• 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
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    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
    Endologix's AFX2 Endovascular AAA System Earns EU Nod

    Elizabeth Coleon Joins Withings as Chief Marketing Officer

    U.K. Strengthens Medical Device Regulations

    Fujirebio Acquires ADx NeuroSciences

    IVD Market to Decline Steadily by 2030
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    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
    Xact Wire EDM Corp.

    BMP Medical

    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things

    Leveraging Open Healthcare Data Standards to Improve Medical Device Manufacturing

    3 Ways Privacy-Enhancing Technology Will Improve Medical Products Innovation
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Xact Wire EDM Corp.

    BMP Medical

    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    Fusion Biotec Inc.
    • 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.

    Related CONTENT
    • WESTPAK, Inc.
    • IMA Automation North America
    • Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products
    • FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
    • Babson Diagnostics Raises $31 Million in Series B Funding
    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
    WESTPAK, Inc. WESTPAK, Inc.
    IMA Automation North America IMA Automation North America
    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
    Roche Roche's COVID-19 Molecular Test Granted EUA
    Westfall Technik Opens New Medical Molding Plant and Clean Room Westfall Technik Opens New Medical Molding Plant and Clean Room
    FDA Issues EUA for BD Veritor At-Home Covid-19 Test FDA Issues EUA for BD Veritor At-Home Covid-19 Test

    Related Buyers Guide Companies

    • WESTPAK, Inc.

      WESTPAK, Inc.

      ...
      Tim Eells, WESTPAK, Inc. 03.04.22

    • IMA Automation North America

      ...
      Paul Beduze, Sales Manager 09.23.21

    • Surgical
      Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products

      Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products

      Deliver consistent sealing reliability in an ergonomic, multifunctional design that promotes procedural efficiency.
      Olympus Corporation 09.21.21


    • 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

    • Diagnostics
      Babson Diagnostics Raises $31 Million in Series B Funding

      Babson Diagnostics Raises $31 Million in Series B Funding

      Money will be used to help drive commercialization of customer-first, highly accessible diagnostic blood testing.
      Business Wire 09.20.21

    Loading, Please Wait..

    Trending
    • MPO's Most-Read Stories This Week—Aug. 6
    • The Future Of Biomedical Engineering Advancements
    • How Are Hypodermic Needles Made?
    • Mark Miles Appointed Chief Commercial Officer At Ancora Heart
    • Microneedle Patch Glucose Monitor Proves Virtually Painless And More Accurate
    Breaking News
    • Endologix's AFX2 Endovascular AAA System Earns EU Nod
    • Elizabeth Coleon Joins Withings as Chief Marketing Officer
    • U.K. Strengthens Medical Device Regulations
    • Fujirebio Acquires ADx NeuroSciences
    • IVD Market to Decline Steadily by 2030
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • 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

    Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds
    3i Solutions Announces New Leadership Positions
    INS Nutra Opens Gummy Manufacturing Facility
    Coatings World

    Latest Breaking News From Coatings World

    Lanxess' Entire Value Chain to Become Climate-Neutral
    Custom Cars Featuring PPG DELTRON Refinish System Take Awards at Goodguys 24th Summit
    HGTV Home by Sherwin-Williams Announces 2023 Color Collection of the Year
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Endologix's AFX2 Endovascular AAA System Earns EU Nod
    Elizabeth Coleon Joins Withings as Chief Marketing Officer
    U.K. Strengthens Medical Device Regulations
    Contract Pharma

    Latest Breaking News From Contract Pharma

    BioIVT Acquires Scottish Drug-metabolizing Enzyme Manufacturer Cypex
    Schott Creates Stand-Alone Company for its Pharma Business
    Marken to Acquire Medical Courier Business of Cedra Express
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Body Shop Expands Partnership with Uber
    COSRX Launches Vitamin E Vitalizing Sunscreen
    Weekly Recap: Kylie Makeup Lab Controversy, Glossier Pivots to Retail and Wholesale & More
    Happi

    Latest Breaking News From Happi

    Hallstar To Purchase Lanxess’ Polymer Additives Production Site in Greensboro, NC
    Uber and The Body Shop Expand On-Demand Delivery Partnership Nationwide
    Australia-Based Teeth Whitening Technology Leader White Glo Enters US Market
    Ink World

    Latest Breaking News From Ink World

    Xerox Board of Directors Names Steven Bandrowczak as CEO
    ALTANA AG to Sell Its Stake in dp polar to 3D Systems
    Weekly Recap: Zeller+Gmelin, Epple Druckfarben Lead This Week’s News Stories
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eukalin acquires Adhesives Specialists
    EyeC unveils new inspection products
    Errol Moebius named VP of IST America
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: A New Day for Hygiene, Glatfelter Reports Q2 Results & More
    Dyper Achieves B Corp Certification
    Edgewell’s Sales Grow
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OSSIO Rolls Out OSSIOfiber Suture Anchors in U.S.
    MicroPort Navibot’s SkyWalker System Cleared by FDA
    NuVasive Inc. Reports Q2 2022 Financial Results
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Infineon Technologies AG Offers Secured NFC Tags
    Universal Display Announces 2Q 2022 Financial Results
    Xerox Board of Directors Appoints Steven Bandrowczak as CEO

    Copyright © 2022 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