• 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
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    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—March 25

    Getinge iCast Receives FDA Premarket Approval

    Tessy Plastics Corp. Celebrates 50th Anniversary

    Carium Expands Customization Options with Care Pathways

    InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    CR-SOP Neurotechnology Helps to Achieve ‘Sound’ Sleep

    Inside the Hospital Value Analysis Committee

    Face Time: Why Getting Engineers Out of the Lab Is Good for Business

    Common Paratubing Pitfalls and How to Avoid Them

    During Times of Uncertainty, Create Business Value with an Optimized Workforce
    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
    Halkey-Roberts Corporation

    JBC Technologies

    Fusion Biotec Inc.

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing Medical Devices Revolutionized Manufacturing

    5 Current Trends in Medical Device Security

    How Advanced Sensors Improve Design & Functionality of Respiratory Care Equipment

    Sourcing Silicone Parts: Injection Mold or 3D Print?

    Cybersecurity in Healthcare: Getting on the Right Track
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    JBC Technologies

    Fusion Biotec Inc.

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The
    • 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

    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 Editor03.08.21
    The U.S. Food and Drug Administration (FDA) issued emergency use authorization for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The Cue test is a molecular nucleic acid amplification test (NAAT) that detects SARS-CoV-2 virus genetic material present in the nostrils. It’s the first molecular test authorized for at-home use without a prescription. 
     
    "The authorization of this new diagnostic test underscores FDA's goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans," acting FDA Commissioner Janet Woodcock, M.D. told the press. "The FDA will continue to expand Americans' access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States."
     
    The test is authorized for non-prescription home use to qualitatively detect SARS-CoV-2 nucleic acid in nasal swab specimens collected with the Cue Sample Wand. This test is meant for adults (self-swabbing) or children two years of age or older (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19. 
     
    The authorized test includes: the single-use Cue COVID-19 Test Cartridge, the single-use Cue Sample Wand nasal swab, the Cue Cartridge Reader (used by the Cue Health Monitoring System, provided separately), and the Cue Health Mobile Application (App) downloaded onto compatible mobile smart devices. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results to the Cue Health App in about 20 minutes. The mobile application requires an account, and in the future will be updated to include reporting test results as appropriate to public health authorities to monitor disease prevalence.
     
    Cue COVID-19 Test for Home and Over The Counter (OTC) Use correctly identified 96 percent of positive samples from individuals with symptoms and correctly identified 100 percent of positive samples from individuals without symptoms. Cue Health expects to produce more than 100,000 tests per day by summer 2021.
     
    "The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public."
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    Advanced Powder Products (APP) Advanced Powder Products (APP)
    EnMed MicroAnalytics EnMed MicroAnalytics
    Critical Software Solutions Critical Software Solutions
    IMA Automation North America IMA Automation North America
    WESTPAK Inc. WESTPAK Inc.
    Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products
    FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
    Babson Diagnostics Raises $31 Million in Series B Funding Babson Diagnostics Raises $31 Million in Series B Funding
    Picarro Unveils EtO Gas Concentration Analyzer Picarro Unveils EtO Gas Concentration Analyzer
    FDA Clears Inova Diagnostics FDA Clears Inova Diagnostics' Digital Multi-Analyte System
    VitalConnect Launches New Version of VistaCenter for Cardiac & Remote Patient Monitoring VitalConnect Launches New Version of VistaCenter for Cardiac & Remote Patient Monitoring
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    Thermo Fisher Scientific Launches Updated COVID-19 Test Thermo Fisher Scientific Launches Updated COVID-19 Test
    Vicarious Surgical Opens New Corporate Headquarters in Massachusetts Vicarious Surgical Opens New Corporate Headquarters in Massachusetts
    908 Devices Develops New Data Integrations With Key Industry Partners 908 Devices Develops New Data Integrations With Key Industry Partners

    Related Buyers Guide Companies

    • Advanced Powder Products (APP)

      Advanced Powder Products (APP)

      ...
      Nicholas Eidem, Advanced Powder Products 11.30.22

    • Testing

      EnMed MicroAnalytics

      ...
      Victoria Tan, Marketing Assistant 11.17.22

    • Critical Software Solutions

      ...
      Allen Curtis, CTO 11.16.22


    • IMA Automation North America

      ...
      Paul Beduze, Sales Manager 09.23.22

    • Packaging & Sterilization
      WESTPAK Inc.

      WESTPAK Inc.

      ...
      Tim Eells, WESTPAK, Inc. 03.04.22

    Loading, Please Wait..

    Trending
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    • A New Approach To Post-Market Surveillance
    • Tessy Plastics Corp. Celebrates 50th Anniversary
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    Breaking News
    • MPO's Most-Read Stories This Week—March 25
    • Getinge iCast Receives FDA Premarket Approval
    • Tessy Plastics Corp. Celebrates 50th Anniversary
    • Carium Expands Customization Options with Care Pathways
    • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    View Breaking News >
    CURRENT ISSUE

    March 2023

    • Sensing Technology Drives the Future of Medical Care
    • New and Developing Diabetes Technologies Offer 'Sweet Relief'
    • Discussing Matters of Substance in Medtech Materials
    • Medical Device Testers Are Caught Up in a Whirlwind
    • 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

    NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
    GOOD Meat Receives FDA Go-Ahead for Cultured Meat
    IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain
    Coatings World

    Latest Breaking News From Coatings World

    HOFFMANN MINERAL to Focus on Comprehensive Sustainability Strategy
    HMG and Prodrive Renew Technical Partnership
    Eastern Coatings Show Sets Schedule for Technical Papers
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—March 25
    Getinge iCast Receives FDA Premarket Approval
    Tessy Plastics Corp. Celebrates 50th Anniversary
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Willow, Suanfarma Complete Manufacturing Process for Cannabigerol
    Berkshire Sterile to Install nearly 1,500 solar panels at Massachusetts site
    Harm Reduction Therapeutics, Catalent Ink Naloxone Commercial Supply Pact
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Interpack 2023 Introduces New Special Areas and Activities
    eSalon Expands into Over 1,900 CVS Stores Nationwide
    The RealReal Discontinues Beauty Business
    Happi

    Latest Breaking News From Happi

    Henkel Patents Washing Agent with Improved Optical, Rheological Properties
    Food or Drink with Blended Cannabis and Vitamins
    Mermaid Brand Holdings Patents Depilatory Wax Additive
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Packaging Inks, Toyo Ink Top This Week’s Stories
    Eastern Coatings Show Announces Schedule for Technical Papers
    Pulse Roll Label Products Adds Sean Labas to Technical Sales Team
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI announces 2022 Eugene Singer Award winners
    Pulse Roll Label Products expands technical sales team
    Mark Andy introduces ProWORX Label Suite
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Heartland Polymers Begins Production, Zeta Polimeri Becomes Radici EcoMaterials & More
    Heartland Polymers Begins Production in Alberta
    Zeta Polimeri Becomes Radici EcoMaterials
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—March 25
    AI is Effective at Documenting Orthopedic Encounters in Hand Surgery
    3D LifePrints Rebrands to Insight Surgery & Launches New Business in Houston
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Dave Rahami, Zebra, Dracula Technologies Top This Week’s Stories
    Midsummer, UCLA Collaborate on Perovskite-CIGS Tandem Solar Cells
    HID Reports on Reshaping the Security Industry

    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