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Bio-Techne And Kantaro Biosciences To Launch A Quantitative Research Use Only COVID-19 Serology Test

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Bio-Techne Corporation (NASDAQ: TECH) and Mount Sinai Health System are launching the COVID-SeroIndex, a quantitative SARS-CoV-2 IgG antibody RUO kit. This test kit, part of their collaboration, will be available for research use in early August 2020. Designed as an enzyme-linked immunosorbent assay (ELISA), it measures anti-COVID-19 antibodies and their levels using two virus antigens. The technology has been tested on over 50,000 samples, aimed at supporting vaccine development.

Positive
  • Launch of COVID-SeroIndex test kit for antibody measurement.
  • Test kit leverages technology tested on over 50,000 samples.
  • High accuracy could accelerate COVID-19 vaccine development.
Negative
  • Competing COVID-19 testing products may affect market acceptance.
  • Regulatory approvals remain a hurdle for product introduction.

MINNEAPOLIS and NEW YORK, Aug. 3, 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 the anticipated launch of the COVID-SeroIndex, a Kantaro Quantitative SARS-CoV-2 IgG Antibody RUO kit. Bio-Techne and Kantaro will leverage a joint commercialization and distribution team to support rapid distribution of the assay to the vaccine development community.  The COVID-SeroIndex test kit is expected to be available for research use in early August.  

The COVID-SeroIndex test kit is an enzyme-linked immunosorbent assay, or ELISA, 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. The underlying technology was created by Mount Sinai's internationally recognized team of virologists and pathologists and has been tested on over 50,000 patient samples.

"The launch of a RUO version of the COVID-19 serology test brings to the research community what we believe is the highest quality SARS-CoV-2 antibody assay available," commented Dave Eansor, Bio-Techne's Protein Sciences Segment President.  "The assay supports the life cycle of COVID-19 vaccine development, providing researchers with an objective way of measuring antibody titer."

"The COVID-SeroIndex test kit is a natural extension of the previously announced Bio-Techne and Kantaro partnership," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne.  "We are hopeful that this assay can accelerate the near-term launch of a successful COVID-19 vaccine due to its high level of accuracy and robustness."

"Mount Sinai has invested heavily in this technology and in leading research and clinical care for COVID-19. We recognized the need to deliver a high-quality, accurate assay and there has been immense development and application of the underlying technology for this test at Mount Sinai," said Erik Lium, PhD, Executive Vice President and Chief Commercial Innovation Officer at Mount Sinai. "We're thrilled to launch this additional research assay with Bio-Techne, continue building our understanding of COVID-19, and make this tool available globally to researchers."

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 2,300 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 in partnership with RenalytixAI, 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.

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

Bio-Techne

 

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SOURCE Bio-Techne Corporation

FAQ

What is the COVID-SeroIndex test kit launched by Bio-Techne (TECH) and Mount Sinai Health System?

The COVID-SeroIndex is a quantitative SARS-CoV-2 IgG antibody RUO kit designed to measure the presence and levels of anti-COVID-19 antibodies.

When will the COVID-SeroIndex test kit be available for use?

The COVID-SeroIndex test kit is expected to be available for research use in early August 2020.

How has the COVID-SeroIndex test been validated?

The test has been tested on over 50,000 patient samples, ensuring its reliability and accuracy.

What technology underlies the COVID-SeroIndex test kit?

The test utilizes two virus antigens: the full-length spike protein and its receptor binding domain.

What are the potential challenges for Bio-Techne (TECH) regarding the COVID-SeroIndex kit?

Challenges include obtaining regulatory approvals and facing competition from other COVID-19 testing products.

Bio-Techne Corp.

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