• 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
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    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
    FDA OKs Canon Medical's One-Beat Spectral Cardiac CT

    NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite

    IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System

    Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

    Iterative Scopes Announces IBD-Focused Scientific Advisory Board
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Home Is Where the Heart (Valve) Is

    CGM: Digital Health Meets a Very Large Opportunity

    Biomechanical Engineer, Heal Thyself

    Optimizing MIM in Medical Device Manufacturing

    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    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
    PTI Engineered Plastics Inc.

    Trademark Plastics Inc.

    Spectrum Plastics Group

    Concise Engineering

    Medicoil
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

    EMS Providers Valued for Product Customization, Medical Certification Expertise

    Three Future Trends and Opportunities in Quality Assurance

    Adopting a Data-Driven Quality Model

    Digital Transformation for Quality and Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Qosina Corp.

    Unicep

    Trademark Plastics Inc.

    Medbio LLC

    Medicoil
    • 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

    Centogene Receives EUA for COVID-19 Molecular Diagnostic Test

    A real-time test for the qualitative detection of SARS-CoV-2.

    Centogene Receives EUA for COVID-19 Molecular Diagnostic Test
    Centogene’s test is intended for use by qualified laboratory personnel to be performed in the company’s CLIA certified high-complexity laboratories in Germany. Image courtesy of Centogene.
    Related CONTENT
    • Cardiovascular Device Market Expands to Tackle Higher Disease Burden
    • Global Supply Chain Wisdom from Coronavirus-Colored Lenses
    • BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing
    • Abbott's Rapid COVID-19 Self-Test Receives EUA
    • Diagnosing the IVD Market: An Interview with TEAM Technologies
    Globe Newswire07.02.20
    The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for Centogene N.V.’s SARS-CoV-2 RT-PCR test.
     
    Centogene’s SARS-CoV-2 RT-PCR test is a real-time test based on the reverse transcription polymerase chain reaction (RT-PCR) for the qualitative detection of SARS-CoV-2. It is intended to be used with samples of the upper respiratory tract collected from individuals suspected by their healthcare provider to have COVID-19, belonging to a risk cohort, or having been in contact with a confirmed COVID-19 patient.
     
    Prof. Arndt Rolfs, CEO of Centogene, said, “Over the past several months, we have been working tirelessly to ensure that we provide the best possible molecular diagnostic testing to prevent the further outbreak of COVID-19 and support the return to a new normal. This authorization by the FDA is another milestone for our COVID-19 testing efforts that validates the quality, precision and reliability of our tests.”
     
    “Centogene is proud to have received this accelerated authorization from the FDA, which recognizes our continued commitment to the highest quality standards amid this global pandemic,” said Ellen Karges, SVP regulatory compliance & quality management. “Molecular testing is vital in diagnosing patients as early as possible, and we are confident that our test will support a successful fight against this novel outbreak especially in collaboration with our pharmaceutical partners, educational organizations and airports.”
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    Cardiovascular Device Market Expands to Tackle Higher Disease Burden Cardiovascular Device Market Expands to Tackle Higher Disease Burden
    Global Supply Chain Wisdom from Coronavirus-Colored Lenses Global Supply Chain Wisdom from Coronavirus-Colored Lenses
     BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing
    Abbott Abbott's Rapid COVID-19 Self-Test Receives EUA
    Diagnosing the IVD Market: An Interview with TEAM Technologies Diagnosing the IVD Market: An Interview with TEAM Technologies
    FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device
    GE Healthcare Reveals Vscan Air Wireless, Handheld Ultrasound GE Healthcare Reveals Vscan Air Wireless, Handheld Ultrasound
    FDA Issues EUA to First OTC Home Molecular COVID-19 Test FDA Issues EUA to First OTC Home Molecular COVID-19 Test
    Quidel Quidel's QuickVue At-Home COVID-19 Test Earns EUA
    Solid Growth Forecast for Japan Solid Growth Forecast for Japan's MI Neurosurgical Devices Market
    South Korean HIV Testing to Reach Peak Market Value This Year South Korean HIV Testing to Reach Peak Market Value This Year
    Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production
    4 Trends Driving Medical Manufacturing in 2021 4 Trends Driving Medical Manufacturing in 2021
    Pioneering AI Solutions to Reinforce Healthcare Services Pioneering AI Solutions to Reinforce Healthcare Services
    BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test

    Related Breaking News

    • Diagnostics
      FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

      FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

      Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.
      Charles Sternberg, Assistant Editor 04.15.21

    • Diagnostics
      DiaSorin to Buy Luminex for $1.8B

      DiaSorin to Buy Luminex for $1.8B

      Provides access to proven Luminex multiplexing technology and molecular testing solutions.
      Sam Brusco, Associate Editor 04.13.21

    • Diagnostics
      Avantor to Acquire Ritter GmbH and Affiliates for $1B

      Avantor to Acquire Ritter GmbH and Affiliates for $1B

      Expands proprietary offering for diagnostic and drug discovery workflows.
      Sam Brusco, Associate Editor 04.12.21


    • Diagnostics
      Hologic to Buy Mobidiag for $795M

      Hologic to Buy Mobidiag for $795M

      Hologic gains near-patient, acute care diagnostic testing platforms.
      Sam Brusco, Associate Editor 04.08.21

    • Diagnostics
      EKF Launches STAT-Site WB β-Ketone and Glucose Handheld Analyzer

