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
Lattice to Showcase Advanced Edge AI Solutions at the FPGA-forum 202628.1.2026 23:00:00 EET | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced its exhibition plan for the upcoming FPGA-forum 2026 taking place February 11 – 12, 2026 in Trondheim, Norway. As part of the event, Lattice Corporate Vice President of Software Solutions and Applications Engineering Eleena Ong will deliver a keynote presentation exploring how rapidly maturing AI technologies can turn FPGA platforms into innovation canvases for a much broader range of developers, sparking new application possibilities. Lattice will also deliver a technical presentation and host a demo showcase focused on how its low power FPGA solutions are advancing connectivity and edge AI applications. Who: Lattice Semiconductor What / When (GMT+1): Lattice Demo Showcase (Table #3), Feb 11-12 Keynote Feb. 11, 9:30 a.m. “Unlocking the Next Wave of FPGA Innovators with Generative and Agentic AI” Technical Presentation Feb. 12, 10 a.m. “Smaller. Cooler. Smarter: Lattice FPGAs’ Path to Uncompromised
Egon Zehnder Elects German Herrera as New Chair28.1.2026 21:01:00 EET | Press release
Egon Zehnder, the world’s premier leadership advisory firm, today announced that, in accordance with its established governance and three-year election cycle, German Herrera has been elected as the Firm’s next Chair by its worldwide partnership. Herrera will assume the role effective March 1, 2026. He will succeed Michael Ensser, who has held the position since 2022, in a planned succession at the conclusion of his regular term. Herrera joined the Firm in 1998 in Bogotá and has helped shape the Firm’s global presence, taking on a broad range of leadership roles, from co-leading the Global Family Business Advisory Practice to serving on the Executive Committee and the Market Council. Most recently, Herrera has guided Egon Zehnder’s U.S. market through a period of impressive growth and transformation, which today includes 15 offices and more than 150 consultants. As the first Latinx person in this role in the industry, he actively forges strategic partnerships and joint ventures. With ex
De' Longhi Group - Record Preliminary 2025 Revenues of €3.8 Billion, up 10.4% at Constant Exchange Rates28.1.2026 20:25:00 EET | Press release
Below are the preliminary 2025 revenues for the De’ Longhi S.p.A. Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128191504/en/ 12 months, revenues at € 3,801.5 million, growing at 8.7% (+10.4% at constant currency); fourth quarter, revenues at € 1,340.0 million, growing at 5.7% (+8.2% at constant currency). Fabio de' Longhi, CEO of the Group, stated: "The Group achieved solid growth at constant currency of 10.4% in 2025, characterized by consistent results throughout the year. We are particularly pleased with the excellent performance achieved in the fourth quarter, which successfully overcame the challenges posed by the current market environment. The household division consolidated its recent growth momentum during the quarter, with organic growth of 5.2% against a challenging year-over-year comparison. This performance was primarily driven by the structural trend in coffee, amplified by strategic media investmen
Organon Completes Divestiture of JADA ® System to Laborie28.1.2026 19:45:00 EET | Press release
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today the successful closing of the sale of its JADA® System to Laborie Medical Technologies Corp. Please see our prior announcement for a summary of the transaction terms. Indications for Use The JADA® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. Contraindications Ongoing intrauterine pregnancy Untreated uterine rupture Unresolved uterine inversion Current cervical cancer Known uterine anomaly Current purulent infection of vagina, cervix, or uterus For C-sections: Cervix <3 cm dilated before use of JADA Warnings Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation. The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uter
Laserfiche Expands AI Data Capture with Auto-Classification to Transform Data into Business Intelligence28.1.2026 17:00:00 EET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — today announced major enhancements to its AI-powered data extraction tool, Smart Fields. The update introduces automated document classification and tagging, allowing organizations to move from unstructured content to informed decisions in seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128228490/en/ Using natural language prompts instead of rigid, ruled-based OCR, Smart Fields can now identify document type — such as invoices, taxpayer identification forms, or student transcripts — and automatically apply the correct metadata template using AI. Users can also use Smart Fields to automatically add informational and security tags to files that meet certain criteria, defined using a natural language prompt. Users can capture key details, route documents, and apply the proper metadata tags instantly and at scale. “Success in today’s AI-driven
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