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
TestMu AI (Formerly LambdaTest) Recognized in Independent Research on Autonomous Testing Platforms, Q4 20252.2.2026 19:24:00 EET | Press release
TestMu AI (formerly known as LambdaTest), the world’s first full-stack Agentic Quality Engineering platform, today announced its inclusion in The Forrester Wave™: Autonomous Testing Platforms, Q4 2025, an independent research report evaluating vendors in the autonomous testing market. The report identifies TestMu AI as a cloud-based platform for unified test orchestration and execution. It notes the platform's capabilities in cross-browser testing, real device cloud, and AI-driven automation. Specifically, the research cites TestMu AI’s testing of AI systems across dimensions, providing metrics for accuracy, intent recognition, and hallucination detection with configurable thresholds. Additionally, the report recognizes TestMu AI’s AI-powered test data generation, citing its support for Large Language Models (LLMs), multimodal inputs, and compliance-aligned workflows. The report also noted the company's strong community strategy and customers praise its responsive customer support, whi
Current Chemicals Launches as Independent Specialty Materials Manufacturer, Building on 75-Year GE Legacy with Backing from Momentum Global Ventures2.2.2026 18:04:00 EET | Press release
Today marks the debut of Current Chemicals, Inc. (CCI) as a fully independent U.S.-based specialty materials manufacturer. Backed by strategic investor Momentum Global Ventures, CCI is charting a bold new path as a trusted partner for materials innovation, custom chemistry, and U.S.-based downstream manufacturing of rare earths and critical materials. The partnership between U.S.-based CCI and Netherlands-based Momentum Global Ventures reflects a strengthening transatlantic alliance at a pivotal moment for global supply chains. This partnership underscores a shared commitment to secure, reliable, and innovation-driven materials infrastructure. Originally the chemical division of GE Lighting, the team behind CCI has served as the quiet force behind groundbreaking technologies for more than 75 years, developing processes and manufacturing advanced materials for displays, lighting, energy storage, and more. As an independent company, CCI is poised to expand its impact across industries de
Laserfiche’s Taylor Grosso Honored as 2026 CRN® Channel Chief2.2.2026 17:00:00 EET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — announced today that CRN® — a brand of The Channel Company — has selected Taylor Grosso, senior director, channel, Americas, as a 2026 CRN® Channel Chief. This annual recognition celebrates IT vendor and distribution executives who are shaping channel strategy and driving innovation and partnership across the industry. Grosso oversees Laserfiche’s Americas channel sales team, including the U.S., Canada, and Latin America, focusing on empowering Laserfiche Solution Providers to stay competitive as the market evolves. As more organizations seek out AI-powered tools to enhance productivity, Grosso prepares partners with the resources they need to quickly learn and sell Laserfiche’s industry-leading AI-powered document management solutions. By working closely with partners on building targeted business plans, Grosso and his team enable faster customer adoption of AI while driving revenue growth. “Over the past year,
Conga Completes Acquisition of PROS B2B Business2.2.2026 16:55:00 EET | Press release
Conga, a leader for AI-powered innovation in configure, price, quote (CPQ), contract lifecycle management (CLM), and document automation, today announced it has completed the acquisition of the B2B business of PROS Holdings, Inc (“PROS”) from certain investment funds affiliated with Thoma Bravo, the world’s largest software-focused investment firm. This transaction unites two industry leaders to help enterprises maximize revenue, reduce risk, and improve profitability. By bringing together AI-driven pricing optimization, configuration, quoting, and contracting capabilities, the combined company creates a differentiated enterprise platform that connects the commerce chain and enables end-to-end revenue orchestration from price to signature. The expanded Conga leadership team will continue to be led by CEO Dave Osborne. “To operate as connected, intelligent businesses, enterprises need a commerce chain that keeps everyone moving in the same direction,” said Osborne. “By bringing Conga an
Arcesium Acquires Limina to Deliver a Unified Front-to-Back Investment Platform2.2.2026 16:00:00 EET | Press release
Arcesium, a leading global financial technology provider to the investment industry, today announces its acquisition of Stockholm-based portfolio and order management (P/OMS) systems provider, Limina, creating a full front-to-back operating platform tailored to the unique needs of asset managers, hedge funds and asset owners. Through the integration of Limina’s P/OMS with Arcesium’s middle- and back-office solutions, the combined offering will be designed to eliminate legacy fragmentation and connect siloed data, providing investment managers with the speed and insight they need to operate intelligently across asset classes and global markets. The entire Limina team will join Arcesium and play a key role in ongoing product development, advancing Arcesium’s commitment to optimizing the pre- and post -investment journey for the world’s most sophisticated financial firms. Limina CEO, Kristoffer Fürst, will join Arcesium, reporting to Arcesium President, Product and Technology, Bryan Dough
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