Skip to main content

OraSure’s ORAcollect®·RNA Device Included in EUA Granted to Quadrant Biosciences Inc. for COVID-19 Test

Written by Customer Service on . Posted in Public Companies.

BETHLEHEM, Pa., Sept. 24, 2020 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced that its ORAcollect®·RNA (OR-100) saliva collection device has been included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to Quadrant Biosciences Inc. for a COVID-19 laboratory test. Under the EUA, the ORAcollect®·RNA (OR-100) device can be used to collect saliva samples from individuals suspected of COVID-19 infection by a healthcare professional. This is the sixth EUA to include a collection device from the Company’s DNA Genotek subsidiary and the first to exclusively utilize a saliva collection method.
Quadrant’s Clarifi COVID-19 Test Kit, developed in partnership with SUNY Upstate Medical University, leverages the company’s established expertise in RNA-based diagnostics. The non-invasive, and easy to administer, saliva swab test determines the presence or absence of SARS-CoV-2 viral RNA, and will be immediately available for use by high-complexity clinical laboratories serving patients through physicians’ offices, urgent care clinics and hospitals.“Expansion of testing is a key to helping slow the spread of COVID-19 and safely reopen economies. That’s why DNA Genotek is leveraging our expertise in non-invasive sample collection to provide more devices to more testing facilities, to help check millions of people around the world for COVID-19,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. “DNA Genotek, now with six EUAs that include our collection kits, has emerged as a leading company helping to detect the virus.”“We are thrilled that the FDA has issued the Clarifi COVID-19 test EUA approval for use in the diagnosis of COVID-19,” said Richard Uhlig, Founder and CEO of Quadrant Biosciences. “The coronavirus has had a devastating effect on health and welfare worldwide, so it is extremely gratifying for us to take the expertise we have gained working on RNA diagnostic tests for other health conditions, such as autism spectrum disorder and Parkinson’s disease, and apply that expertise to the development of this critically important test.”About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, CoreBiome (now operating under the Diversigen brand), UrSure and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., focuses on providing high-quality biological sample collection products and end-to-end services for human genomics and microbiome applications. The Company’s Oragene®•Dx and ORAcollect®•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.