Mawi DNA Technologies Receives 510(k) Clearance for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less for SARS-CoV-2
25.4.2023 15:00:00 EEST | Business Wire | Press release
Mawi DNA Technologies (Mawi DNA), a biotechnology company focusing on the development and design of innovative technologies for biosampling, announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s iSWAB-Respiratory Tract Sample Collection Media-Extraction Less™ (iSWAB-RC-EL). The iSWAB-RC-EL collection device is intended for the stabilization and inactivation of human upper respiratory and saliva bio specimens suspected of containing SARS-CoV-2, and can be used for collection, transport, and storage at ambient temperature. Specimens collected in the iSWAB-RC-EL collection device are suitable for use with legally marketed molecular diagnostic tests.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230425005502/en/
(Graphic: Business Wire)
Mawi DNA developed the iSWAB-RC-EL bio sampling device for surveillance testing of COVID-19 and its variants in any clinical setting. The iSWAB-RC-EL is currently being used worldwide for population-scale sampling to mitigate the impact of COVID-19 spread, and it enables hospital and clinical lab personnel to skip the RNA extraction step in the PCR testing protocol. The biosampling device also offers a non-toxic formulation that inactivates viruses to decrease potential spread and exposure, especially among lab personnel processing these samples.
“Our goal was to respond to current and future pandemics faster by removing the need for RNA extraction and the consumables required to process viral samples, which also has the added effect of increasing testing throughput,” said Dr. Bassam El-Fahmawi, Ph.D., chief executive officer and chief technical officer of Mawi DNA Technologies. “This product was also formulated to be non-toxic and non-hazardous by being free of guanidine salts while inactivating the virus, so our colleagues processing samples can conduct this invaluable service with peace of mind.”
Mawi DNA developed the new iSWAB-RC-EL collection device to address many of the inefficiencies in viral sample collection and transport technologies exposed during the COVID-19 pandemic, especially with cold chain transportation requirements and extremely short time frames for viral nucleic acid stabilization. The pandemic also exposed supply chain weaknesses, including shortages of RNA extraction reagents.
The iSWAB-RC-EL collection device is available immediately to hospital and clinical labs. To learn more about the iSWAB-RC-EL collection device or to request a sample, visit https://mawidna.com/request-sample-kit/.
About Mawi DNA Technologies
Mawi DNA Technologies, founded in 2013, has developed and commercialized the iSWAB technology, an innovative system for collection of biosamples. Mawi DNA’s mission is to uphold sample integrity from anywhere in the world at room temperature, enabling true sample diversity across any geography or population segment. At Mawi DNA, The Future of Biosampling is Here™. For more information, visit www.mawidna.com and follow the company on LinkedIn and Twitter.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230425005502/en/
Contact information
Investors
Jerome David, Chief of Staff
Mawi DNA Technologies
510-256-5186
j.david@mawidna.com
Media
Jessica Volchok
jessica@merrymancommunications.com
310-849-7985
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Kinaxis Introduces Maestro Agent Studio, Unlocking Next Level Decision Making Through Composable AI Agents5.2.2026 14:01:00 EET | Press release
Kinaxis® Inc. (TSX: KXS), the leader in supply chain orchestration, today announced Maestro Agent Studio, making the next phase of its AI agent strategy available to customers following the launch of prebuilt Maestro Agents. Maestro Agent Studio gives supply chain teams a no-code way to compose AI agents grounded in their real operating context, using the same data, workflows, and tools planners already rely on, so agents drive real-world outcomes. Built into the Kinaxis Maestro® platform, Maestro Agent Studio enables supply chain teams and leaders to apply their expertise across every day and high-impact supply chain decisions without relying on manual, repetitive tasks or custom code development. Maestro Agent Studio is designed to work with leading large language models, including OpenAI’s GPT and Google Gemini, while keeping agent behavior anchored in Maestro’s trusted data, intelligence, and governance. The reality facing supply chain leaders Supply chain teams make decisions in e
