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

RevBio Launches an Experiment for its Regenerative Biomaterial on the International Space Station9.12.2022 20:04:00 CET | Press release

RevBio, Inc., announced that anexperiment to study Tetranite®, the company’s regenerative bone adhesive biomaterial, has successfully been initiated onboard the International Space Station (ISS). On Saturday, November 26, 2022, the study materials were launched to the space station on SpaceX’s 26th Commercial Resupply Services (SpaceX CRS-26) mission, sponsored by the ISS National Laboratory. This in vivo research, which will be conducted over the next two months on the ISS, will examine the biomaterial’s ability to regenerate bone when used in a microgravity environment where bone growing conditions and the ability to regenerate new bone tissue is significantly compromised. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221201005635/en/ RevBio Launches an Experiment for its Regenerative Biomaterial on the International Space Station. This Experiment will Examine TETRANITE’S Ability to Regenerate Bone under the Condition of

Datopotamab Deruxtecan Showed Promising Responses as Monotherapy and in Combination with Durvalumab in Patients with Metastatic Triple Negative Breast Cancer in Two Early Trials9.12.2022 14:00:00 CET | Press release

Updated results from the TROPION-PanTumor01 phase 1 trial showed datopotamab deruxtecan (Dato-DXd) continued to demonstrate encouraging responses in patients with heavily pretreated metastatic triple negative breast cancer (TNBC) and disease progression following standard treatment. Results were presented today as a poster presentation (Abstract #P6-10-03) at the 2022 San Antonio Breast Cancer Symposium (#SABCS22). Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN). Approximately 15% of breast cancers are considered triple negative and are associated with higher disease recurrence and worse prognosis compared to other breast cancer subtypes.1,2 It is estimated that only 12% of patients with metastatic TNBC survive five years after diagnosis and median overall survival is between 12 to 18 months.1,3 In the TNBC cohort of TROPION-PanTumor01 (n=44)

Takeda to Present Data at 64th American Society of Hematology (ASH) Annual Meeting, Demonstrating Commitment to Patients with Hematologic Cancers and Other Blood Diseases9.12.2022 14:00:00 CET | Press release

Takeda(TSE:4502/NYSE:TAK) today announced that it will present 15 company-sponsored abstracts at the 64th American Society of Hematology (ASH) Annual Meeting being held December 10-13, 2022 in New Orleans. Takeda’s latest research focuses on improving long-term outcomes for patients with hematologic diseases. Takeda’s presentations will include oral sessions detailing a three-year update of the Phase 3 OPTIC trial demonstrating the efficacy and safety of ICLUSIG® (ponatinib) in patients with resistant chronic-phase chronic myeloid leukemia (CP-CML), and results from a first-in-human Phase 1/2 study evaluating modakafusp alfa (TAK-573) in patients with relapsed / refractory multiple myeloma. “Our latest research is focused on investigating novel mechanisms of action, as well as optimizing approved treatments to improve long-term outcomes and more deeply understand and address unmet needs for patients across a range of hematologic diseases,” said Awny Farajallah, M.D., Head of Global Med

Tecnotree Advances to Acquire Top AIML Platform - CognitiveScale in North America to further Enhance 5G Use case Penetration9.12.2022 13:23:00 CET | Press release

Tecnotree is a market leader in 5G digital Business Support Systems (BSS), with AI/ML capabilities and multi-cloud extensibility. Tecnotree’s global footprint with over 90 Telecom customers in 70 countries around the world, supports ecosystems of over 1 billion subscribers. Tecnotree is the first Digital Platform Service provider to be Platinum Badge Certified by TM Forum for Real-world Open API standards. The company also provides B2B2X partner ecosystem and fintech services for monetization beyond connectivity across gaming, healthcare, education, and banking. Tecnotree has been recognized by Gartner for revenue management and monetization as well as for customer experience management solutions and enjoys the position of a leading stock on the Helsinki Nasdaq since 2020. CognitiveScale (CS) is United States based pioneer in the space of AI Engineering and provides solutions for scalable enterprise AI development and deployment. CognitiveScale is backed by over 100 granted AI patents

Another Sustainability Award for NTHU9.12.2022 10:00:00 CET | Press release

National Tsing Hua University (NTHU) in Taiwan has been awarded the Taiwan University Sustainability Award for the second year in a row! The Award was announced at the 15th Taiwan Corporate Sustainability Awards (TCSA) recently held by the Taiwan Institute for Sustainable Energy (TAISE). Standing out amongst the 47 participating universities, NTHU was ranked first in the comprehensive evaluation, and in the individual competitions received the University Sustainability Report Gold Award. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221209005001/en/ NTHU president W. John Kao (right) accepting the Taiwan University Sustainability Award from You Si-kun, president of the Legislative Yuan. (Photo: National Tsing Hua University) The judges cited the exemplary way in which NTHU has adopted an innovative approach to integrating classroom learning, campus activities and social service, thereby enriching students’ education and cre