• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Top News
    FineHeart Successfully Tests Wireless TET System

    Apria Healthcare Settles Whistleblower Lawsuit

    OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment

    Remote Patient Monitoring Market Set to Surpass $645 Million by 2025

    4C Medical Technologies Completes $10 Million Over-Subscribed Convertible Note Financing
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Spectrum Plastics Group

    K-Tube Technologies

    Unicep

    Medicoil

    Element
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Element

    Qosina Corp.

    Spectrum Plastics Group

    FUTEK Advanced Sensor Technology Inc.

    Medbio LLC
    • 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
    • Podcasts
    • Resources
    • eBook
    • 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

    FDA Clears Luminex Corp's ARIES GBS Assay

    Sample to answer GBS assay offers higher sensitivity and specificity compared to culture.

    FDA Clears Luminex Corp
    The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus nucleic acid from 18-24 hour Lim broth enriched vaginal-rectal swab specimens obtained from pregnant women.
    Related CONTENT
    • Revox Sterilization Solutions
    • Crospon Receives 510(k) FDA Clearance for Endoflip with Flip Topography Module
    • Is Your Biocompatibility Program on the Edge?
    • New 510(k) Approach Would Leverage FDA Objective Criteria
    • FDA Clears CrossBay Medical's IVF Embryo Transfer Catheter Set
    PR Newswire01.04.17
    Luminex Corporation today announced FDA clearance for the ARIES Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the FDA has cleared for use on the Luminex ARIES Systems. The company has also achieved CE-IVD marking for the ARIES GBS Assay.
     
    Infection with Group B Streptococcus (GBS), also known as Streptococcus agalactiae, is a leading cause of neonatal morbidity and mortality, causing meningitis, pneumonia and septicemia in newborns and their mothers. One in four pregnant women are colonized with GBS, with most not exhibiting symptoms; however, it can be transmitted to the newborn during delivery. If not treated, GBS can result in illness or even death in the first week of a newborn's life. The Centers for Disease Control and Prevention recommends universal GBS testing of women in their 35th-37th week of pregnancy.1
     
    The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus nucleic acid from 18-24 hour Lim broth enriched vaginal-rectal swab specimens obtained from pregnant women. It offers higher sensitivity and increased accuracy when compared to culture, and a reduced turnaround time of two hours after enrichment, compared to 48 hours for culture, with simultaneous STAT and batch testing on the sample to answer ARIES Systems.
     
    "We found the Luminex GBS assay to be user friendly, and its streamlined workflow is simpler than most other tests we have evaluated," said Thomas E. Davis, MD, PhD, Culbertson Professor of Pathology at Indiana University. "Fortunately, most GBS infections can be prevented by antenatal screening and administration of antibiotics during delivery to women determined to be GBS-positive. By providing fast and accurate results, the Luminex GBS assay could support these efforts to keep women and their babies safe."
     
    "The high level of sensitivity and accuracy of the ARIES GBS Assay over culture tests will aid in the diagnosis of more patients, ensure better quality of care, and increase patient and clinician confidence in the results," said Homi Shamir, president and CEO of Luminex. "We are delighted to have received our third FDA clearance for an assay indicated for use with our new ARIES Systems and to launch our first product for antenatal testing, increasing the value we can provide to clinicians, women, and children at a time when their need is at its greatest. We expect to accelerate the launch of additional ARIES assays as we move into 2017." 
     
    References
    1About Group B Strep. Centers for Disease Control and Prevention (Internet). Cited 2015 June. Available from: http://www.cdc.gov/groupbstrep/about.
    Related Searches
    • 2015
    • detection
    • diagnosis
    • company
    Related Knowledge Center
    • Testing
    Suggested For You
    Revox Sterilization Solutions Revox Sterilization Solutions
     Crospon Receives 510(k) FDA Clearance for Endoflip with Flip Topography Module Crospon Receives 510(k) FDA Clearance for Endoflip with Flip Topography Module
    Is Your Biocompatibility Program on the Edge? Is Your Biocompatibility Program on the Edge?
    New 510(k) Approach Would Leverage FDA Objective Criteria New 510(k) Approach Would Leverage FDA Objective Criteria
    FDA Clears CrossBay Medical FDA Clears CrossBay Medical's IVF Embryo Transfer Catheter Set
    FDA Clears NxStage Medical FDA Clears NxStage Medical's System One Hemodialysis System
    FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers
    Industry Offers Support for Gottlieb Confirmation Industry Offers Support for Gottlieb Confirmation
    FDA Approves First First Flexible Shaver for Interventional Gastroenterology FDA Approves First First Flexible Shaver for Interventional Gastroenterology
    FDA Clears Samsung FDA Clears Samsung's Digital Radiography System
    FDA Clears Edwards FDA Clears Edwards' Advanced Hemodynamic Monitoring Platform
    FDA Designates Medtronic Action as Class I Recall FDA Designates Medtronic Action as Class I Recall
    FDA Clears First Portable Unified Respiratory System for Patients on a Ventilator FDA Clears First Portable Unified Respiratory System for Patients on a Ventilator
    FDA Clears ETS Wound Care FDA Clears ETS Wound Care's Advanced Wound Matrix
    Endotronix Strengthens Management Team with Seasoned Medtech Executives Endotronix Strengthens Management Team with Seasoned Medtech Executives

    Related Breaking News

    • Diagnostics | Testing
      GenMark Diagnostics’ ePlex RP2 Receives EUA from FDA

      GenMark Diagnostics’ ePlex RP2 Receives EUA from FDA

      Provides results for more than 20 viruses and bacteria in less than two hours.
      GenMark Diagnostics Inc. 10.09.20