Introducing RAVE Aerospace: A New Name, Built on a Legacy of In-Flight Innovation5.2.2026 14:00:00 EET | Press release
For nearly two decades, RAVE has been a trusted name in in-flight entertainment and connectivity for customers around the world. Today, that heritage continues under a new company name: RAVE Aerospace. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205748681/en/ Kingswood Capital Management, LP (together with its affiliates, “Kingswood”) has completed its acquisition of Safran Passenger Innovations (“SPI”), a leading global provider of in-flight entertainment and connectivity solutions, from Safran, an international aerospace group. As part of the transaction, SPI has been renamed as RAVE Aerospace, which will continue to build on the established RAVE brand that has powered in-flight entertainment and connectivity solutions for its customers for almost 20 years. Matt Smith will continue to serve as Chief Executive Officer, supported by the existing leadership team, as RAVE Aerospace accelerates its growth as a leading glo
Menicon’s Largest Malaysia Plant Begins Commercial Production5.2.2026 11:00:00 EET | Press release
Menicon Co., Ltd. is pleased to announce that its new manufacturing facility in Kedah, Malaysia, has commenced commercial production. The plant strengthens Menicon’s long-standing commitment to technological excellence, uncompromising quality, and a stable global supply of contact lenses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127294120/en/ The newly opened Malaysia plant is Menicon’s largest site to date and is dedicated exclusively to producing 1-DAY lenses. As global demand for 1-DAY lenses continues rising and the industry faces widespread supply constraints, Menicon has made significant capital investments to expand production capacity—even amid the uncertainties presented by the COVID-19 pandemic. Construction of phase 1, currently underway, will provide capacity for up to 500 million lenses per year. The construction plan is strategically formulated to extend through phase 4, allowing for further expansion
Ryan Expands UK Business Rates and Property Tax Capabilities with Acquisition of WYM Rating5.2.2026 10:00:00 EET | Press release
Ryan, a leading global tax services and software provider, is pleased to announce the acquisition of Williams Young McKaig Ltd, a specialized commercial property consultancy, and its specialist rating division, WYM Rating, based in Edinburgh. The acquisition establishes Ryan’s property tax and business rates presence in Scotland and expands the Firm’s ability to serve clients with complex commercial property portfolios across the United Kingdom. Founded in 2012 by Richard Williams, Don Young, and Billy McKaig, WYM Rating is recognized for its client-centered approach and deep expertise across commercial property advisory. The consultancy supports landlords, occupiers, and investors through practical, market-informed advice grounded in decades of hands-on experience. WYM Rating’s capabilities span three focus areas, closely aligning with Ryan’s capabilities: Business rates and property tax Commercial property advisory Occupier and lease advisory “WYM Rating brings exactly the kind of sp
Fujirebio and Sysmex Begin Sales Collaboration for Dementia Testing5.2.2026 08:30:00 EET | Press release
Fujirebio Holdings, Inc. (HQ: Minato-ku, Tokyo; President & CEO: Goki Ishikawa; “Fujirebio”), a consolidated subsidiary of H.U. Group Holdings, Inc. (HQ: Minato-ku, Tokyo; Chairman, President and Group CEO: Shigekazu Takeuchi) and Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano, “Sysmex”) have agreed on a sales collaboration for dementia testing. This agreement follows continued discussions based on the Basic Agreement on Business Collaboration in the Field of Immunoassay concluded in October 2023.1 Sysmex will exclusively sell Fujirebio's fully automated Lumipulse® immunoassay systems and dementia-related reagents ("the Products") in regions and countries mutually agreed upon by both companies. Going forward, Fujirebio and Sysmex will collaborate to meet the growing testing needs accompanying the wider adoption of therapeutic drugs and will gradually expand the countries where the Products are sold. Since entering into the Basic Agreement on Business Collaboration in Octob
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom