MINNEAPOLIS and NEW YORK, May 19,
2020 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:TECH)
and the Mount Sinai Health System in New York, through its commercial affiliate
Kantaro Biosciences LLC (Kantaro), today announced a partnership to
initiate scaled manufacturing and distribution of testing kits
based on the Mount Sinai-developed
COVID-19 serology test. Kantaro Biosciences is a joint venture
between Mount Sinai Health System ("Mount
Sinai") and Renalytix AI (LSE: RENX) formed exclusively to
ensure that diagnostic tests for critical health challenges are
accessible to all. The Mount Sinai COVID-19 serology test was one
of the first widely published serology tests in the United States and has gained recognition
as a trusted, high-performing assay and comparator for subsequent
COVID-19 serology tests. Kantaro has partnered with Bio-Techne to
develop a test kit based on the Mount
Sinai test and to scale up, manufacture, sell and distribute
these kits. Initial kit production capacity is expected to enable
laboratories to conduct in excess of 10 million tests monthly in
July, scaling to higher capacity in subsequent months. The
two companies have formed a joint commercialization and
distribution team to support rapid distribution of the assay.
Mount Sinai was issued an
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA) for clinical testing in its CLIA certified
laboratory on April
15th. Based on this success, Bio-Techne and
Mount Sinai have partnered to
develop high-quality production test kits, based upon the
Mount Sinai test, which can be
manufactured and distributed globally at scale. Kantaro will
lead regulatory processes with the intention of submitting the
scaled assay for FDA EUA review in May. Kit shipments are
expected to begin immediately following the receipt of FDA
regulatory authorization.
The IgG antibody test kit, an enzyme-linked immunosorbent assay
or ELISA, is designed to measure the presence or absence of
anti-COVID-19 antibodies in addition to measuring the titer (level)
of antibodies a person has produced. It utilizes not one, but
two virus antigens, the full-length Spike protein, and its Receptor
Binding Domain, which is necessary for viral entry into cells, and
is potentially linked with neutralization. The test kit will
use a simple patient blood draw and is designed to be easily run by
any laboratory in the world without costly proprietary
equipment. The technology underlying the diagnostic test was
created by internationally recognized virology and pathology teams
from the Icahn School of Medicine at Mount Sinai.
In a recent comparison of EUA tests published by the FDA (link),
which assumed a 5% incidence of COVID-19 in the population, the
"Mount Sinai Hospital Clinical Laboratory COVID-19 ELISA Antibody
Test" was reported to show a Positive Predictive Value (the
probability of disease if the test is positive) of 100% and a
Negative Predictive Value (the probability of no disease if the
test is negative) of 99.6%. Bio-Techne and Kantaro are in the
process of validating the scaled assay and expect the data to
confirm similar results.
"Combining Mount Sinai's strengths in disease management,
patient monitoring and clinical study design with Bio-Techne's
capabilities as a fully integrated, world leading ELISA developer
and manufacturer, allows us to co-develop and validate what we
believe will be the highest quality and highest utility assay for
COVID-19 in the world," commented Dave
Eansor, Bio-Techne's Protein Sciences Segment
President. "The assay not only identifies individuals with
prior exposure to the COVID-19 virus; the two step test is designed
to minimize false negative and false positive results while
delivering valuable, quantitative information regarding the
immunity state of previously infected people."
"We are extremely excited to partner with Kantaro and
Mount Sinai to launch what we
believe will be a gold standard serology test for COVID-19," said
Chuck Kummeth, President and Chief
Executive Officer of Bio-Techne. "The Bio-Techne,
Mount Sinai and Kantaro teams are
working around the clock to develop this test, and we are on track
to achieve in approximately eight weeks what would typically take
18 months or more. As the world leader in ELISA assays,
Bio-Techne has substantial capacity and the ability to scale
production levels to support much of our nation's needs. We
look forward to providing the world with critical information
related to past exposure to the virus."
"Antibody testing will be critical to providing patients and
governments the essential information they need to help the world
economies reopen and begin to recover from COVID-19," said
Florian Krammer, PhD, Professor of
Microbiology at Icahn School of Medicine. "Through Kantaro's
partnership with Bio-Techne, we look forward to bringing this
extremely high-quality test to every corner of the globe, so that
COVID-19 can be monitored and isolated."
The original Mount Sinai assay
has been performed on more than 30,000 patient samples.
Mount Sinai is studying the use of
the technology to measure antibody titer in previously infected
individuals, to support vaccine development, and to help evaluate
emerging immunotherapies.
Forward Looking Statements:
Bio-Techne's press releases may contain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act. Such statements involve risks and
uncertainties that may affect the actual results of operations. The
following important factors, among others, have affected and, in
the future, could affect Bio-Techne's actual
results: the market for and introduction, acceptance and
performance of new products, obtaining the appropriate regulatory
approvals, the impact of the growing number of producers of
biotechnology products, including COVID-19 testing products, and
related price competition, general economic conditions,
manufacturing and supply chain disruptions, and the potential
impact of COVID-19 on our operations or financial results.
For additional information concerning these and other such
factors, see the section titled "Risk Factors" in
Bio-Techne's annual report on Form 10-K and quarterly
reports on Form 10-Q as filed with the Securities and Exchange
Commission. Bio-Techne undertakes no obligation to update or revise
any forward-looking statements made in its press releases due to
new information or future events. Investors are cautioned not to
place undue emphasis on these statements.
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 $714
million in net sales in fiscal 2019 and has over 2,200
employees worldwide. For more information on Bio-Techne and its
brands, please visit www.bio-techne.com.
Contact:
David Clair, Senior Director,
Investor Relations & Corporate Development
david.clair@bio-techne.com
About Kantaro Biosciences
Kantaro Biosciences ("Kantaro"), a Mount Sinai Health System
venture, is dedicated to ensuring that diagnostic tests for
critical health challenges are accessible to all. The company
provides academically rigorous, validated and results-driven
diagnostics to advance the wellbeing of people, communities and
society. Kantaro specializes in the rapid scaleup of groundbreaking
diagnostic innovations and the creation of partnerships to bring
these crucial technologies to market. The company is majority owned
and controlled by Mount Sinai. For
more information, visit www.kantarobio.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 Bio-Techne Corporation