Mawi DNA Technologies Receives 510(k) Clearance for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less for SARS-CoV-2
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
Compass Pathways Announces FDA Acceptance of IND Application for PTSD and Hosts Webinar on PTSD and TRD7.1.2026 13:30:00 EET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COMP360, enabling the initiation of a late-stage clinical trial in patients with PTSD. Compass management, along with KOL and industry leaders, will host a webinar today to discuss the company’s clinical trial plans for PTSD, as well as commercial preparations for treatment-resistant depression (TRD) from 10:00-11:30 am ET on January 7th. “PTSD is one of the most challenging mental health conditions, with approximately 13 million adults in the U.S. living with persistent symptoms and limited treatment options,” said Dr. Guy Goodwin, Chief Medical Officer at Compass Pathways. “We are pleased to advance our clinical development - the unmet need is profound, and it demands bold innovation. We believe COMP360 has the potential to tra
Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.7.1.2026 12:07:00 EET | Press release
Stallergenes Greer, a global leader in allergy therapeutics, today announced that it has entered into an agreement to acquire Entomon s.r.l., an Italian company specialising in the production of certified stinging-insect venom extracts, notably of the Hymenoptera order, used for the manufacture of diagnostic preparations and Venom Immunotherapy (VIT). The transaction is expected to close by the end of January. Entomon, currently recognised as the only company in Europe capable of extracting pure venom from Hymenoptera insects, produces pharmaceutical-grade insect venom using proprietary techniques (Entomon Capillary Extracted Venom®) for medical use. Through this acquisition, Stallergenes Greer bolsters its venom manufacturing capabilities and supply of raw materials for life-saving VIT treatments, whilst safeguarding patient care continuity. Hymenoptera venom allergy is the most common trigger of severe anaphylaxis in adults1. According to the EAACI guidelines on venom immunotherapy,
ARIS Announces New CEO to Lead Agentic AI-led Strategy7.1.2026 11:00:00 EET | Press release
CEO Appointment ARIS, a global leader in process intelligence and transformation software, today announced the appointment of Guillaume Bacuvier as Chief Executive Officer. Guillaume will lead ARIS through its next phase of growth as a fully standalone company, accelerating its evolution from a market leader in Process Intelligence into a foundational platform for enterprises deploying and governing Agentic AI. Guillaume brings deep international leadership experience across technology, data, and software-enabled businesses, with a proven track record of scaling global platforms and leading complex organisations. After starting as a strategic consultant at Booz Allen Hamilton, Guillaume spent over a decade at Google, rising to Vice President in EMEA where he built and scaled some of Google’s largest data-driven businesses in Europe and held P&L responsibility across multiple countries. In the last decade, Guillaume has served as CEO of multi-continent, data-centric companies including
I Squared Capital Acquires Ramudden Global, a Leader in Traffic Management and Infrastructure Safety7.1.2026 10:00:00 EET | Press release
I Squared Capital, a leading global infrastructure investment manager, today announced that, through its flagship fund, it has agreed to acquire Ramudden Global, from funds advised by Triton Partners (“Triton”), a leading European mid-market sector-specialist investor. Ramudden Global is a leading international provider of traffic management and infrastructure safety services supporting the maintenance and upgrade of essential transport and utility networks. The company operates more than 190 depots across 13 countries in Europe and North America delivering mission-critical services that help to ensure safety, regulatory compliance and continuity of service across road, utility and broader infrastructure works. This investment underscores I Squared Capital’s commitment to investing in essential, regulated, infrastructure businesses that underpin public safety, mobility and economic activity. Ramudden operates in markets where demand is steady and growing and benefits from deep commerci
RoslinCT and BOOST Pharma Announce Strategic Manufacturing Agreement to Advance Cell Therapy for Infants with Osteogenesis Imperfecta7.1.2026 10:00:00 EET | Press release
RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal diseases, today announced a strategic manufacturing partnership to support the development of BOOST Pharma’s cell therapy, BT-101, for the treatment of infants with Osteogenesis Imperfecta (OI), also known as brittle bone disease. Under the service agreement, BOOST Pharma has transferred its manufacturing process to RoslinCT’s state-of-the-art facilities in Edinburgh, Scotland. The partnership will progress toward GMP manufacturing of starting materials and clinical drug product, supporting Phase III clinical development of BT-101. The therapy is an allogeneic mesenchymal stem cell (MSC) product designed to address the underlying cause of OI at the earliest stages of life. BOOST Pharma was founded on pioneering science originating from Karolins
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