• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—June 3

    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA

    LifeQ Unveils New 24-Hour Sleep Solution

    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll

    EvoEndo Names CEO and Chief Operating Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    LEMO USA Inc.

    Providence Enterprise USA Inc.

    Arthur G. Russell Co. Inc., The

    Halkey-Roberts Corporation

    JBC Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    Providence Enterprise USA Inc.

    Arthur G. Russell Co. Inc., The

    Halkey-Roberts Corporation

    JBC Technologies
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test

    Adds automated extraction methods and additional PCR systems.

    PR Newswire04.27.20
    BGI Genomics. Co. Ltd. has received approval from the U.S. Food and Drug Administration (FDA) for expanding its offering of SARS-CoV-2 RT-PCR Test under emergency use authorization to include the RNA extraction kit and automated liquid handling system made by MGI, as well as additional PCR systems and sample types. BGI now provides a total lab solution for large-scale COVID-19 testing.
     
    Inclusion in the EUA of MGI's viral RNA extraction kit, which is currently in abundant supply in the US, addresses a severe sample preparation bottleneck for widespread testing. In addition, MGI's robotic sample preparation system significantly improves throughput and reproducibility. MGI's MGIEasy Nucleic Acid Extraction Kit and MGISP-960RS Automated Sample Preparation System enable processing of 192 samples in 80 minutes, a major increase in productivity compared to manual processing.
     
    "We now have a one-stop, total solution that makes it easier to ramp up large-scale, community-based testing," said Yin Ye, CEO of BGI Genomics. He added that the integrated BGI/MGI solution has been effectively used first in China and later on in many countries scaling up testing laboratories to perform up to 50,000 tests a day.
     
    The expanded FDA EUA label also increases the accessibility of test kits to include more types of PCR instruments—besides Thermo Fisher's ABI 7500 Real-Time PCR System, now ABI 7500 Fast, QuantStudio 5 and Roche LightCycler 480, are also approved for use with BGI's test.
     
    The FDA also expanded the label of the kit to cover more respiratory sample types. Now throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) sample are all compatible with BGI's RT-PCR kit. More flexibility in sample types will increase the clinical utility of the kit to overcome the other testing bottleneck caused by a shortage of sample collection kits.
     
    The amendment announced today expands options for viral RNA extraction from Qiagen's QIAamp Viral RNA Mini Kit to cover MGI's MGIEasy Nucleic Acid Extraction Kit. The kit offers comparable performance along with high throughput and addresses the current supply shortage of extraction kits in the US market.
     
    The Centers for Medicare & Medicaid Services (CMS) on April 15, 2020 announced that Medicare will nearly double payment for lab tests that use high-throughput technologies to rapidly diagnose large numbers of COVID-19 cases. At a time when the United States still urgently needs to enhance its capacity for community COVID-19 testing, the integrated workflow delivered by BGI will allow clinical laboratories to effectively adopt high-throughput testing solutions.
     
    The integrated solution of MGI sample preparation with the BGI RT-PCR kit is part of a comprehensive solution BGI Group has introduced for rapidly scaling up diagnostic testing—the Huo-Yan or Fire Eye labs. The Fire Eye Laboratory model that demonstrated its early success in Wuhan, China where the virus was first identified, is now being implemented in Europe, Middle East, Asia and around the world. Fire Eye laboratories combine the best of BGI Group expertise, with the most recent labs launched in the UAE and Sweden.
     
    BGI Genomics and its US subsidiary, BGI Americas Corp., announced on March 27, 2020 that the FDA had issued EUA approval for its RT-PCR kit for detecting SARS-CoV-2. It was the first FDA approved RT-PCR product for COVID-19 testing manufactured in China. BGI Genomics currently has a manufacturing capacity of 2 million tests per day and is fulfilling international orders from more than 80 countries and regions around the world.
     
