MagBio Receives 510(k) Clearance and CE Mark for MagXtract Collection Tube For COVID-19 Testing
12.9.2022 15:00:00 EEST | Business Wire | Press release
MagBio Genomics, Inc., a global company focused on magnetic bead-based products for molecular diagnostics and liquid biopsy genomic research, announced U.S. Food and Drug Administration (FDA) 510(k) clearance, CE Mark approval and global launch of its MagXtract Collection Tube. Used for sample collection and processing, the MagXtract Collection Tube is the first guanidine-free molecular transport medium, FDA-cleared device available in the U.S. for COVID-19 testing. In Europe the MagXtract Collection Tube is versatile, available for testing both COVID-19 and Influenza. It is also validated for bacterial and fungal sample collection and stabilization in research studies.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220912005273/en/
The new MagXtract Collection Tube from MagBio Genomics offers improved safety, stability and cost-effectiveness for sample collection and processing. Now available in the U.S. for COVID-19 testing and Europe for both COVID-19 and Influenza. MagXtract is the first FDA-cleared guanidine-free molecular transport medium that offers direct lysis and room temperature stability of RNA. The FDA has advised laboratory staff at COVID-19 sample processing facilities to avoid collection devices that use guanidine-based mediums because when cleaned with bleach, it creates cyanide gas that is highly toxic and can also be fatal. (Photo: Business Wire)
“Accurate detection of pathogens by molecular assays depends on proper collection and stabilization of samples. Poor sample stabilization results in nucleic acid degradation and overgrowth of some micro-organisms, which may lead to patient misdiagnosis,” said Hyacinth K. Ntchobo, Ph.D., CEO, MagBio Genomics. “The MagXtract Collection Tube addresses these issues by providing cost-effective room temperature sample transportation and nucleic acid stabilization over prolonged time, providing clinical laboratories with high-quality samples for accurate molecular detection of pathogens.”
With the launch of the MagXtract Collection Tube, MagBio offers improved safety, stability and cost-effective sample collection and processing to the worldwide market:
- Safety during disinfection: A guanidine-free, proprietary medium makes it safe for use in clinical settings by eliminating the risk of creating cyanide gas during cleaning, which is highly toxic and can be fatal. The FDA issued a letter to laboratory staff at COVID-19 sample processing facilities to avoid collection devices that use guanidine.
- Sample Handling and Processing Safety: The medium directly lyses cells during transport and inactivates pathogens, eliminating the need for containment use.
- Stability: Ambient temperature stability of RNA samples for up to eight days eliminates the need for cold storage/shipping.
- Efficiency and cost-effectiveness: There is no need to use a lysis buffer because the transport medium also acts as a lysis buffer, reducing costs in nucleic acid extraction workflow.
To learn more about the MagXtract Collection Tube or to request a sample pack, visit www.magbiogenomics.com.
About MagBio Genomics, Inc.
MagBio Genomics is a global company that develops and commercializes magnetic bead-based products for nucleic acid isolation, including biomarkers as tools for molecular diagnostics and liquid biopsy genomic research. The current focus encompasses products that cover complete sample preparation including safeguarding integrity of bio-samples, efficient isolation of nucleic acids and circulating biomarkers to target enrichment from biological samples. Our products are applied to human genetic research, including molecular diagnostics, cancer genomic studies and noninvasive prenatal testing. “We simply make NGS better.” For more information, visit www.magbiogenomics.com and follow the company on Twitter and LinkedIn.
