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
First Randomized Controlled Trial Shows Promise of a Ketogenic Diet in Psychotic Disorders8.7.2026 16:00:00 EEST | Press release
Published today in Schizophrenia Bulletin, a first-of-its-kind randomized controlled trial (RCT) from researchers at the University of California, San Francisco (UCSF), and funded in part by the National Institute of Mental Health (NIMH), adds to growing literature on the potential benefit of a ketogenic diet for treating psychotic disorders. The study, which enrolled participants with schizophrenia-spectrum or bipolar-1 disorders, demonstrated rapid metabolic improvements with a ketogenic diet compared to diet-as-usual during an initial one-month RCT open-label phase. Furthermore, those who continued with the optional four-month single-arm ketogenic diet extension saw meaningful gains across metabolic, psychiatric, and cognitive measures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260618626815/en/ First Randomized Controlled Trial Shows Promise of a Ketogenic Diet in Psychotic Disorders Of the 58 participants enrolled,
Teamily AI Publicly Launches Human+AI Social Platform to Make Building and Growing a Company Easy for Every Team8.7.2026 16:00:00 EEST | Press release
Teamily AI (https://Teamily.ai), together with its Agentic AI Infra platform TensorOpera AI (https://TensorOpera.ai), today announced the public launch of its Human+AI social platform, a product stack that has already served more than 5 million users around the world. Starting today in Palo Alto and rolling out simultaneously across dozens of countries, this first public launch opens the full stack to everyone with a single mission: to make building and growing a company easy for every person and every team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708584390/en/ "This is the moment we open our doors to the world," said co-founders Dr. Aiden Chaoyang He and Professor Salman Avestimehr. "We want every person and every team to be able to move from idea to product, from product to market, and from market to growth and investment, with an AI-native team by their side." At its core, Teamily AI enables humans and AI agents
Leo Cancer Care Raises $65M Series D to Scale Its Integrated Upright Cancer Care Platform8.7.2026 15:30:00 EEST | Press release
Leo Cancer Care, the medical technology company working to reinvent how patients are imaged and treated by designing systems around the body’s natural upright position, today announced the close of an oversubscribed $65 million Series D financing. The round was led by Silicon Valley’s Yu Galaxy and welcomes new investors including Eventide Asset Management, alongside continued support from the company’s existing investors. Leading cancer institutions are already adopting the upright approach. Stanford Medicine delivered the world’s first compact upright proton therapy treatment on 4 June 2026. Dana-Farber Cancer Institute and McLaren Health Care are among the institutions bringing the upright platform into their programmes — adoption that spans world-leading academic centers and smaller, regional community-based networks alike. The financing will scale manufacturing and accelerate commercial deployment, and continue clinical and product development across Leo Cancer Care’s integrated u
Fastly Joins DIMPACT to Collaborate on Digital Sustainability8.7.2026 15:00:00 EEST | Press release
Fastly, Inc. (NASDAQ: FSLY), a leading global edge cloud platform, today announced it has become a participant of DIMPACT, the coalition of leading organizations working to align industry changemakers and policymakers around meaningful, science-based solutions that reduce the environmental impacts of serving digital media products. As the first edge cloud platform provider to join the coalition, Fastly brings critical, real-world edge network data and infrastructure expertise and a transparent approach to emissions calculation and reporting to help major media, streaming, and publishing companies understand and optimize their digital carbon footprints. “We’re thrilled to welcome Fastly to the DIMPACT initiative. Their participation strengthens DIMPACT's ability to advance a more accurate, data-driven approach to measuring and reducing digital emissions,” said Jason Bell, Director at SLR Consulting and Executive Sponsor of DIMPACT. “Accurately calculating digital emissions requires a de
PubNub Introduces Blocks.ai: The Control Plane and Network Layer For AI Agents8.7.2026 15:00:00 EEST | Press release
PubNub introduces Blocks.ai today, a global network to connect and control agents across all agent frameworks, providers, and APIs. Blocks.ai lets developers reach their existing AI agents regardless of where they are hosted. Blocks Network supports all AI agent use cases without opening inbound ports, setting up tunnels, changing DNS, or modifying firewall rules. For more than a decade, PubNub has been the infrastructure and platform for real-time connectivity supporting billions of devices, now, PubNub delivers Blocks Network connecting the Internet of Agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708521206/en/ AI agents have become increasingly critical to businesses who want control over their models, code, and data. But once those agents are running locally or behind a firewall, making them reachable from custom frontends can require brittle infrastructure work. This is a key reason why McKinsey estimates th
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