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
Modon Partners With Montage Hotels & Resorts to Bring Ultra-Luxury Hospitality Brand to Egypt’s Ras El Hekma17.5.2026 14:53:00 EEST | Press release
Abu Dhabi-based Modon Holding and Montage Hotels & Resorts have announced Montage Ras El Hekma, which will introduce the first branded residences for purchase at Ras El Hekma on Egypt’s Mediterranean coast. This is the first Montage resort in Egypt – supporting the emerging city’s growth as a global hub for leisure, business and tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260517167234/en/ Modon partners with Montage Hotels & Resorts to bring ultra-luxury hospitality brand to Egypt’s Ras El Hekma (Photo: AETOSWire) Montage Ras El Hekma will feature 200 guestrooms and suites, in addition to 96 Montage Residences, and will offer a curated mix of wellness and leisure amenities, including beachfront swimmable lagoons, a Spa Montage with 13 treatment rooms, and six dining venues, alongside retail and family-oriented experiences. Designed as the experiential core of the wider community, the resort will also feature even
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Selects MEVION S250-FIT ™ for Southern Italy’s First Proton Therapy Center17.5.2026 09:00:00 EEST | Press release
Mevion Medical Systems, the global leader in compact proton therapy, today announced that it has been selected to deliver the MEVION S250-FIT Proton Therapy System™ to Istituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples. The award, made following a competitive European tender, will establish the first proton therapy center in Southern Italy, significantly expanding access to advanced radiation therapy for patients across the region and reducing the need for patients to travel long distances to northern Italy for care. Until now, proton therapy in Italy has only been available at centers located in Northern Italy, requiring patients from Southern Italy to travel significant distances for care. The Pascale project supports a broader strategy to establish Naples as a leading oncology hub and to improve healthcare equity across Italy. “The selection of the MEVION S250-FIT reflects our commitment to bringing advanced, accessible cancer care to patients in Southern Italy,” said D
TetraMem Announces 22nm Multi-Level RRAM Analog In-Memory Computing SoC Milestone16.5.2026 11:43:00 EEST | Press release
TetraMem Inc., a Silicon Valley–based semiconductor company developing analog in-memory computing (IMC) solutions, today announced the successful tape-out, manufacturing, and initial silicon validation of its MLX200 platform, a 22nm multi-level RRAM-based analog IMC system-on-chip (SoC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260516556464/en/ Photograph of the MLX200 chip with a five-cent coin for size reference The achievement marks a significant step toward the commercialization of analog computing architectures based on emerging non-volatile memory technologies, addressing the growing challenges of data movement, power consumption, and thermal constraints in modern AI systems. As AI workloads continue to scale, system performance is increasingly constrained by the cost of moving data between memory and compute units. Analog in-memory computing offers a fundamentally different approach by performing computation dir
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 19:36:00 EEST | Press release
NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s enterprise AI strategy as demand accelerates for AI-driven, cloud-native transformation. By expanding capabilities across data platforms, agentic AI and modern applications, NTT DATA is sharpening its ability to deliver production-ready AI solutions aligned to industry needs, reinforcing its leadership as Microsoft’s Global System Integrator (GSI) Growth Champion Partner of the Year. Upon closing, WinWire will add more than 1,000 skilled Azure engineers and Microsoft specialists to NTT DATA,
STARTEEPO Invest Announces 5% Stake in Xerox Holdings Corporation15.5.2026 19:15:00 EEST | Press release
STARTEEPO Invest (“STARTEEPO”), an alternative investment fund focused on public equity opportunities, today announced that it has acquired a significant ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515594020/en/ As of the date of this release, STARTEEPO and its affiliates beneficially owns 6.6 million shares of Xerox (excluding options), representing approximately 5.05% of the Company’s outstanding common stock. STARTEEPO has filed a Schedule 13D with the U.S. Securities and Exchange Commission (the “SEC”) providing additional details regarding its investment. Investment Perspective STARTEEPO believes that Xerox represents an interesting investment opportunity supported by a combination of balance sheet initiatives, ongoing operational improvements, and its position within a changing and consolidating industry. In STARTEEPO’s view, the Company
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