• 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
    Butterfly Network Appoints New Leader

    BD Names Chairman of Board

    Interplex Acquires OCP Group

    FDA Clears a Portable Hemodialysis System

    Solid Growth Forecast for India's HER2 Amplification Tests Market
    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
    Qosina Corp.

    maxon

    FUTEK Advanced Sensor Technology Inc.

    Medbio LLC

    Medicoil
    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
    MW Life Sciences

    Creganna Medical, part of TE Connectivity

    Qosina Corp.

    PTI Engineered Plastics Inc.

    Concise Engineering
    • 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 Expands Authorization of Hologic Aptima COVID-19 Test

    Now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.

    FDA Expands Authorization of Hologic Aptima COVID-19 Test
    Aptima SARS-CoV-2 assay to include COVID-19 testing of asymptomatic individuals, symptomatic sample pooling. Image courtesy of Business Wire.
    Related CONTENT
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    • Endoscopic Hemostasis Devices Market Valued at $730 Million
    • Henry Schein Buys Majority Interest in Prism Medical Products
    • Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection
    Business Wire10.07.20
    Hologic Inc.’s Aptima SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May, is now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.
     
    This authorization follows an announcement last week of similar claims for Hologic’s Panther Fusion SARS-CoV-2 assay. The U.S. Centers for Disease Control and Prevention (CDC) recently issued guidance recommending COVID-19 tests for people who have had recent contact with infected individuals, a key strategy for limiting the spread of the virus.1
     
    “For many years, molecular tests—tests that directly detect the genetic material of pathogens—have been recognized as the gold standard for infectious disease diagnostics,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “They remain the most sensitive and accurate available options, which is particularly important when screening individuals with no symptoms or known contact with infected people, and therefore no clues about their infectious state."
     
    The asymptomatic screening claim is based on available analytical data, including results published in a recent FDA report, as well as Hologic’s commitment to submit results from a clinical evaluation currently in progress. The FDA report showed that Hologic’s assays are the most analytically sensitive of the fully automated, high-throughput molecular tests on the market.
     
    In addition, FDA authorized the company’s pooling protocol for symptomatic testing with the Aptima SARS-CoV-2 assay.
     
    To date, Hologic has produced tens of millions of SARS-CoV-2 assays, thereby making a significant contribution to the global testing supply. The Aptima and Panther Fusion SARS-CoV-2 tests run on Hologic’s fully automated Panther and Panther Fusion systems, respectively, each of which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. More than 2,000 Panther and Panther Fusion systems have been installed in clinical diagnostic laboratories around the world.
     
    References
    1 https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html. Accessed September 27, 2020.
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    Endoscopic Hemostasis Devices Market Valued at $730 Million Endoscopic Hemostasis Devices Market Valued at $730 Million
    Henry Schein Buys Majority Interest in Prism Medical Products Henry Schein Buys Majority Interest in Prism Medical Products
    Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection
    Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S. Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.
    Olympus and Hitachi Sign Five-Year Contract Olympus and Hitachi Sign Five-Year Contract
    Acutus Medical Launches AcQCross Transseptal System in Europe Acutus Medical Launches AcQCross Transseptal System in Europe
    New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
    BioSerenity Achieves FDA Clearance for Wearable Device System BioSerenity Achieves FDA Clearance for Wearable Device System
    Hermetic Solutions Acquires Cristek Interconnects Hermetic Solutions Acquires Cristek Interconnects
    Greenlight Guru and Nelson Labs Partner Greenlight Guru and Nelson Labs Partner
    Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe
    Hologic to Buy Cancer Test Maker Biotheranostics for $230M Hologic to Buy Cancer Test Maker Biotheranostics for $230M
    Katena Products Welcomes New CEO Katena Products Welcomes New CEO

    Related Breaking News

    • Diagnostics
      Abbott

      Abbott's Panbio Rapid COVID-19 Antigen Test Earns CE Mark for Two New Uses

      EU approves symptomatic screening and self-administered sample collection with nasal swab.
      Sam Brusco, Associate Editor 01.26.21

    • Diagnostics
      FDA OKs Canon Medical

      FDA OKs Canon Medical's AI-Powered, 90cm Bore CT

      Company claims the Aquilion Exceed LB CT offers the industry's largest bore opening.
      Sam Brusco, Associate Editor 01.21.21

    • Diagnostics
      RSIP Vision Announces Versatile Medical Image Segmentation Tool

      RSIP Vision Announces Versatile Medical Image Segmentation Tool

      Delivers efficient anatomical measurements and better treatment options.
      RSIP Visions 01.20.21


    • Diagnostics
      Thermo Fisher Buys Mesa Biotech for $450M

      Thermo Fisher Buys Mesa Biotech for $450M

      Mesa Biotech developed, commercialized a PCR-based rapid POC testing platform for detecting infectious diseases.
      PR Newswire 01.20.21

    • Diagnostics
      Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases

      Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases

      Supports research to distinguish between different types of chronic inflammatory airway diseases.
      Owlstone Medical 01.19.21