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/20220912005273/en/
Contact information
Joni Ramirez
Merryman Communications
joni@merrymancommunications.com
323-532-0746
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
Enry’s Island Unveils “Enry’s Island Adventures”: Venture Capital Becomes a Videogame and Launches the “Strap” Movement on Kickstarter3.4.2026 10:47:00 EEST | Press release
Enry’s Island SpA (WBAG: EIOS), the world’s first publicly traded Venture Builder, today announced the upcoming Kickstarter launch of Enry’s Island Adventures (EIA), developed by its New York-based portfolio company, Enry’s Island Adventures LLC. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402548535/en/ The game is designed to make venture capital accessible to new generations, transforming startup creation into an engaging and social gaming experience. After three years of R&D, EIA introduces a "bleisure" model (business + leisure): players learn to launch and manage startups through gameplay that includes real business KPIs, a customizable and evolving personal island, synchronous and asynchronous multiplayer modes, social events, and community-driven seasonal missions. The “VC revolution”: teaching and democratizing through play "I agree with Elon Musk that the best way to teach is through a video game, and this is
SES Announces Results of the Annual General Meeting2.4.2026 17:49:00 EEST | Press release
SES (the “Company”) held the Annual General Meeting (“AGM”) of Shareholders today in Betzdorf, Luxembourg. Following the recommendations made by the Board of Directors of SES, the shareholders have voted in favor of all resolutions, including the Company’s 2025 annual accounts and the proposed annual dividend of EUR 0.50 per A-share (EUR 0.20 per B-share). The total dividend amount comprises the interim dividend of EUR 0.25 per A-share (EUR 0.10 per B-share), which has already been paid to shareholders on October 16, 2025. The final dividend of EUR 0.25 per A-share (EUR 0.10 per B-share) will be paid to shareholders on April 16, 2026. “I would like to sincerely thank our shareholders for their active engagement, visionary support and continued confidence in SES’ strategy,” said Adel Al-Saleh, CEO of SES. “The outcomes of today’s AGM underscore our shared commitment to a bold multi-orbit approach, with Medium Earth Orbit as the strategic backbone of a dynamically evolving global interco
Forrester: Three Years Into GenAI, Enterprises Are Still Chasing Its True Transformative Value2.4.2026 17:00:00 EEST | Press release
According to Forrester’s (Nasdaq: FORR) latest report, Accelerate Your AI Voyage, most enterprises are struggling to turn growing AI adoption and investment into measurable business impact. One of the key factors holding businesses back is low artificial intelligence quotient (AIQ) — Forrester’s measure of AI aptitude — with many employees lacking a clear understanding of how to use AI. Other barriers include an overemphasis on productivity-focused use cases, difficulty measuring impact, and siloed adoption within individual functions. While these challenges can leave firms frozen in doubt or indecision, the wait-and-see approach to AI adoption is no longer viable. To unlock AI’s full potential, organizations need to focus on four key areas: Define the business outcomes and success metrics for what they want AI to achieve; identify specific use cases for AI deployment aligned to those business outcomes; establish a structured runway to plan, test, and strategically time the deployment
Andersen Consulting Adds Multiplica2.4.2026 16:30:00 EEST | Press release
Andersen Consulting enters into a Collaboration Agreement with Multiplica, a digital consulting firm that helps organizations design, build, and scale impactful digital experiences. Founded in Spain with a presence in Latin America and the U.S., Multiplica focuses on user research and discovery, customer experience research, digital strategy, data modeling and analysis, report automation and data visualization, conversion rate optimization, product design, and user experience design. The firm helps organizations accelerate digital transformation by building digital capabilities, teams, and assets that advance expertise across digital products, consulting, and talent development. Multiplica enables clients to forecast emerging trends in digital experience and transform their businesses through enhanced digital channels and customer engagement. “Collaborating with Andersen Consulting represents an exciting opportunity to extend our reach and impact,” said David Boronat, CEO of Multiplica
Brightfin Unifies Brand Following Proven Optics Merger, Delivering a New Standard for Technology Cost Optimization2.4.2026 16:00:00 EEST | Press release
Brightfin today announced that, following its merger with Proven Optics, the combined company will operate under a single brand: Brightfin. The unified company brings together deep expertise in Technology Expense Management (TEM) and IT Financial Management (ITFM) to help organizations better understand, manage, and reduce total technology spend. Technology spending will exceed $6 Trillion this year, and for most organizations, it remains one of the least understood. CIOs can tell you what they’re spending. Far fewer can tell you whether it’s working. “Over the past several months, we’ve brought these two businesses together around a shared purpose: help enterprise businesses better understand and optimize their technology spend,” said Joel Martins, CEO of Brightfin. “What we are seeing now is a shift. Visibility alone isn’t enough. Teams need to be able to act, tied to real financial outcomes. See Clearly. Spend Better. That is our north star, and that is what our platform is built to
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