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
Verdantis Rebrands as the AI Super-Agent for MRO, Sets Sights on AI-Native Enterprise Asset Management8.9.2026 17:06:00 EEST | Press release
Verdantis, the AI company for spare parts and MRO inventory optimization in asset-intensive industries, today unveiled its new brand identity as the AI Super-agent for MRO and announced it is building toward a fully AI-native Enterprise Asset Management (EAM) platform. Verdantis’s super-agent orchestrates nine specialized AI agents across the decisions that decide plant uptime: spare parts, criticality, demand, reorder, and work order planning. These decisions set working capital, maintenance spend, and whether a critical asset runs and, in most plants, they are still made in spreadsheets and disconnected systems. The positioning is for the teams who own uptime - maintenance, reliability, and MRO supply chain leaders in oil and gas, mining, utilities, chemicals, and manufacturing. And it reflects an AI-first architecture: agents decide and act by default; people supervise, override, and teach the system. Every human override creates feedback that helps the system learn. That principle
HyperLight Welcomes VentureTech Alliance to Series C, Deepening TFLN Integration Across the Semiconductor Ecosystem8.9.2026 17:00:00 EEST | Press release
HyperLight Corporation ("HyperLight"), a leader in thin-film lithium niobate (TFLN) photonics, today announced that VentureTech Alliance ("VTA") has joined its Series C financing round. VTA is a venture investment firm focused on the semiconductor industry, with a portfolio built across the semiconductor technology stack — including circuit design, foundry-adjacent process technology, EDA, advanced packaging, and photonics. VTA's participation extends the ecosystem alignment that defined the round, which brought together investors spanning silicon ICs, foundry manufacturing, electronics manufacturing services, networking, and global infrastructure capital. With VTA's addition, the syndicate now reaches further into the semiconductor manufacturing and design-enablement layers on which high-volume photonics production depends. "The transition to TFLN is not a component decision — it is an ecosystem decision," said Mian Zhang, CEO of HyperLight. "Getting TFLN into volume requires the proc
EcoOnline Appoints Conor O’Loughlin as CEO8.9.2026 17:00:00 EEST | Press release
EcoOnline, a global provider of software that transforms how organisations protect people and the planet, today announced the appointment of Conor O’Loughlin as Chief Executive Officer, effective immediately. O’Loughlin succeeds Tom Goodmanson and will lead the Company into its next chapter of growth and innovation, continuing EcoOnline’s mission of keeping employees safe across the globe and supporting more than 11,000 customers. O’Loughlin is an experienced, growth-oriented technology operator and founder. He co-founded fitness technology company Glofox, scaling it into a global SaaS business serving customers in more than 80 countries before its acquisition by ABC Fitness in 2022. Following the acquisition, he served as Platform President and later Global Chief Revenue Officer at ABC Fitness, leading strategy across the company’s revenue-generating activities. “Keeping people safe at work is more important than ever, and EcoOnline does it with a depth of expertise that few can match
Hawker Operators Gain Access to High-Speed Starlink Connectivity Through Textron Aviation Customer Support Network8.9.2026 17:00:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced Starlink’s high-speed internet is now available for the Hawker 700, 800 and 900 series aircraft, following the Federal Aviation Administration’s (FAA) issuance of AeroMech’s Supplemental Type Certificate (STC). The STC includes the Starlink Aviation Performance Kit, which utilizes Starlink’s advanced constellation of Low Earth Orbit (LEO) satellites to help customers stay connected throughout their journey with more reliability over land, water and remote areas, where traditional in-flight Wi-Fi may not have service. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260908170569/en/ Hawker operators gain access to high-speed Starlink connectivity through Textron Aviation Customer Support network “Hawker operators continue to look to Textron Aviation for long-term care and upgrade solutions that ensure their aircraft remain mission-ready in today’s operat
Nanochon Performs First Case in the Chondrograft™ First-in-Human Clinical Study8.9.2026 16:47:00 EEST | Press release
Nanochon, a medical device company developing Chondrograft™, a novel 3D-printed patented implant for the treatment of articular cartilage defects of the knee, today announced the successful treatment of the first patient in its First-in-Human (FIH) clinical study. The study is designed to evaluate the safety and performance of Chondrograft™ in patients with focal chondral defects of the knee. Dr. Juan Osorio and Dr. Emilio Tufiño, who both specialize in regenerative sports medicine, performed the first procedure at The Panama Clinic, Panamá. “I am pleased to be the Principal Investigator for this important study, and we are excited to be the first to initiate clinical study enrollment. The team here in Panamá looks forward to contributing the data that will support a larger clinical study and subsequent market entry,” stated Dr. Osorio. “The speed at which Dr. Osorio and the clinical team were able to identify, enroll, and treat the first patient underscores the significant unmet clini
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