      EKF Launches STAT-Site WB β-Ketone and Glucose Handheld Analyzer

      Company obtains CE mark certification alongside CLIA waiver for easy-to-use whole blood analyzer for diabetes care programs.
      Michael Barbella, Managing Editor 04.07.21

    • Diagnostics
       BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

      BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

      BD Veritor Plus System supports return-to-school and return-to-work programs through serial testing.
      Sam Brusco, Associate Editor 04.01.21


    • Diagnostics
      Abbott

      Abbott's Rapid COVID-19 Self-Test Receives EUA

      Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.
      Sam Brusco, Associate Editor 04.01.21

    • Diagnostics
      BD

      BD's Combo COVID-19, Flu Rapid Antigen Test Earns EUA

      Can detect SARS-CoV-2, influenza A, influenza B from a single patient sample in 15 minutes.
      Sam Brusco, Associate Editor 03.30.21

    • Diagnostics
      FDA OKs GE Healthcare

      FDA OKs GE Healthcare's New 3D Surgical Imaging System

      OEC 3D brings precise 3D and 2D imaging to surgical suites, improving efficiency.
      Sam Brusco, Associate Editor 03.25.21


    • Diagnostics
      Optellum Receives FDA Clearance for Virtual Nodule Clinic

      Optellum Receives FDA Clearance for Virtual Nodule Clinic

      Empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the U.S.
      Charles Sternberg, Assistant Editor 03.23.21

    • Diagnostics
      FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device

      FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device

      Identifies biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions.
      Sam Brusco, Associate Editor 03.23.21

    • Diagnostics
      GE Healthcare Reveals Vscan Air Wireless, Handheld Ultrasound

      GE Healthcare Reveals Vscan Air Wireless, Handheld Ultrasound

      Touts dual-probe whole-body scanning capabilities.
      Sam Brusco, Associate Editor 03.17.21


    • Diagnostics
      FDA OKs Olympus

      FDA OKs Olympus' Narrow Band Imaging to Assess Colonic Lesions

      New evidence supports NBI to characterize polyps found during screening colonoscopies for colorectal cancer.
      Sam Brusco, Associate Editor 03.16.21

    • Diagnostics
      Roche to Acquire GenMark Diagnostics for $1.8B

      Roche to Acquire GenMark Diagnostics for $1.8B

      GenMark’s syndromic panel testing portfolio complements Roche’s current molecular diagnostics portfolio.
      Sam Brusco, Associate Editor 03.15.21

    • Diagnostics
      FDA Issues EUA to First OTC Home Molecular COVID-19 Test

      FDA Issues EUA to First OTC Home Molecular COVID-19 Test

      Results from the Cue COVID-19 test are sent directly to a companion app in about 20 minutes.
      Sam Brusco, Associate Editor 03.08.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Survey: Remote Patient Monitoring To Match Or Surpass In-Patient Within Five Years
    • Harnessing Critical Health Data With Wearable Technology
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Device Designed To Permanently Replace Failing Human Hearts
    Breaking News
    • FDA OKs Canon Medical's One-Beat Spectral Cardiac CT
    • NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite
    • IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System
    • Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development
    • Iterative Scopes Announces IBD-Focused Scientific Advisory Board
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Transporting Treatment: An Examination of Tubing Technologies
    • Face to (Virtual) Face: Telemedicine Now and Post-Pandemic
    • Outward Appearance: Reviewing Surface Treatment Options
    • 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

    Review Concludes Refined Grains Have a Place in Healthy Eating Patterns
    AstaReal Astaxanthin Ingredient Receives U.S. Patent Approval
    Study on Kemin’s DailyZz Botanical Blend Uncovers Sleep Quality, Next-Day Performance Benefits
    Coatings World

    Latest Breaking News From Coatings World

    SOS '21 Call For Papers
    ICP Acquiring Choice Adhesives
    PPG Brand Olympic Stains Announces 1st Ever 2021 Stain Color of the Year
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs Canon Medical's One-Beat Spectral Cardiac CT
    NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite
    IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Resilience Acquires Ology Bioservices
    RDIF, Hualan Ink COVID-19 Vaccine Deal
    Kintor, Visum Enter COVID-19 Manufacturing Partnership
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    2021 Perfumed Plume Awards Announces Finalists
    Bésame Cosmetics Unveils Marilyn Monroe Collection
    Procos Opens U.S. Office
    Happi

    Latest Breaking News From Happi

    Hair Luxury Company Expands Availability of Its Vegan Beauty to Walmart Online
    ACI Appoints Director, State Government Affairs
    Jergens Launches Mother’s Day Campaign
    Ink World

    Latest Breaking News From Ink World

    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    SE-DA Invests in Kornit Presto S
    Acrylic Resins Market Worth $21.9 Billion by 2025: MarketsandMarkets
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Sakata INX and INX International continue sustainability efforts
    TLMI reveals Eugene Singer Award winners at Virtual Spring Summit
    Monadnock Paper Mills joins SGP
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Andritz to Supply Elliptical Cylinder Pre-Needler in France
    Ahlstrom-Munksjö to be Delisted from Nasdaq Stockholm
    Radienz Living Introduces Sustainable Products
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    AgNovos Healthcare's AGN1 LOEP SV Kit Obtains IDE
    First Surgeries Completed with Globus Medical's CREO ONE Robotic Screw
    BioMagnetic Sciences Names President and CEO
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    SEMI, Center for Automotive Research Collaborate
    Zebra Technologies Introduces New Alliance Track for PartnerConnect Channel Program
    Virtual ASMC 2021 Spotlights Advanced Semiconductor Manufacturing Excellence

    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