NEW YORK, Nov. 25, 2020 /PRNewswire/ -- 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.
Measuring IgG antibody levels with COVID-SeroKlir can inform
healthcare decision-making and assess vaccine response.
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.
About COVID-SeroKlir
COVID-SeroKlir is a
semi-quantitative SARS-CoV-2 IgG antibody test kit. It detects both
the presence and the level of IgG antibodies without the need
for proprietary equipment. COVID-SeroKlir has 98.8% sensitivity and
99.6% specificity resulting from a two-step process that
detects antibodies against two virus antigens, the full-length
spike protein and its receptor-binding domain. Mount Sinai developed the test's underlying
technology, which has been used over 80,000 times on a highly
diverse patient population. COVID-SeroKlir received Emergency
Use Authorization by the FDA and CE marking for use in Europe.
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-Techne
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
Renalytix AI 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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SOURCE Kantaro Biosciences LLC