Business Wire

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

Share

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.

Contact information

Joni Ramirez
Merryman Communications
joni@merrymancommunications.com
323-532-0746

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

AUTEL Launches Energy Storage Solutions7.10.2022 20:19:00 CEST | Press release

AUTEL (AUTEL EUROPE GmbH) launched its new energy storage solutions at eMove360° Europe 2022, for energy storage systems, commercial and industrial applications, and residential uses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221007005488/en/ The smartest hub to direct your home energy: Autel Hybrid Inverter (Photo: Business Wire) "With over 10 years of R&D experience, Autel continues to deliver industry breakthroughs in core technologies such as power electronics," said Mr. Ting Cai, CEO of Autel Europe GmbH. Autel offers optimal Levelized Cost of Electricity (LCOE) with improved safety achieved through continuous innovation in string design to address key industry challenges. The energy storage range includes the Autel Hybrid Inverter and the Autel ESS All-in-one. Autel Energy Storage Solutions address capacity limitations AUTEL believes that its energy storage products are capable of solving the problems of limited c

Acathia Capital Completes Acquisition of Swedish Life Insurer Futur Pension7.10.2022 11:51:00 CEST | Press release

With the receipt of approvals from the Swedish Financial Supervisory Authority, Acathia Capital has completed the increase of its stake in Futur Pension Försäkrings AB, the most successful life insurer in Sweden. Since 2019, Acathia Capital has been the joint lead investor, together with the Nordic private equity manager Polaris, in this investment, within a group of 5 institutional investors. As a result of the transaction, investment vehicles advised by Acathia have increased their joint stake in Futur Pension from 30% to almost 50%. Futur Pension is a powerful demonstration of how digitalization is fundamentally transforming the insurance business. The fintech, founded in 2000, has already fundamentally transformed the Swedish life insurance market in terms of cost and market share structure. Dr. Thomas Schmitt, managing partner of Acathia Capital, comments: “Futur Pension has increased its market share from 7% to over 11% of premium volume since we have become owners in 2019, makin

EIG’s MidOcean Energy to Acquire Tokyo Gas’ Interests in Portfolio of Four Australian Integrated LNG Projects for US$2.15 Billion7.10.2022 10:44:00 CEST | Press release

MidOcean Energy (“MidOcean”), an LNG company formed and managed by EIG, a leading institutional investor in the global energy and infrastructure sectors, today announced that it has entered into a definitive agreement with Tokyo Gas Co., Ltd (“Tokyo Gas”) to acquire Tokyo Gas’ interests in a portfolio of four Australian integrated LNG projects. Under the terms of the agreement, MidOcean will acquire Tokyo Gas’ interests in Gorgon LNG, Ichthys LNG, Pluto LNG and Queensland Curtis LNG for total cash consideration of US$2.15 billion. These integrated projects span Australia’s western and eastern seaboard and are major suppliers of LNG to Asia, with a diverse set of long-dated take or pay contracts with investment grade counterparties, and to Australia’s domestic gas markets. The portfolio is expected to generate approximately 1 million tonnes per annum of LNG net to MidOcean, production that is underpinned by long-life reserves and a globally competitive cost structure. The portfolio bene

LabGenius Secures Government Innovation Grant to Expand ML-driven Drug Discovery Platform, EVA™7.10.2022 09:00:00 CEST | Press release

LabGenius, a pioneer in the use of machine learning (ML) for antibody engineering, today announced that it has been awarded a highly competitive SMART grant from Innovate UK. Grants from the £25 million fund allow businesses like LabGenius to realize the potential of new ideas by investing in game-changing, commercially viable research and development projects. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221007005023/en/ To date, LabGenius’ EVA platform has been used to co-optimize mono- and multi-specific single domain antibodies for biochemical and bio functional properties, including stability, potency and selective tumor cell killing. This grant will be used to further expand EVA's capabilitiesby accelerating the platform’s ability to optimize antibody-based immune cell engager molecules. Many existing antibody therapeutics have poor selective cell killing profiles, which can result in on-target, off-tumor effects, an

Slate Asset Management Provides Fleet Financing to Move About Group AB to Support Rollout of Electric Vehicles and Charging Infrastructure Across Europe7.10.2022 09:00:00 CEST | Press release

Slate Asset Management (“Slate”), a global alternative investment platform targeting real assets, today announced that it has agreed to provide financing to Move About Group AB (“Move About”), a Swedish electric mobility service, to support the roll out of more than 150 electric vehicles and electric vehicle charging infrastructure throughout Europe. The car funding provided by Slate will be used to bolster Move About’s electric car fleet, which currently owns and operates over 800 electric cars and has more than 71,000 users on its platform. Move About is a Sweden-based electric mobility service that delivers environmentally friendly and cost-effective mobility solutions to over 300 locations across Sweden, Norway, and Germany. Move About has partnered with some of the largest companies across Europe to save tons of carbon dioxide emissions every year. Since it was founded in 2007, Move About has become the largest provider of emission-free carsharing in the Nordic region. Christian S