    BGI's RT-PCR Test for SARS-CoV-2 is one of the most reliable and widely used testing methods available, with over 2 million tests already performed. In addition to the US FDA, BGI's RT-PCR Test for SARS-CoV-2 has been granted emergency approval by Europe's EMA, China's NMPA, Japan's PMDA and Australia's TGA.
    Related Searches
    • roche
    • diagnostic
    • it
    • ceo
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    Carclo Technical Plastics Carclo Technical Plastics
    Simbex Simbex
    SigmaTron International SigmaTron International
    FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
    Thermo Fisher Scientific Launches Updated COVID-19 Test Thermo Fisher Scientific Launches Updated COVID-19 Test
    Roche to Acquire Long-Term Partner TIB Molbiol Roche to Acquire Long-Term Partner TIB Molbiol
    Roche Roche's COVID-19 Molecular Test Granted EUA
    Safeguard DNA Diagnostics Launches Dry Collection Swabs for COVID-19 Testing Safeguard DNA Diagnostics Launches Dry Collection Swabs for COVID-19 Testing
    FDA Extends EUA for Spectrum Solutions’ SDNA-1000 Saliva Collection Device FDA Extends EUA for Spectrum Solutions’ SDNA-1000 Saliva Collection Device
    Abbott Abbott's Panbio Rapid COVID-19 Antigen Self-Test Earns EU Approval
    COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028 COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028
    QIAGEN Launches Technology to Triple COVID-19 Lab Testing Capacity QIAGEN Launches Technology to Triple COVID-19 Lab Testing Capacity
    Quidel Granted EUA to Market COVID-19 Antigen Test Quidel Granted EUA to Market COVID-19 Antigen Test
    QIAGEN Granted EUA for its 4-Plex COVID-19 Test QIAGEN Granted EUA for its 4-Plex COVID-19 Test
    CerTest Biotec & BD Add Saliva to the Visasure SARS-CoV-2 Detection Kit CerTest Biotec & BD Add Saliva to the Visasure SARS-CoV-2 Detection Kit

    Related Buyers Guide Companies

    • Carclo Technical Plastics

      Carclo Technical Plastics

      ...
      Steve Janik, Sales and Marketing Coordinator 11.11.22

    • Simbex

      ...
      Greg Lange, Chief Business Development Officer 10.05.22

    • SigmaTron International

      SigmaTron International

      SigmaTron International is a full service EMS provider with a network of manufacturing facilities in the United States, Mexic
      Susan Mucha, President PMCI 11.12.21


    • Diagnostics
      FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

      FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

      May be related to current mixing parameters of the PCR reaction mixture.
      U.S. Food and Drug Administration 09.20.21

    • Thermo Fisher Scientific Launches Updated COVID-19 Test

      Thermo Fisher Scientific Launches Updated COVID-19 Test

      Updated version of highly sensitive and accurate COVID-19 PCR kit accounts for known and future viral mutations.
      PR Newswire 09.10.21

    Loading, Please Wait..

    Trending
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • FDA Clears Sanara MedTech's Advanced Surgical Solution
    • Titan Medical Licenses Most IP To Intuitive; CEO Steps Down
    Breaking News
    • MPO's Most-Read Stories This Week—June 3
    • CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    • LifeQ Unveils New 24-Hour Sleep Solution
    • Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    • EvoEndo Names CEO and Chief Operating Officer
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures and Carbios Reaffirm Partnership to Build PET Biorecycling Plant
    AkzoNobel Powder Coatings Enhances Digital Services with Launch of My Interpon Portal
    PPG Opens Color Creation Lab with Chery Automobile in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—June 3
    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    LifeQ Unveils New 24-Hour Sleep Solution
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Terran Biosciences, Pierre Fabre Ink Exclusive Licensing Deal for Idazoxan
    ASM Research Chemicals Launches Development Packs for API Manufacturing
    WuXi Increases Manufacturing Capacity in Germany
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    An Eco-Friendly & Stylish PET Dropper for Cosmetic Products New from Epopack
    Color Street Celebrates Pride Month with Limited-Edition ‘Over the Rainbow’ Nail Strips
    Olay Rolls Out Sensitive Skin Line
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX Digital, hubergroup and HP Top This Week’s Stories
    Mactac Acquires Canadian Roll Label Distributor Label Supply
    WestRock Advances its Commitment to a Sustainable Future
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner's Pharma-Comb IL Label supports clinical trial cancer medication
    First Anytron ANY-JET III digital label press installed in Korea
    FPA announces Kasie Fairbarn as elected ELC co-chair
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 3
    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Francisco Melo, Smart Skis, onsemi Top This Week’s Stories
    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login