RCS - EKF Diagnostics Hldg - COVID-SeroKlir - FDA Emergency Use Authorisation

EKF Diagnostics HoldingsAnnouncement

26/11/2020 07:00

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RNS Number : 5351G  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 confirming 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
(https://science.sciencemag.org/content/early/2020/10/27/science.abd7728)
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 (http://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 (mailto: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
(http://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 (http://www.kantarobio.com/)  and follow Kantaro on
Twitter @kantarobio.

 

About Bio-Techne Corporation

Bio-Techne Corporation (NASDAQ: TECH
(https://www.prnewswire.com/news-releases/bio-techne-and-kantaro-biosciences-to-launch-a-quantitative-research-use-only-covid-19-serology-test-301104261.html#financial-modal)
) 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 (http://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
(https://www.mountsinai.org/) or find Mount Sinai on Facebook
(https://www.facebook.com/mountsinainyc) , Twitter
(https://twitter.com/mountsinainyc) and YouTube
(https://www.youtube.com/mountsinainy) .

 

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
(https://c212.net/c/link/?t=0&l=en&o=2873520-1&h=3601859824&u=https%3A%2F%2Frenalytixai.com%2F&a=renalytixai.com)
.

 

 

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