TIDMEKF
RNS Number : 4029D
EKF Diagnostics Holdings PLC
28 October 2020
This announcement contains inside information
for the purposes of Article 7 of Regulation (EU) No 596/2014
(MAR)
EKF and Kantaro Biosciences partner to market quantitative COVID
antibody testing in UK and Europe
EKF to distribute Kantaro COVID-SeroKlir and COVID-SeroIndex
quantitative COVID antibody tests in UK and Europe
Kantaro antibody testing technology supports assessment of
immunity to COVID and vaccine development
EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed
point-of-care business, announces a two year marketing and
distribution agreement with Kantaro Biosciences, LLC ("Kantaro") ,
a joint venture between the Mount Sinai Health System and
RenalytixAI plc (LSE: RENX / NASDAQ: RNLX), and manufacturing
partner Bio-Techne Corporation (NASDAQ: TECH) .
EKF will have exclusive rights to market and distribute
COVID-SeroKlir , Kantaro's quantitative SARS-CoV-2 IgG antibody
test kit in the UK and Germany and non-exclusive rights in Europe.
For the research market, EKF will have non-exclusive rights to
distribute COVID-SeroIndex across the UK and Europe. Kantaro
antibody testing technology supports assessment of immunity to
COVID, which is a potentially critical component to maintaining the
flow of commerce locally and internationally, and to understanding
the effectiveness of vaccination programs.
The agreement follows the receipt of the CE Mark certification
approving the use of COVID-SeroKlir and COVID-SeroIndex for
detecting the presence and the precise titer (level) of IgG
antibodies. Measuring the level of neutralizing antibodies in
addition to other antibodies a person produces as part of their
immune response to COVID-19 virus exposure provides important
information in assessing any likely protection against future
re-infection.
Antibody tests are also an important component of a general
health check to determine if a patient has had past COVID-19
infections, with or without symptoms, including when there has not
been a positive test measuring the presence of the virus . COVID-19
has been linked to an increased risk of potentially
life-threatening complications, including cardiovascular, kidney
and lung disease.
"EKF's robust footprint in regions affected by COVID-19 will
allow us to get quantitative testing to patients and doctors as
quickly as possible to help them assess immunity decision - making
at both the individual level and for population - wide policy
making," said Sara Barrington, Kantaro's Chief Commercial Officer.
"We believe that quantitative antibody testing will help patients
and businesses take control of their healthcare choices during this
uncertain time."
Julian Baines, CEO of EKF, said: "EKF can drive rapid
availability of COVID-SeroKlir kits and COVID-SeroIndex to a broad
range of laboratories for immediate operation without needing
specialized testing equipment. Quantitative testing can provide
important support for determining public health strategies,
informing healthcare decision making, and potentially verifying the
effectiveness of vaccines as they become available."
COVID-SeroKlir and COVID-SeroIndex ha ve demonstrated 97.8%
sensitivity and 99.6% specificity for detecting COVID-19 specific
IgG antibodies. Its high precision results from a two-step process
that utilizes two virus antigens: the full-length spike protein and
its receptor-binding domain (RBD). Both the COVID-SeroIndex and the
COVID-SeroKlir tests are enzyme-linked immunoassays (ELISA), which
means any clinical testing laboratory can use it in the EU without
the need for proprietary equipment. The configuration of Kantaro's
COVID-SeroIndex antibody testing kits is designed to assist
research efforts and support policy making both at the EU level and
worldwide.
The Kantaro antibody testing technology is based on research
performed at the Icahn School of Medicine at Mount Sinai in New
York City. The Mount Sinai technology has already been used in a
highly diverse population of over 75,000 patient samples to screen
for convalescent plasma donors and determine past infections in the
clinical assessment of potentially life-threatening complications
from COVID-19, including lung, kidney and cardiovascular
disease.
EKF Diagnostics Holdings plc www.ekfdiagnostics.com
Christopher Mills, Non-executive Chairman Tel: +44 (0) 29 2071 0570
Julian Baines, CEO
Richard Evans, FD & COO
N+1 Singer Tel: 020 7496 3000
Aubrey Powell / George Tzimas (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Walbrook PR Limited Tel: +44 (0) 20 7933 8780 or ekf@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: +44 (0) 7980 541 893 / +44 (0) 7584
391 303
About EKF Diagnostics Holdings plc ( www.ekfdiagnostics.com
)
EKF is a leading point-of-care diagnostics and central
laboratory assay manufacturer with an estimated 80,000 hemoglobin,
hematocrit, HbA1c, glucose and lactate analyzers in regular use
across more than 100 countries. EKF specializes in developing tests
for use in anemia and diabetes diagnosis and management, as well as
providing a portfolio of reagents for use in clinical chemistry
analyzers.
About Kantaro Biosciences
Kantaro Biosciences ("Kantaro"), a Mount Sinai Health System
venture, is dedicated to ensuring that high-quality diagnostic
tests for critical health challenges are accessible. The company
provides rigorous, results-driven and reproducible diagnostics to
advance the care and well-being of people, communities and society.
Kantaro specializes in the rapid scale-up of groundbreaking
diagnostic innovations and the creation of partnerships to bring
these crucial technologies to market. For more information, visit
www.kantarobio.com and follow Kantaro on Twitter @kantarobio.
About Bio-Techn e Corporation
Bio-Techne Corporation (NASDAQ: TECH ) is a global life sciences
company providing innovative tools and bioactive reagents for the
research and clinical diagnostic communities. Bio-Techne products
assist scientific investigations into biological processes and the
nature and progress of specific diseases. They aid in drug
discovery efforts and provide the means for accurate clinical tests
and diagnoses. With thousands of products in its portfolio,
Bio-Techne generated approximately $739 million in net sales in
fiscal 2020 and has over 2,300 employees worldwide. For more
information on Bio-Techne and its brands, please visit
www.bio-techne.com .
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest
academic medical system, encompassing eight hospitals, a leading
medical school, and a vast network of ambulatory practices
throughout the greater New York region. Mount Sinai is a national
and international source of unrivaled education, translational
research and discovery, and collaborative clinical leadership
ensuring that we deliver the highest quality care-from prevention
to treatment of the most serious and complex human diseases. The
Health System includes more than 7,200 physicians and features a
robust and continually expanding network of multispecialty
services, including more than 400 ambulatory practice locations
throughout the five boroughs of New York City, Westchester, and
Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News
& World Report's "Honor Roll" of the Top 20 Best Hospitals in
the country and the Icahn School of Medicine as one of the Top 20
Best Medical Schools in country. Mount Sinai Health System
hospitals are consistently ranked regionally by specialty and our
physicians are in the top 1% of all physicians nationally by U.S.
News & World Report.
For more information, visit https://www.mountsinai.org or find
Mount Sinai on Facebook , Twitter and YouTube .
About Renalytix AI plc
RenalytixAI is a developer of artificial intelligence-enabled
clinical in vitro diagnostic solutions for kidney disease, one of
the most common and costly chronic medical conditions globally. The
Company's products are being designed to make significant
improvements in kidney disease diagnosis, transplant management,
clinical care, patient stratification for drug clinical trials, and
drug target discovery. For more information, visit renalytixai.com
.
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