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
Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE03428.2.2026 02:00:00 EET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner IDEAYA Biosciences, Inc. (“IDEAYA”; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investigational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million milestone payment to Biocytogen. According to IDEAYA, the Phase 1 study is designed to characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and IDEAYA also intends to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances. IDE034 is a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and lice
IQM and Real Asset Acquisition Corp. to Host Conference Call/Webcast to Discuss Proposed Transaction27.2.2026 14:00:00 EET | Press release
IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), and Real Asset Acquisition Corp. (Nasdaq: RAAQ), a special purpose acquisition company (“RAAQ”), announced that they will host a conference call to discuss their recently announced business combination, including certain transaction highlights. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260227472716/en/ IQM Radiance quantum computer As previously disclosed, on February 23, 2026, IQM and RAAQ announced they have entered into a definitive business combination agreement, which will result in IQM becoming a public company and listing American Depositary Shares on one of the two leading U.S. stock exchanges. The transaction provides funding with the aim to accelerate IQM’s technology and commercial development towards fault-tolerance quantum computing, further advancing its position as a leading p
HighRadius Launches $0 Implementation Fee, $0 Subscription Fee via Outcome Based Pricing for oCFO Software27.2.2026 13:00:00 EET | Press release
HighRadius launches Office of the CFO first Outcome Based Pricing with $0 Implementation fee and $0 Subscription until Go-Live. Customers only pay a fraction of realized gains based on P&L impact. Chapter 1: Outcome Based Pricing (OBP) Introduction of OBP: HighRadius, a provider of 190+ AI agents for Order-to-Cash, Accounts Payable, Record-to-Report, and Treasury introduces Outcome Based Pricing (OBP). Three Components of OBP: Customers pay a) $0 in Implementation fees, b) $0 in Subscription fees until Go Live, c) HighRadius earns a fraction of the actual savings realized by the client. Chapter 2: US GAAP & ASC 606 Constraints Not Designed for Innovation: The traditional ASC 606 model requires companies to standardize and recognize revenue based on contractual obligations. For a traditional SaaS subscription, the obligation is access to software over time. AI agents are designed to deliver quantifiable, real-time Business Outcomes that do not fit the traditional accounting framework. C
Kioxia Appoints Yoshihiko Kawamura as Chief Financial Officer27.2.2026 10:15:00 EET | Press release
Kioxia Holdings Corporation (TOKYO:285A), a world leader in memory solutions, today announced the appointment of Yoshihiko Kawamura as Chief Financial Officer (CFO), effective April 1, 2026. Mr. Kawamura brings extensive international experience to Kioxia, having held assignments at Mitsubishi Corporation’s U.S. headquarters, served as General Manager of its Chicago office, and completed a tenure at the World Bank. At Hitachi, Ltd., he held senior leadership positions, including Chief Strategy Officer (CSO), Chief Financial Officer (CFO), and Chief Risk Management Officer (CRMO), where he was instrumental in leading the company’s management reforms. Since joining Kioxia as Executive Vice President in June 2025, Mr. Kawamura has worked closely with the executive team to advance the business through strategic capital and financial planning. Following its initial public offering on the Prime Market of the Tokyo Stock Exchange in December 2024, Kioxia is entering a new phase of growth char
DNP Invests in Rapidus to Support the Establishment of Mass Production for Next-Generation Semiconductors27.2.2026 09:18:00 EET | Press release
Dai Nippon Printing Co., Ltd. (DNP, TOKYO:7912) today announced that it has participated in Rapidus Corporation’s funding round as one of the round investors. This strategic funding initiative supports Rapidus’ plan to steadily progress from its current R&D phase to mass production of 2nm (10⁻⁹ meters) logic semiconductors by 2027. Through this initiative, DNP will advance the development and mass production of EUV lithography photomasks and support Rapidus as it establishes a mass production system for 2nm & next-generation semiconductors. Background In recent years, the rise in energy consumption, in line with increased data generation, has become a challenge, driving demand for next-generation semiconductors capable of improving device performance and reducing power consumption. Next-generation semiconductors manufactured using EUV lithography enable the formation of finer patterns on silicon wafers compared to currently available technologies. This in turn is boosting expectations
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