Kantaro's Semi-Quantitative Antibody Test Kit Receives Health Canada Authorization Under the COVID-19 Interim Order

Rhea-AI Summary

Kantaro Biosciences, a joint venture involving RenalytixAI (RNLX) and the Mount Sinai Health System, has received Health Canada Authorization for its COVID-SeroKlir semi-quantitative antibody test kit. This kit can detect the presence and precise level of neutralizing IgG antibodies with 98.8% sensitivity and 99.6% specificity. Importantly, it is available for immediate use in Canadian laboratories without proprietary equipment. The test has already been deployed over 127,000 times on diverse populations, offering significant potential for guiding public health policies as Canada reopens.

Positive

• COVID-SeroKlir test kit achieves 98.8% sensitivity and 99.6% specificity.
• Test already utilized over 127,000 times, demonstrating reliability.
• Available immediately in Canadian laboratories without proprietary equipment.

Negative

• None.

 

- COVID-SeroKlir detects both the presence and precise level of neutralizing IgG antibodies with 98.8% sensitivity and 99.6% specificity-

-Available immediately and can be used in Canadian laboratories without proprietary equipment-

NEW YORK, June 2, 2021 /PRNewswire/ -- Kantaro Biosciences, LLC (Kantaro), a joint venture between the Mount Sinai Health System and RenalytixAI (LSE: RENS / NASDAQ: RNLX), and its commercial partner Bio-Techne Corporation (NASDAQ: TECH), have received Health Canada Authorization under the COVID-19 Interim Order for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit.

COVID-SeroKlir detects the level of neutralizing antibody levels in patients with a past infection or those vaccinated.

COVID-SeroKlir measures the presence and precise level of spike protein IgG antibodies. These are neutralizing antibodies produced as part of the immune response to COVID-19 virus exposure or generated by a vaccine and may help prevent (re-)infection. The Mount Sinai Health System in New York City developed the test's underlying technology, which has been used over 127,000 times on a highly diverse patient population.

"We are pleased to bring the COVID-SeroKlir semi-quantitative antibody test kit to Canada," said Sara Barrington, Kantaro's chief commercial officer. "COVID-SeroKlir delivers a numerical understanding of neutralizing antibody levels — not just a yes or no qualitative result — in patients with a past infection as well as those that have been vaccinated.  It is an important tool that can inform both individual healthcare decision making and public health policy while Canada reopens."

"We anticipate COVID-SeroKlir will be recognized quickly as an easily accessible, highly reliable, and reproducible test, and are prepared to manufacture at scale," said Chuck Kummeth, Bio-Techne's president and chief executive officer.

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. This precision makes the Kantaro test highly accurate, with a low potential for false results. COVID-SeroKlir is an enzyme-linked immunoassay (ELISA) that any clinical testing laboratory in Canada can use without the need for proprietary equipment. The test is available immediately for distribution.

COVID-SeroKlir has been authorized for emergency use by the U.S. Food and Drug Administration and received full CE mark authorization in the European Union.

About Kantaro Biosciences

Kantaro Biosciences, a joint venture between the Mount Sinai Health System and 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. Kantaro was named one of the World's Most Innovative Companies by Fast Company in 2021. For more information, visit www.Kantarobio.com and follow Kantaro on Twitter @kantarobio.

About Bio-Techne 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 approximately 2,600 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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SOURCE Kantaro Biosciences LLC

FAQ

What is the COVID-SeroKlir antibody test authorized by Health Canada?

The COVID-SeroKlir is a semi-quantitative SARS-CoV-2 IgG antibody test that detects the presence and level of neutralizing IgG antibodies with high accuracy.

When did Kantaro Biosciences receive Health Canada Authorization for COVID-SeroKlir?

Kantaro Biosciences received Health Canada Authorization on June 2, 2021.

What companies are involved in the development of the COVID-SeroKlir test?

The COVID-SeroKlir test is a joint initiative between Kantaro Biosciences, the Mount Sinai Health System, and Bio-Techne Corporation (NASDAQ: TECH).

What are the sensitivity and specificity rates of the COVID-SeroKlir test?

The COVID-SeroKlir test has a sensitivity of 98.8% and a specificity of 99.6%.

Can the COVID-SeroKlir test be used in Canadian laboratories?

Yes, the COVID-SeroKlir test is available for immediate use in Canadian laboratories without the need for proprietary equipment.