DNA Genotek Gets FDA Emergency Use Authorization for Saliva Collection Devices Nov 02, 2020 | staff reporter
NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for saliva collection devices used for SARS-CoV-2 testing that was developed by DNA Genotek.
The ORAcollect RNA ORE-100 and ORAcollect RNA OR-100 devices are designed for the collection, stabilization, transport of saliva specimens suspected of containing SARS-CoV-2 RNA. They are intended for use as a component of a third-party SAR-CoV-2 test or home/self-collection kit and are not intended for sale directly to patients.
Both devices are identical except for model numbers and labeling, according to the FDA.
DNA Genotek is a subsidiary of Bethlehem, Pennsylvania-based OraSure Technologies.
Authorized SARS-CoV-2 tests that use the OraCollect devices include Quadrant Biosciences' Clarifi COVID-19 Test Kit.
A PR issued by OSUR today about the ORAcollect EUA mentioned above:
OraSure’s DNA Genotek Subsidiary Receives FDA Emergency Use Authorization for its ORAcollect®·RNA Saliva Collection Device for SARS CoV-2
Second FDA EUA for the Subsidiary’s Saliva Collection Devices
BETHLEHEM, Pa., Nov. 03, 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 its DNA Genotek subsidiary has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the use of the ORAcollect ® ·RNA (OR/ORE-100) saliva collection device for the collection, stabilization and transport of saliva specimens suspected of containing SARS-CoV-2 RNA. This is the second FDA EUA that DNA Genotek has received for its saliva collection devices.
Like the EUA DNA Genotek recently obtained for OMNIgene ® ·ORAL (OM/OME-505), this EUA allows for the unsupervised use of the device at-home or in a healthcare setting when used as a component of an authorized or cleared self-collection kit. This means it can be part of a kit that is authorized under its own EUA for use by an individual to collect saliva specimens at home.
“Accessible and accurate testing programs that include a non-invasive, saliva-based collection option will be essential throughout the duration of the COVID-19 pandemic,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. “This second EUA gives our customers additional non-invasive options for SARS CoV-2 sample collection. Saliva sample collection is quick, painless, non-invasive and requires less human contact both minimizing the need for PPE and reducing exposure to potentially infected patients.”
The ORAcollect·RNA collection device is an important component of molecular/PCR tests as laboratories are able to use it as the saliva sample collection method for their COVID-19 tests.
In addition to molecular sample collection devices for lab-based molecular/PCR COVID-19 testing from its DNA Genotek subsidiary, OraSure is also developing a lab-based oral fluid SARS-CoV-2 antibody test, and a rapid antigen self-test for COVID-19.
The ORAcollect·RNA and OMNIgene·ORAL sample collection devices have not been FDA cleared or approved; the devices have been authorized by FDA under an EUA. The ORAcollect·RNA and OMNIgene·ORAL sample collection devices have been authorized only to collect, stabilize, and maintain during transport, saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA), not for any other viruses or pathogens; and the ORAcollect·RNA and OMNIgene·ORAL sample collection devices are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in medical devices during the COVID-19 outbreak under Section564(b)(1) of the Federal Food, Drug, and Cosmetic Act,21U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. A bout 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 .