Mawi DNA Technologies Receives 510(k) Clearance for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less for SARS-CoV-2
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
CoMotion GLOBAL 2025 Unveils ‘Mayors in Motion’ Initiative: 100+ City Leaders to Accelerate Urban Innovation6.11.2025 16:00:00 EET | Press release
CoMotion GLOBAL, the world’s most influential gathering of urban mobility leaders, today announced the launch of Mayors in Motion, a landmark initiative uniting more than 100 global mayors and city leaders to accelerate urban innovation and sustainable development. The program will debut at the upcoming CoMotion GLOBAL conference in Riyadh, December 7–9, underscoring the summit’s growing role as a catalyst for collaboration among the world’s most forward-thinking cities. Designed to drive progress toward more connected, sustainable, and inclusive cities, Mayors in Motion will serve as a powerful global network for city leaders to exchange insights, coordinate strategies, and champion practical solutions. Through this coalition, participating mayors will collaborate to address critical shared challenges – from decarbonization and digital transformation to equitable access and urban resilience. The inaugural program features an exceptional lineup of current and former mayors alongside se
Game Developers Can Now Strengthen Player Loyalty and Security With Xsolla’s Expanded Fintech Ecosystem This Holiday Season6.11.2025 16:00:00 EET | Press release
Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announced the expansion of its fintech ecosystem with a new suite of Xsolla-owned payment methods just in time for the busy holiday sales season, when transactions surge. Reliable payment solutions are essential for success. These solutions are designed to help developers strengthen player loyalty, reduce transaction friction, and maintain secure, trusted checkout experiences across global markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251106730479/en/ (Graphic: Xsolla) As the gaming industry enters its peak seasonal spending period and focuses on sustaining loyal player engagement, Xsolla continues to invest in fintech innovations that connect all aspects of commerce, rewards, and security. Xsolla’s owned payment portfolio includes Xsolla Gold Gift Cards (both physical and digital) and the Xsolla Pay Loy
FIA Collaborating With Leading American University to Examine the Role of AI in Tackling Online Abuse in Sport6.11.2025 16:00:00 EET | Press release
The Fédération Internationale de l'Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, has today announced a landmark research collaboration with the University of Notre Dame, a leading research university in the United States. Supported by the FIA Foundation, the collaboration will strengthen the global response to online abuse in sport through joint research and innovation. The agreement sets out a framework for collaborative research projects between the FIA and the University of Notre Dame. These will focus on the causes, impact, and prevention of online abuse in sport, including the emerging role of artificial intelligence (AI) in both the spread of harmful content and the development of potential solutions. Additionally, they will examine how online abuse intersects with identity, alongside athlete experiences, mental health, and the regulatory response of sports federations. The University of Notre Dame and United
Tigo Energy Modernizes Installer Experience with All-Digital Installation Resources6.11.2025 16:00:00 EET | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today unveiled a comprehensive upgrade to the way the Company supports solar installers with product documentation during the installation process. Beginning in November 2025, new Tigo TS4 Flex MLPE product shipments will replace printed installation manuals with digital documentation accessible via QR codes prominently displayed directly on each product box. The change to digital documentation gives installers instant access to the most current installation guides, immersive visual guides and videos, and localization for languages in the markets Tigo serves. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251106349149/en/ Tigo’s new QR code system replaces printed manuals, giving installers like Mann Solar on-demand access to current installation guides and localized documentation. In the spirit of T
ZAPI GROUP Advances High-Voltage Capabilities for Sustainable Agricultural Machinery6.11.2025 16:00:00 EET | Press release
ZAPI GROUP, a global leader in electrification technology, will showcase its latest advancements in integrated high-voltage solutions at AGRITECHNICA 2025, taking place in Hannover from November 9 to 15. These new capabilities directly speak to the show’s guiding theme, "Touch Smart Efficiency," by providing an integrated electrification platform for innovative, networked agricultural systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251106262265/en/ ZAPI GROUP’s integrated solutions for electric agricultural machinery ZAPI GROUP’s new capabilities help agricultural Original Equipment Manufacturers (OEMs) increase efficiency, sustainability, and productivity through high-voltage power management and intelligent system integration. The exhibited solutions are engineered to meet the robust demands of next-generation electric agricultural machinery. Key products on display in Hall 15 Booth H34 will be: IMI, permanent magn
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