    • Cardiovascular | Diagnostics
      FDA OKs MRI for Impulse Dynamics

      FDA OKs MRI for Impulse Dynamics' Optimizer CCM Delivery Systems

      FDA clears potential hurdle for many heart failure patients.
      Business Wire 01.19.21


    • Diagnostics
      Rapid Antigen Tests Manufacturer Acquires BIOLAB

      Rapid Antigen Tests Manufacturer Acquires BIOLAB

      Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.
      Innova Medical Group Inc. 01.14.21

    • Diagnostics
      PerkinElmer

      PerkinElmer's SARS-CoV-2 RT-PCR Assay Earns EUA for Asymptomatic Testing

      Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread.
      Business Wire 01.14.21

    • Diagnostics
      High-Volume COVID Antigen Test Receives FDA EUA

      High-Volume COVID Antigen Test Receives FDA EUA

      Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.
      Ortho Clinical Diagnostics 01.13.21


    • Diagnostics
      Researchers Develop Chip That Can Detect COVID-19 Antibodies in a Minute

      Researchers Develop Chip That Can Detect COVID-19 Antibodies in a Minute

      New diagnostic platform could be a valuable tool for detecting exposure to multiple viruses.
      Bob Marcotte, University of Rochester 01.13.21

    • Diagnostics
      Abbott to Supply Additional 30M COVID-19 Tests to U.S. Gov

      Abbott to Supply Additional 30M COVID-19 Tests to U.S. Gov't

      Company is in final stages of completing its self-funded capacity expansion across U.S. manufacturing sites.
      PR Newswire 01.13.21

    • Diagnostics
      Olympus and Hitachi Sign Five-Year Contract

      Olympus and Hitachi Sign Five-Year Contract

      Will jointly develop Endoscopic Ultrasound Systems.
      Olympus Corporation 01.11.21


    • Diagnostics
      ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test

      ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test

      Provides fast, accurate, and easy-to-interpret test results.
      PRNewswire 01.11.21

    • Diagnostics | Neurological
      FDA OKs Abbott

      FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test

      Produces a result within 15 minutes after a plasma sample is inserted.
      Abbott Laboratories 01.11.21

    • Diagnostics
      SARS-CoV-2 Mutation Prompts FDA Alert

      SARS-CoV-2 Mutation Prompts FDA Alert

      Impact remains low, but false negative results can occur with any molecular test.
      U.S. Food and Drug Administration 01.11.21


    Trending
    • Senseonics Forges Strategic Collaboration With Ascensia Diabetes Care
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Henry Schein Buys Majority Interest In Prism Medical Products
    • Top 10 Trends In The Medical Device And Equipment Industry
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    Breaking News
    • Butterfly Network Appoints New Leader
    • BD Names Chairman of Board
    • Interplex Acquires OCP Group
    • FDA Clears a Portable Hemodialysis System
    • Solid Growth Forecast for India's HER2 Amplification Tests Market
    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

    Omega-3s Evidenced to Reduce Low-Grade Inflammation in Elderly Men
    MIND and Mediterranean Diets Linked to Later Onset of Parkinson’s Disease
    Kerry Launches Web-Based Tool for Plant-Based Formulation Challenges
    Coatings World

    Latest Breaking News From Coatings World

    Keyland Polymer UV Powder, LLC Launches UVMax Defender
    Scott McLaughlin to Race in PPG Colors During Rookie INDYCAR Season
    Vink Chemicals Offers parmetol PSG
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Butterfly Network Appoints New Leader
    BD Names Chairman of Board
    Interplex Acquires OCP Group
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Adare Pharma Solutions Opens New Small-Scale Lab
    Stevanato Group Launches After-sales Service Offering
    X-Chem Acquires IntelliSyn and AviSyn
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Estée Lauder Companies Announces Game-Changing Sustainability Goals for Travel Retail
    Aura Introduces Customizable Hair Care
    Corpack Creates Custom Packaging for Marlies Möller Hair Care Line
    Happi

    Latest Breaking News From Happi

    Nice-Pak Receives EPA Approval for Disinfectant Wipes
    FDA Takes Major Action on Hand Sanitizers from Mexico
    Symrise Shares 2020 Sales Figures
    Ink World

    Latest Breaking News From Ink World

    Epson Partner Creates Label Applicators for Pharmaceutical Products
    Smurfit Kappa Sets New Sustainability Targets with Better Planet 2050
    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Great Lakes Label debuts new website
    Epson partner creates label applicators for pharmaceutical products
    ACTEGA removes chemicals from laminating adhesives
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    American Made Production Equipment for Mask Manufacturers
    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Spinal Elements' Lucent XP-Curved Expandable TLIF Gains FDA Nod
    FDA OKs OrthoSpin's 2nd Gen Robotic, Digital External Fixation System
    Nextremity Solutions Enters Supply Agreement with Fort Wayne Metals
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    North American Semiconductor Equipment Industry Posts December 2020 Billings
    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    PRINTING United Alliance Announces TAGA Presents Virtual Event

    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