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
Octane AI Launches Phoenix, an AI Quiz Builder That Builds, Checks and Improves Quizzes for Shopify Brands21.10.2026 20:15:00 EEST | Press release
Octane AI, the quiz and zero-party data platform for Shopify brands, launched Phoenix in October, its biggest release to date. Merchants describe the quiz they want or upload what they already have, and Phoenix builds it, checks it, personalizes the results and keeps improving it with experiments. One beta customer turned a single document into a complete product-launch quiz: “I attached it to Phoenix, and it built the whole thing, all the pages. It understood everything, not just the text but the logic behind it.” Across all live Octane AI quizzes, 15% of shoppers who finish a quiz place an order. Yet building one has meant hours of writing rules by hand, custom code for design and clicking through every path to find broken results. Phoenix handles those hard parts, from building a quiz to improving it after launch. “Since day one, we've kept track of every piece of feedback from our merchants: what frustrates them and what they wish Octane AI could do. Phoenix is the result, and it k
Cognite Earns Corporate Supplier of the Year Award from Marathon Petroleum Corporation21.10.2026 20:06:00 EEST | Press release
Cognite today announced it has been named Corporate Supplier of the Year winner in Marathon Petroleum Corporation’s 11th Annual Supplier Recognition Awards. The Supplier Recognition Awards is a program sponsored by Marathon Petroleum Corporation to honor suppliers that positively impacted the company’s business throughout the previous calendar year. “There’s a reason ‘Impact’ is one of Cognite’s most important core values,” said Girish Rishi, CEO of Cognite. “For us, the ultimate measure of our performance is delivering quantifiable value for our customers. From that perspective, the Corporate Supplier of the Year award from Marathon is particularly meaningful. Marathon Petroleum is an innovator, and to receive this recognition is a great honor to the Cognite community.” The Supplier of the Year Award from Marathon is the latest honor Cognite has received in 2026: In May, Cognite ranked 15th on CNBC’s Disruptor50 list, honoring venture-backed companies innovating across industries, exp
The Estée Lauder Companies Inc. to Webcast Capital Markets Experience: China Ecosystem Immersion Presentations on November 4, 202621.10.2026 19:48:00 EEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced that it will webcast presentations from its Capital Markets Experience: China Ecosystem Immersion in Shanghai, China, on Wednesday, November 4, 2026. The event will feature presentations from Stéphane de La Faverie, President and Chief Executive Officer, and Akhil Shrivastava, Executive Vice President and Chief Financial Officer, as well as members of the Company’s Executive Leadership Team and local leaders. The presentations will highlight the Company’s strategy and capabilities in China, Beauty Reimagined in action, and how China serves as a blueprint for deploying the Company’s global capabilities to drive sustainable growth and stronger profitability. Due to limited capacity, in-person attendance is by invitation only. Interested parties can access the live webcast on Wednesday, November 4th, beginning at 1:00 p.m. China Standard Time (12:00 a.m. ET) at Investors – The Estée Lauder Companies Inc. A replay of the webcast wi
Future Health and Bridge for Billions to Launch Programme Strengthening Health Entrepreneurship in Emerging Markets21.10.2026 18:50:00 EEST | Press release
Future Health – A Global Initiative by Abu Dhabi and Bridge for Billions will launch a new entrepreneurship programme designed to strengthen promising health ventures in emerging markets and help locally-developed solutions reach more people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021719421/en/ The first phase of the programme will target around 50 entrepreneurs leading late-incubation to early-acceleration ventures in Africa and Asia. Emerging markets are home to significant health needs and entrepreneurial potential, yet many promising ventures can struggle to access the capital, specialist guidance, and health-system connections required to grow. WIPO’s Global Innovation Index 2024 reported that Latin America and Africa together accounted for around 3% of global venture-capital deals in the first half of 2024, while venture-capital values fell by 19% in Asia-Pacific and 80% in Africa. At the same time, entrepre
Hephaestus Exits Stealth Having Raised $17.2M to Supply Rare-Earth-Free HTS Superconductors and Build Low-Cost Fusion Power21.10.2026 17:48:00 EEST | Press release
Hephaestus today emerged from stealth with solutions that address two of the largest cost drivers in fusion power: the high temperature superconducting (HTS) magnets that confine the plasma, and the edge-localized modes (ELMs – major plasma instabilities) that drive up the cost and complexity of conventional reactor designs. The company also announced the close of a new funding round led by CiRi Ventures. Hephaestus was founded in London in 2019 with a single mission – to help make fusion energy cheap enough to compete on the grid. Its AI plasma solver initially swept the full space of tokamak design parameters, unconstrained by the legacy designs and materials much of the industry is already committed to, and identified negative triangularity (NT), which inverts the D-shaped plasma used in most tokamaks, as the most likely configuration for low-cost fusion energy. Subsequent results from facilities worldwide, including the DIII-D, JET, and SMART, have shown that NT can deliver strong
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