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
Volue Welcomes TA Associates as New Strategic Investor13.2.2026 12:15:00 EET | Press release
Volue, a global leader in electrification and energy technology, today announced that TA Associates (“TA”), a leading global private equity firm, has joined as a new strategic investor alongside Advent International (“Advent”), Generation Investment Management (“Generation”) and Arendals Fossekompani. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213436945/en/ Over the past 18 months, Volue has undergone a strategic transformation to sharpen its focus on the energy sector. During this period, Volue divested non-core activities and invested in targeted R&D innovation and strategic acquisitions to further position Volue as a leading provider of integrated technology solutions for power trading and generation, grid optimization, and energy market intelligence. Operating at the center of one of the most mission-critical markets of our time, Volue provides technology that enables utilities, grid operators, traders, and energy
ABB strengthens electrical engineering advisory capabilities in Europe with Premium Power acquisition13.2.2026 11:30:00 EET | Press release
ABB today announced it has entered into an agreement to acquire Premium Power, a leading electrical engineering consultancy headquartered near Dublin, Ireland. For more than two decades, Premium Power has established its reputation as a trusted advisor to large customers, particularly in data centers, pharmaceutical manufacturing and other mission-critical sectors where electrical resilience, uptime and regulatory compliance are essential. The transaction is expected to close in the first quarter of 2026. Financial terms were not disclosed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213161407/en/ Paula O'Neill, Managing Director, Premium Power (L) and Owen Flood, Local Division Manager, ABB Electrification Service (R) As demand for electrification accelerates and power systems become more complex due to digitalization, renewable integration and grid constraints, customers increasingly require specialist advisory suppo
EnergyAustralia, Enerven and NHOA Energy Mark Financial Close and Project Launch of the 245 MWh Hallett Battery in South Australia13.2.2026 09:00:00 EET | Press release
NHOA Energy, global provider of utility-scale energy storage systems, today marked together with EnergyAustralia and Enerven the official project launch of a 245 MWh Battery Energy Storage System (BESS) in Hallett, near the town of Canowie, in South Australia, following the achievement of financial close and the project’s transition into the delivery phase. The milestone was announced today during a project launch ceremony held at the Hallett Power Station, attended by representatives of EnergyAustralia, Enerven, NHOA Energy, government, Traditional Owners and local community stakeholders. Owned and developed by EnergyAustralia, the Hallett BESS is being built alongside the existing Hallett gas-fired power station and represents the first stage of a broader site development. As delivery partner for Stage 1 of the project, NHOA Energy will supply a Battery Energy Storage System delivering 245 MWh of guaranteed usable energy capacity (50 MW with five hours of storage) at Beginning of Lif
Echoworx Encryption Arrives on AWS Marketplace: Frictionless Security for a Global World13.2.2026 08:00:00 EET | Press release
Echoworx, the trusted name in email encryption, is now live on AWS Marketplace—fully deployed on AWS infrastructure. For global businesses, this means securing sensitive communications just got a whole lot easier, starting from purchase. Why AWS Marketplace? Why Now? Echoworx’s mission has always been to make secure communications as easy and accessible as possible. By joining the AWS Marketplace, Echoworx is taking this mission a step further, ensuring that customers can procure its encryption solution with the same ease and efficiency they experience when using it. Cross-border compliance, taxes, and billing headaches slow teams down. With AWS Marketplace, Echoworx customers bypass the usual red tape: automated tax and regulatory handling, simple multi-currency billing, and support for Private Offers. That translates to custom pricing and contracts in local currencies, less foreign exchange guesswork, and a procurement process built for modern enterprise. "Our partnership with AWS Ma
Align Partners Issues Formal Shareholder Proposals to Gabia13.2.2026 02:37:00 EET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Gabia, Inc. (“Gabia” or the “Company”), has submitted formal shareholder proposals for inclusion in the agenda of Gabia’s upcoming 27th Annual General Meeting (“AGM”) and issued a call for strengthened governance practices to address the Company’s persistent undervaluation. Align Partners noted that, as shareholder proposals will be presented at this year’s AGM, Gabia should follow the Korea Exchange (KRX) Corporate Governance Key Indicators by publishing the AGM convocation notice at least four weeks prior to the meeting date. Align Partners emphasized that last year’s AGM notice was issued only 16 days before the meeting, limiting shareholders’ ability to adequately review the agenda and exercise informed voting rights. Gabia is widely recognized as a leading Korean IT services and cloud infrastructure company with solid operating performance. Despite these strengths, Align Partners believes the Company conti
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