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
The World Goes Green for St Patrick’s Day 202617.3.2026 18:50:00 EET | Press release
This March, St Patrick’s Day invites people all over the world to become Irish for a day, as cities and communities across the globe unite in a shared celebration of heritage, culture and connection. From parades and parties to the famous global greenings, the festival’s spirit reaches far beyond Ireland’s shores. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260306890851/en/ St Patrick's Festival Kilkenny City 2022 The World Goes Green Ireland’s national holiday, St Patrick’s Day unites a global community in a vivid moment of celebration. Each year, hundreds of iconic landmarks are illuminated in green, from the Empire State Building in New York and the Leaning Tower of Pisa in Italy to Niagara Falls in Canada and the Wallace Monument in Scotland. These striking displays reflect the far-reaching connections of Irish communities overseas and the worldwide affection for Ireland’s largest national holiday. This global celebra
USD 1.63 Billion In 72 Hours: Manchester City Yas Residences by Ohana Development Sets New Sales Record In Abu Dhabi17.3.2026 17:44:00 EET | Press release
Ohana Development, a leading UAE real estate developer renowned for its luxury projects, has recorded USD 1.63 billion in sales within 72 hours for Manchester City Yas Residences by Ohana, a gated waterfront community located along Yas Canal in Abu Dhabi, setting a new sales record in the emirate’s real estate market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260317595867/en/ Manchester City Yas Residences by Ohana (Photo: AETOSWire) Investors queued at the sales launch, reflecting the strong demand for the project. Of the investors, 35% are Emiratis, while 65% are expatriates and international buyers. In response to this significant interest, Ohana Development is expected to release additional inventory from the project soon. In his comments, Husein Salem, CEO of Ohana Development, said: "We would like to express our sincere appreciation to the UAE government and its visionary leadership for fostering a stable and forw
Speech Processing Solutions Launches Philips SpeechLive Health, an AI Assistant Built for Modern Clinical Documentation17.3.2026 16:00:00 EET | Press release
Speech Processing Solutions, the global leader in professional dictation and speech solutions sold under the Philips brand, today announced the upcoming April 2026 launch of Philips SpeechLive Health AI Assistant, an AI-powered clinical documentation assistant designed for healthcare professionals across multiple care settings. This solution reduces administrative burden, streamlines documentation, and improves provider and patient experiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260317743584/en/ Philips SpeechLive Health AI Assistant turns clinical conversations into structured documentation, helping reduce administrative workload and create more time for patient care. Purpose-built for clinical documentation workflows Clinical workload remains a major challenge across healthcare. In the U.S., AMIA’s 2024 TrendBurden survey found that 77% of healthcare professionals said documentation makes them work late or at h
Coherent Solutions Releases Research on AI-driven Fraud Prevention in Banking and Finance and the Best AI Models for Banks17.3.2026 16:00:00 EET | Press release
Coherent Solutions has released a Future of Finance research illustrating how AI is advancing fraud detection in financial services. The research offers financial institutions a strategic framework to address rising and more sophisticated fraud techniques with adaptive, human-in-the-loop AI systems, based on the firm’s extensive experience in AI engineering. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260317526196/en/ Coherent Solutions releases research on AI-driven fraud prevention. This white paper addresses the modern threat of transaction fraud, which is becoming faster and smarter while conventional rule-based systems lag, leaving financial institutions exposed. Banks, credit lenders, and financial institutions that adopt AI and machine learning can reduce fraud losses by up to 50% and detect anomalies in real time. When implemented with proper governance and human oversight, AI systems also make audits smoother and
The Swoosh Meets the ‘b’: Beats and Nike Unveil Historic First-Ever Collaboration for Powerbeats Pro 217.3.2026 16:00:00 EET | Press release
Today, Beats and Nike announced the first hardware collaboration in their shared history: Powerbeats Pro 2 – Nike Special Edition. In a landmark design shift, Beats has—for the first time—shared its iconic earbud real estate with a partner, featuring the Nike Swoosh on the right bud and the signature Beats “b” on the left. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260317159868/en/ Powerbeats Pro 2 - Nike Special Edition The limited-edition release marries Nike’s high-energy “Volt” color palette with the industry-leading audio tech of the Powerbeats Pro 2. The result is a performance tool built to bridge the gap between elite sport and street style. The Nike Special Edition arrives in a striking matte black, Volt-speckled charging case. Upon opening, users are greeted by Nike’s “JUST DO IT” mantra printed inside the lid. While the aesthetic is new, the internals are pure power: Pro-Level Sound: Adaptive Active Noise Canc
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