    • Testing
      Nelipak Facility Earns ISO/IEC 17025 Accreditation

      Nelipak Facility Earns ISO/IEC 17025 Accreditation

      Provides a comprehensive range of testing services to support package testing requirements.
      Nelipak 09.10.20

    • Diagnostics | Testing
      Alliant Offers COVID-19 Antibody Test Kits

      Alliant Offers COVID-19 Antibody Test Kits

      Allows individuals to screen for both IgG and IgM strands of the coronavirus.
      Globe Newswire 07.06.20


    • Diagnostics | Testing
      Neoteryx

      Neoteryx's Mitra Device Registered with Australian TGA

      Can now be imported into Australia for use in research and clinical diagnostic applications.
      PRNewswire 06.22.20

    • Testing
      Plastikos and Plastikos Medical Implements ISO 14698

      Plastikos and Plastikos Medical Implements ISO 14698

      This system is dedicated to test for bio-contamination, and evaluate microbiological data.
      Plastikos 04.01.20

    • Diagnostics | R&D & Design | Testing
      ClearCut Medical Appoints President & CEO

      ClearCut Medical Appoints President & CEO

      Jim Buck brings experience in developing and commercializing new technologies.
      PRNewswire 07.17.19


    • R&D & Design | Surgical | Testing
      New Technology May Lead to Implantable Artificial Kidneys

      New Technology May Lead to Implantable Artificial Kidneys

      Kidney researchers develop pioneering breakthrough in blood purification.
      PR Newswire 07.09.19

    • Machining & Laser Processing | Testing
      New Technique Reduces Latency Between Machining and Measurement

      New Technique Reduces Latency Between Machining and Measurement

      The technique calculates how long it takes for a component's temperature to be stabilized so that it can safely be measured by a coordinate measuring machine.
      University of Huddersfield 03.29.19

    • Testing
      Study: Medical Device Managers Rely on Physicians to Screen Out Defects Rather Than Issue Recalls

      Study: Medical Device Managers Rely on Physicians to Screen Out Defects Rather Than Issue Recalls

      The FDA expressed interest in using this research to improve how they oversee medical device product quality.
      Indiana University 08.22.18


    • Testing
      Sotera Health

      Sotera Health's Nelson Labs Acquires N.J.-Based Gibraltar Laboratories

      Strengthens Nelson Labs’ outsourced testing capabilities to better serve the pharmaceutical and medical device industries.
      Business Wire 08.08.18

    • Packaging & Sterilization | Testing
      Millstone Medical Welcomes Chief Information Officer to Headquarter Facility

      Millstone Medical Welcomes Chief Information Officer to Headquarter Facility

      Khrishna Mangal most recently served as a consultant for Paragon Medical.
      Millstone Medical Outsourcing 07.26.18

    • Contract Manufacturing | Machining & Laser Processing | Testing
      Empirical Celebrates 20 Years of Service in the Medical Device Industry

      Empirical Celebrates 20 Years of Service in the Medical Device Industry

      The Empirical family of companies is hosting a 20th anniversary celebration and pig roast Aug. 3-5.
      Empirical 07.24.18


    • Testing
      Nelson Labs Expands Illinois Lab Operations and Testing Capabilities

      Nelson Labs Expands Illinois Lab Operations and Testing Capabilities

      New testing capabilities will be fully operational beginning May 1.
      Nelson Laboratories 04.23.18

    • Testing
      FDA

      FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices

      Voluntary, modern 510(k) pathway may enable moderate risk devices to more efficiently demonstrate safety and effectiveness.
      U.S. Food and Drug Administration 04.13.18

    • Testing
      NAMSA Expands German Medical Device Testing Services

      NAMSA Expands German Medical Device Testing Services

      The world’s only Medical Research Organization launches new Analytical Services Laboratory in Obernburg, Germany.
      Business Wire 02.01.18


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • FineHeart Successfully Tests Wireless TET System
    • Apria Healthcare Settles Whistleblower Lawsuit
    • OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
    • Remote Patient Monitoring Market Set to Surpass $645 Million by 2025
    • 4C Medical Technologies Completes $10 Million Over-Subscribed Convertible Note Financing
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    Cistanche Tubulosa Botanical Shown to Attenuate Locomotive Syndrome
    Maternal Dietary Intake of Fish, Omega-3s, and Omega-6s Linked to Child Neurodevelopment
    Short Term Low-Carb Diet Linked to Remission of Type 2 Diabetes
    Coatings World

    Latest Breaking News From Coatings World

    Huntsman Finalizes Acquisition of Gabriel Performance Products
    PPG Completes COLORFUL COMMUNITIES Project at School in A. Bangsaothong Samutprakarn, Thailand
    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FineHeart Successfully Tests Wireless TET System
    Apria Healthcare Settles Whistleblower Lawsuit
    OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Valeo Pharma Appoints President, COO
    Metrion, LifeArc Extend Neuroscience Alliance
    Grifols Begins COVID-19 Plasma Treatment Trial
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    JLo Beauty Launches at Sephora & Amazon
    Unilever and Alibaba Group Join Forces
    Redken Unveils Acidic Bonding Concentrate Range
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    Manscaped Expands Further in Europe
    Color Street Gives Back
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Super Strong Inks Survive Tough Environments
    Ontex Honored for Mask Production
    TFP Acquires PV3 Technologies
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OrthoPediatrics Expands Agent Network in Three European Countries
    Studies Show FlareHawk Expandable Cage Delivers Favorable Fusion, Patient Outcomes
    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    Copyright © 2021 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