TIDMEKF
EKF Diagnostics Holdings PLC
26 November 2020
EKF Diagnostics Holdings plc
("EKF", the "Company" or the "Group")
COVID-SeroKlir receives FDA Emergency Use Authorisation
EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed
point-of-care business, welcomes the news from its partner Kantaro
Biosciences, LLC ("Kantaro") yesterday c onfirm ing that it had
received Emergency Use Authorization (EUA) from the U.S. Food and
Drug Administration (FDA) for COVID-SeroKlir, its semi-quantitative
SARS-CoV-2 IgG antibody test kit.
EKF has exclusive rights to market and distribute
COVID-SeroKlir, a quantitative SARS-CoV-2 IgG antibody test kit, in
the UK and Germany and non-exclusive rights in Europe. The
statement from Kantaro is reproduced in full below:
Kantaro Receives FDA Emergency Use Authorization for
Semi-Quantitative COVID-19 Antibody Test Kit that Detects the
Presence and Level of SARS-CoV-2 IgG Antibodies
COVID-SeroKlir is a high-performance semi-quantitative antibody
test kit based on Mount Sinai technology, with a broad range of
applications in the fight against COVID-19
The Kantaro test is being manufactured at scale and immediately
available in the U.S.
NEW YORK, November 24, 2020 - Kantaro Biosciences, LLC, a joint
venture between the Mount Sinai Health System and RenalytixAI
(NASDAQ: RNLX), has received Emergency Use Authorization (EUA) from
the U.S. Food and Drug Administration (FDA) for COVID-SeroKlir, its
semi-quantitative SARS-CoV-2 IgG antibody test kit. Unlike other
antibody tests, COVID-SeroKlir determines the presence and precise
level of IgG antibodies and has a broad range of applications in
the fight against COVID-19. Through a commercial partnership with
Bio-Techne Corporation (NASDAQ: TECH) the test kits are being
manufactured at scale with a capacity of up to 10 million tests per
month and the ability to scale up.
COVID-SeroKlir has demonstrated 98.8% sensitivity and 99.6%
specificity for detecting SARS-CoV-2 specific IgG antibodies
against two virus antigens, the full-length spike protein and its
receptor-binding domain. COVID-SeroKlir is a two-step enzyme-linked
immunosorbent assay (ELISA) and can be used by any CLIA-certified
laboratory without the need for proprietary equipment. The Kantaro
test kit received CE mark in October 2020 and is available in 29
countries in Europe.
"COVID-SeroKlir is based on Mount Sinai technology that was
developed at the height of the COVID-19 pandemic in New York City,"
said Sara Barrington, Kantaro's chief commercial officer. "It is a
high performing test that quantifies antibody levels for
individuals, which medical professionals and policymakers alike can
trust. Having a numerical understanding of antibody levels can be
especially powerful for patients, enabling them to take control of
their health and enjoy some peace of mind during these uncertain
times."
Measuring IgG antibody levels with COVID-SeroKlir can inform
healthcare decision-making and public health strategies, as well as
assess vaccine response. Semi-quantitative antibody testing is also
an essential component of a general health check to determine past
COVID-19 infections. An increased risk of potentially
life-threatening complications, including lung, kidney, and
cardiovascular disease, has been linked to COVID-19.
"Widespread testing is critical in the fight against COVID-19.
With this EUA in hand, we are ready to immediately supply this
best-in-class serologic assay to clinicians across the U.S.," said
Chuck Kummeth, president and chief executive officer of Bio-Techne
Corporation. "Manufacturing will begin with a capacity of up to 10
million tests per month. We anticipate that COVID-SeroKlir will
play an increasingly important role in the decision making of
healthcare providers and policymakers and are prepared to scale up
to meet additional demand."
Mount Sinai developed the underlying technology in
COVID-SeroKlir, which has been used and validated in a highly
diverse population of over 80,000 patient samples. The
peer-reviewed journal Science recently published five-month data
from an ongoing Mount Sinai study using the underlying technology.
Data show that most people who have had COVID-19 mount a robust
antibody response that remains relatively stable for at least five
months following infection. This antibody response correlates with
the body's ability to neutralize SARS-CoV-2.
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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