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
Rapid Medical™’s TIGERTRIEVER™ 13 Demonstrates Promising 90-Day Outcomes in DISTALS Trial, Reinforcing Pivotal Safety and Efficacy Findings7.5.2026 15:03:00 EEST | Press release
Rapid Medical™, a leading developer of advanced stroke treatment devices, today announced full results from the DISTALS randomized clinical trial, presented at the 11th European Stroke Organisation Conference (ESOC) in Maastricht, Netherlands, showing that TIGERTRIEVER™ 13 can safely restore blood flow to the brain and may improve clinical outcomes in patients with distal and medium vessel occlusion (DMVO) stroke. These findings build on earlier results showing a threefold improvement in restoring blood flow compared with medical management alone (p<0.0001), with no cases of serious brain bleeding observed in the treatment group. “These results show we can now safely restore blood flow and suggest this will make a meaningful difference for the right patients,” said Jeffrey L. Saver, MD, UCLA, and Principal Investigator of DISTALS. “What’s important is that both the device and the trial were designed specifically for distal stroke. By using a device built for these small vessels and mea
2 Million Downloads in Six Months: Tabelog’s Multilingual App Solves Critical Dining Pain Points for Travelers to Japan7.5.2026 15:00:00 EEST | Press release
Tabelog (https://tabelog.com/en/), one of Japan’s largest (*1) restaurant search and reservation services operated by Kakaku.com, Inc., has announced that its multilingual smartphone app (iOS/Android) for travelers visiting Japan has reached 2 million downloads (*2). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507560248/en/ 2M+ Downloads in 6 Months. The app also ranked #1 in downloads among Restaurant Search Apps in Japan for International Travelers (*3) in Taiwan, Hong Kong, South Korea, and the U.S., reflecting its immense popularity among global visitors. Download URL: https://tabelog-tourists.onelink.me/3eEh/iqkkho9r The Trusted Choice for Global Travelers: Solving Two Major Dining Pain Points in Japan For years, international visitors to Japan have faced two critical dining pain points: [Pain Point 1] The Information Gap: Most available resources are tailored for tourists, making it difficult to find the true loc
Altasciences and Certara Announce Strategic Partnership to Accelerate Early Drug Development7.5.2026 15:00:00 EEST | Press release
Altasciences, a fully integrated drug development solution company, andCertara (Nasdaq: CERT), a global leader in model-informed drug development (MIDD), today announced a strategic partnership to accelerate early-phase development programs. Fewer than half of preclinical drug candidates successfully reach first-in-human trials. Failures are driven by toxicity, poor pharmacokinetics, lack of efficacy, and challenges translating results from animals to humans. Many of these risks can be mitigated through a fully integrated model-informed drug development approach. Building on Altasciences’ Acceleration Platform, the integration of Certara’s strategic drug development services and biosimulation technology enables sponsors to establish proof of mechanism earlier, design more efficient studies, and make informed go/no-go decisions with greater confidence. By embedding modeling insights and digital workflows directly into development execution, study designs are optimized, dosing strategies
FIFA and Fanatics Expand Wide-Ranging Relationship to Include Historic Exclusive Collectibles Agreement (Trading Cards, Stickers and Trading Card Games)7.5.2026 14:00:00 EEST | Press release
In a landmark agreement expanding their already successful wide-ranging commercial relationship, FIFA and Fanatics have signed a long-term, exclusive collectibles licensing deal that features trading cards, stickers, and trading card games. The agreement, which will begin in full in 2031, covers both physical and digital collectibles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507105628/en/ An example of the product innovations that will be brought to fans under this new partnership is the highly sought-after player jersey patch program, including debut patches, which will be inserted into football trading cards from 2031 onward. All products will be designed and developed through Fanatics Collectibles and produced under the Topps brand. As a part of the deal, Fanatics will bring the magic to young people in every region of the world and support youth football globally by distributing more than $150 million in collect
DEFINITIVE Trial Reaches Major Milestone: All Centres Approved and More Than 50% Recruitment Achieved7.5.2026 12:21:00 EEST | Press release
The DEFINITIVE project, a landmark European Union-funded international phase III clinical trial evaluating the use of the HER2DX diagnostic assay to guide personalised treatment in early-stage HER2-positive breast cancer (BC), announces two major operational milestones at the ESMO Breast Cancer 2026 congress. Approvals have been obtained in the 7 participating countries, 33 clinicals sites are now open for patient recruitment. The trial has reached over 50% of its recruitment target, marking a pivotal moment on the path toward to transforming HER2-positive BC treatment. About the DEFINITIVE Project The DEFINITIVE project is a 5-year, prospective, open-label, randomised, two-arm phase III international clinical trial conducted across 44 centres in 7 European member states and associated countries. The trial aims to demonstrate that personalising treatment decisions for patients with early-stage (stage II to IIIA) HER2-positive BC using the HER2DX genomic diagnostic assay can improve pat
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