• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Cold Chain Packaging and Logistics

    How Artificial Intelligence and Machine Learning are Transforming the Life Sciences

    Challenges of Preparing Highly Potent Oral Products

    Bioprocessing Trends

    Sustainable Manufacturing
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Pasithea Signs CMC Development and Manufacturing Agreement

    Experic Expands Analytical Capabilities and Facilities

    List Labs Expands Manufacturing Capacity

    groninger Continues Growth in the US

    Catalent Bolsters Cell and Gene Services
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    What Does the Future of API Synthesis Look Like?

    Pasithea Signs CMC Development and Manufacturing Agreement

    Experic Expands Analytical Capabilities and Facilities

    List Labs Expands Manufacturing Capacity

    Jaguar Health Achieves Key Milestone for Crofelemer API Manufacturer
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Catalent Bolsters Cell and Gene Services

    CDMO Sirio Pharma Completes the Acquisition of Best Formulations

    Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1

    Case Study: Secondary Sourcing Strategies to Ensure Supply Chain Security

    Beat the Supply Chain Backlog
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Experic Expands Analytical Capabilities and Facilities

    List Labs Expands Manufacturing Capacity

    Catalent Bolsters Cell and Gene Services

    Crown Bioscience to Acquire Indivumed’s Service Biz and Supporting Biobank

    Stevanato Group, Transcoject Partner on Pre-Fillable Syringe Polymer Options
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Adare Partners with Veeva to Strengthen Quality Operations

    KBI Secures Swissmedic Regulatory Establishment License for Facility in Geneva

    Enhancing Ease of Use, Batch Turnaround, and Process Flexibility

    Understanding the Essential Role of a Qualified Person

    Altasciences Los Angeles Clinical Site Receives CAP Accreditation
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    LOTTE BIOLOGICS

    Chiron Recombinant Proteins

    BioIVT

    Lannett CDMO

    Quotient Sciences
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    LOTTE BIOLOGICS

    Chiron Recombinant Proteins

    BioIVT

    Lannett CDMO

    Quotient Sciences
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • White Papers
    • Podcasts
    • Infographics
    • Microsites
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    Thermo Fisher Gets Expanded EUA for SARS‑CoV‑2 Test

    This third expansion further increases the number of high-throughput PCR instruments that labs can use to run tests.

    Related CONTENT
    • Sekisui
    • Thermo Fisher Launches Gibco AAV Production System
    • Thermo Fisher, AstraZeneca Collaborate on NGS-Based Companion Diagnostics
    • Thermo Scientific Launches iCAP PRO Series
    • Thermo Fisher Scientific Launches Heracell Vios CR CO2 Incubator
    Contract Pharma Staff05.13.20
    Thermo Fisher Scientific Inc. received expanded emergency use authorization (EUA) from the FDA for its multiplex real-time PCR test for the qualitative detection of nucleic acid from SARS‑CoV‑2, the virus that causes COVID-19.

    Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, initially granted EUA on March 13 and subsequently expanded on April 20, is designed to deliver test results within four hours of a sample being received and processed by a CLIA high-complexity lab. This third expansion further increases the number of high-throughput PCR instruments that labs can use to run tests and also provides new options for reagents and consumables used in sample preparation and extraction to provide greater flexibility in testing workflows.

    In addition to the previously approved Applied Biosystems 7500 Real-time PCR series and a version of the Applied Biosystems QuantStudio 5, labs can now run tests on specific configurations of QuantStudio 7 Flex and QuantStudio 5 Real‑time PCR instruments, contributing significantly to the number of instruments available for testing.

    This expanded EUA also increases the availability of RNA extraction reagents by adding the company's MagMAX viral/pathogen II nucleic isolation kit as an alternative. Additionally, the sample purification step has been updated to allow a variety of microplate options.
    Related Searches
    • Laboratory Testing
    Suggested For You
    Sekisui Sekisui
    Thermo Fisher Launches Gibco AAV Production System Thermo Fisher Launches Gibco AAV Production System
    Thermo Fisher, AstraZeneca Collaborate on NGS-Based Companion Diagnostics Thermo Fisher, AstraZeneca Collaborate on NGS-Based Companion Diagnostics
    Thermo Scientific Launches iCAP PRO Series Thermo Scientific Launches iCAP PRO Series
    Thermo Fisher Scientific Launches Heracell Vios CR CO2 Incubator Thermo Fisher Scientific Launches Heracell Vios CR CO2 Incubator
    Thermo Fisher Scientific Opens New Plasmid DNA Manufacturing Facility Thermo Fisher Scientific Opens New Plasmid DNA Manufacturing Facility
    Thermo Fisher Names New Chief Medical Officer Thermo Fisher Names New Chief Medical Officer
    Thermo Fisher Scientific Expands Gene Therapy Portfolio Thermo Fisher Scientific Expands Gene Therapy Portfolio
    Thermo Scientific Upgrades Ultra-Low Temperature Freezers Thermo Scientific Upgrades Ultra-Low Temperature Freezers
    Moderna, Thermo Fisher Enter COVID Vax Fill/Finish Mfg. Pact Moderna, Thermo Fisher Enter COVID Vax Fill/Finish Mfg. Pact
    Sterling Pharma Appoints Stewart Mitchell as New Site Head Sterling Pharma Appoints Stewart Mitchell as New Site Head
    Thermo Fisher, UCSF to Open Cell Therapy cGMP Mfg. Center Thermo Fisher, UCSF to Open Cell Therapy cGMP Mfg. Center
    Thermo Fisher Acquires PPD for $17.4B Thermo Fisher Acquires PPD for $17.4B
    Vibalogics Updates U.S. Leadership Team Vibalogics Updates U.S. Leadership Team
    Thermo Fischer Scientific Collaborates with Protein Metrics Thermo Fischer Scientific Collaborates with Protein Metrics

