Business Wire

MD-MAGBIO-GENOMICS

12.9.2022 14:01:56 CEST | Business Wire | Press release

Share
MagBio Receives 510(k) Clearance and CE Mark for MagXtract Collection Tube For COVID-19 Testing

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/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

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/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Incyte Announces the European Commission Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)6.3.2026 22:42:00 CET | Press release

- Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) is the first systemic treatment for adult patients with advanced SCAC in Europe- The EC approval is based on results of the POD1UM-303 study which showed that adult patients with advanced SCAC achieved significantly improved progression-free survival with Zynyz in combination with carboplatin and paclitaxel as a first-line treatment compared to chemotherapy alone.1 Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). “The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades,” said Bill Meur

Dfns Launches Payouts6.3.2026 21:27:00 CET | Press release

Dfns today announced the launch of Payouts, a new API enabling institutions to convert stablecoins to fiat and route payouts across multiple bank accounts while keeping wallet-level governance and controls in place. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305327930/en/ Convert stablecoins to fiat and settle payouts to bank accounts in 94 countries, today. Solving the problem of single-rail off-ramps Today, most fintechs and institutions still hard-wire a single payout provider into their stack, or rely on vertically integrated models that bundle routing, pricing, custody, and settlement together. That approach may be convenient early on, but it creates structural problems at scale: weak price discovery because there is no competitive pressure on margins, limited auditability because routing decisions are opaque, and operational fragility because a single provider degradation in any corridor requires architectural i

Klarna Group Plc Clarifies Mechanics of March 9 Lock-Up Expiration6.3.2026 20:23:00 CET | Press release

Klarna Group plc (NYSE: KLAR) today issues the following clarification to ensure investors and market participants have accurate information regarding the mechanics of its lock-up expiration on March 9, 2026, the processes required before pre-IPO shares can be traded on the NYSE, and the prior liquidity opportunities already available to shareholders. This release contains only factual descriptions of the Company's share structure and applicable processes. It does not constitute guidance or a projection of any kind regarding future trading volumes, share price, or the intentions of any shareholder and speaks only as of the date of this press release. 1. 335 million locked-up shares — but two different categories Of the 378 million total ordinary shares outstanding, approximately 335 million are subject to lock-up restrictions expiring March 9, 2026. However, these shares fall into two distinct categories governed by separate sets of regulations. A. 159 million shares (48% of locked-up

Lone Star Funds Announces Agreement to Acquire the Capsules & Health Ingredients Division of Lonza Group AG6.3.2026 18:30:00 CET | Press release

Lone Star Funds (“Lone Star”) today announced that an affiliate of Lone Star Fund XII, L.P. has entered into a definitive agreement to acquire the Capsules & Health Ingredients (“CHI”) division of Lonza Group AG. As part of the transaction, Lonza will retain a 40% equity position in the business. Headquartered in Basel, Switzerland, CHI operates globally across the Americas, Europe and Asia Pacific. The business comprises three segments: Hard Empty Capsules: leading global manufacturer of gelatin and plant-based capsules offering a broad range of innovative solutions for pharmaceutical and nutraceutical customers. Dosage Form Solutions: end-to-end development and manufacturing platform serving nutraceutical and pharmaceutical customers. Health Ingredients: provider of branded, science-backed nutrition ingredients serving joint health, energy and active lifestyle markets. Lone Star believes CHI is a high-quality, globally recognized platform with strong technical capabilities, different

Sutherland Launches FinAI Hub to Industrialize Agentic AI for Banking and Financial Services6.3.2026 14:00:00 CET | Press release

A domain-trained AI agent workforce enables production-scale AI across regulated financial institution operations Today, Sutherland announced the launch of Sutherland FinAI Hub, an enterprise Agentic AI platform built exclusively for Banking and Financial Services. As financial institutions accelerate AI adoption, many initiatives remain confined to pilots, unable to scale across legacy systems and core operations. Sutherland FinAI Hub is designed to help close that gap. FinAI Hub is an innovation ecosystem where Sutherland works with clients to design, prototype, and scale Agentic AI workflows across core operations. At launch, the platform brings together a large and expanding workforce of domain-trained AI agents purpose-built for financial institutions, supporting functions across retail banking, payments, cards, consumer and commercial lending, servicing, back office, risk and compliance functions. These modular agents can operate independently or be orchestrated across end-to-end

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye