at the
highest risk of progressive Diabetic Kidney Disease ("DKD")
potentially leading to End Stage Renal Disease ("ESRD"), a disease
which costs the US healthcare system nearly $100 billion
annually.
Mount Sinai is one of the largest integrated healthcare systems
in the US, caring for diabetics and patients of African ancestry,
the two major population groups most affected by kidney disease and
dialysis. As part of the agreement, Renalytix AI PLC will look to
leverage de-identified clinical data from Mount Sinai's substantial
data warehouse containing over 3,000,000 patient health records and
its 43,000 patient BioMe(TM) BioBank repository to create an
advanced learning system to monitor and flag patients at risk for
kidney disease and unplanned "crashes" requiring costly dialysis
treatment.
Plans for Renalytix AI
Subject to funding, the first product is expected to launch in
H1 2019, targeting the significant costs to the US Medicare system
of preventable dialysis and chronic kidney disease. Additional
major US based healthcare systems are also expected to participate
in clinical utility data collection and commercial launch.
Upon successful completion of clinical validation in late 2018,
Mount Sinai has agreed to participate in testing several thousand
at-risk patients in an Institutional Review Board-approved clinical
utility study in 2019, at an estimated cost of $6 million.
Renalytix AI will prepare its initial AI applications for FDA
review and expanded validation through collaborations with leading
academic medical centres, pharmaceutical and patient advocacy
organisations in the United States and Europe with work planned to
begin this year, aiming for FDA approval in 2020.
Barbara Murphy, MD, Dean for Clinical Integration and Population
Health and Chair of the Department of Medicine at the Icahn School
of Medicine at Mount Sinai, and Chair of the Renalytix AI
Scientific Advisory Board said: "Our ability to apply the power of
artificial intelligence against such a deep repository of data and
disease specific biomarkers has the potential to change the game
for all of our diabetic patients and other populations at risk for
kidney disease."
Julian Baines, Chief Executive Officer of EKF and Executive
Chairman of Renalytix AI, added: "This is a significant partnership
for Renalytix AI with one of the largest hospital groups in the
United States. Coupling its technology with the Mount Sinai patient
database will improve patient care in End Stage Renal Disease, a
significant unmet medical need. The fact that so many patients on
dialysis have never seen a specialist has to change, both from a
patient care and cost perspective. I believe that this partnership
will result in Renalytix AI being leaders in the field of kidney
care, alongside Mount Sinai."
(1) The BioMe biobank is an electronic medical record
(EMR)-linked biobank that enables researchers to conduct genetic,
epidemiologic, molecular, and genomic studies quickly and
efficiently on large collections of research specimens linked with
medical information.
Enquiries:
EKF Diagnostics Holdings plc www.ekfdiagnostics.com
Christopher Mills, Non-Executive Tel: 029 2071 0570
Chairman
Julian Baines, CEO
Richard Evans, FD & COO
N+1 Singer (Nomad & Broker) Tel: 020 7496 3000
Aubrey Powell / Shaun Dobson
Walbrook PR Limited Tel: 020 7933 8780 or ekf@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: 07980 541 893 / 07584 391 303
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest
integrated delivery system encompassing seven hospital campuses, a
leading medical school, and a vast network of ambulatory practices
throughout the greater New York region. Mount Sinai's vision is to
produce the safest care, the highest quality, the highest
satisfaction, the best access and the best value of any health
system in the nation.
The System includes approximately 7,100 primary and specialty
care physicians; 10 joint-venture ambulatory surgery centers; more
than 140 ambulatory practices throughout the five boroughs of New
York City, Westchester, Long Island, and Florida; and 31 affiliated
community health centers. The Icahn School of Medicine is one of 3
medical schools that have earned distinction by multiple
indicators: ranked in the top 20 by U.S. News & World Report's
"Best Medical Schools", aligned with a U.S. News & World
Report's "Honor Roll" Hospital, No. 13 in the nation for National
Institutes of Health funding, and among the top 10 most innovative
research institutions as ranked by the journal Nature in its Nature
Innovation Index. This reflects a special level of excellence in
education, clinical practice, and research. The Mount Sinai
Hospital is ranked No. 18 on U.S. News & World Report's "Honor
Roll" of top U.S. hospitals; it is one of the nation's top 20
hospitals in Cardiology/Heart Surgery, Diabetes/Endocrinology,
Gastroenterology/GI Surgery, Geriatrics, Nephrology, and
Neurology/Neurosurgery, and in the top 50 in four other specialties
in the 2017-2018 "Best Hospitals" issue. Mount Sinai's Kravis
Children's Hospital also is ranked in six out of ten pediatric
specialties by U.S. News & World Report. The New York Eye and
Ear Infirmary of Mount Sinai is ranked 12th nationally for
Ophthalmology and 50th for Ear, Nose, and Throat, while Mount Sinai
Beth Israel, Mount Sinai St. Luke's and Mount Sinai West are ranked
regionally.
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END
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