    Related Buyers Guide Companies

    • Sekisui

      ...
      Jim Alferman, Associate Director, Business Development 11.08.22

    • Biologics, Proteins, Vaccines | Reader Showcase
      Thermo Fisher Launches Gibco AAV Production System

      Thermo Fisher Launches Gibco AAV Production System

      Aims to address the need to make adeno-associated virus (AAV) production more efficient and scalable.
      09.20.21

    • Breaking News | Collaborations & Alliances
      Thermo Fisher, AstraZeneca Collaborate on NGS-Based Companion Diagnostics

      Thermo Fisher, AstraZeneca Collaborate on NGS-Based Companion Diagnostics

      Aim to accelerate development and introduction of targeted precision medicine therapies for patients.
      09.02.21


    • Laboratory Testing | Reader Showcase
      Thermo Scientific Launches iCAP PRO Series

      Thermo Scientific Launches iCAP PRO Series

      Designed to provide a fast, sensitive range of trace element analysis solutions capable of capturing the complete spectrum of high matrix samples in single run.
      07.23.21

    • Biologics, Proteins, Vaccines | Drug Development | Reader Showcase
      Thermo Fisher Scientific Launches Heracell Vios CR CO2 Incubator

      Thermo Fisher Scientific Launches Heracell Vios CR CO2 Incubator

      First-in-market CO2 incubator combines optimal cell growth capabilities with certified cleanroom compatibility.
      07.21.21

    Loading, Please Wait..
    Trending
    • Sarepta And Catalent Expand Manufacturing Partnership
    • Forge Biologics Strengthens Genetic Medicine CDMO Capabilities
    • Colorcon Signs Agreement To Purchase Airnov Healthcare Packaging
    • The Ongoing Evolution And Implementation Of DCTs In 2023
    • EyePoint Pharmaceuticals To Build GMP Mfg. Facility In Northbridge, MA
    Breaking News
    • Pasithea Signs CMC Development and Manufacturing Agreement
    • Experic Expands Analytical Capabilities and Facilities
    • List Labs Expands Manufacturing Capacity
    • groninger Continues Growth in the US
    • Catalent Bolsters Cell and Gene Services
    View Breaking News >
    CURRENT ISSUE

    November/December 2022

    • Cold Chain Packaging and Logistics
    • Optimizing Supply Chains for Allogeneic Cell Therapy Trials
    • Sustainable Manufacturing
    • Bioprocessing Trends
    • How Artificial Intelligence and Machine Learning are Transforming the Life Sciences
    • 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

    Vitamin D Supplementation Reduces Risk of Dynapenia
    Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits
    Multi-Strain Probiotic Improves Self-Reported Mood, Sleep, Serotonin Levels
    Coatings World

    Latest Breaking News From Coatings World

    Epoxytec Announces New Website Launch
    Paints and Coatings Market Worth $212B by 2026: MarketsandMarkets
    Axalta Releases Fourth Quarter and Full Year 2022 Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    BMP Medical Expands Sterling, Massachusetts Facility
    Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy
    Environmental Sustainability Becoming Increasingly Important to Medtech Industry
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pasithea Signs CMC Development and Manufacturing Agreement
    Experic Expands Analytical Capabilities and Facilities
    List Labs Expands Manufacturing Capacity
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Haircare Brand Uncle Funky’s Daughter Announces Retail Expansion
    TRESemmé Introduces New Pro Infusion Collection
    Walgreens Boots Alliance Shares 2022 ESG Report
    Happi

    Latest Breaking News From Happi

    KimChi Beauty Launches Spinning Hearts Love 02 Ahead of Valentine’s Day
    Dark & Lovely Names Actress Meagan Good Brand Ambassador
    Natural Household Care Company Tru Earth Adds Dishwasher Detergent Tablets
    Ink World

    Latest Breaking News From Ink World

    Xerox Releases 4Q, Full-Year 2022 Results
    Electronics For Imaging Names Frank Pennisi as CEO
    Fiery to Separate from EFI, Remain Wholly-Owned by Siris
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    EFI appoints Frank Pennisi CEO, Fiery now an independent business
    Bobst boosts senior sales team with Keith Nagle
    Penmar Industries adds Screen Truepress Jet L350UV SAI digital press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Essity’s Sales Grow
    Thinx to Pay up to $5 million to Settle Class Action Suit
    Typar Highlighting New Building Innovations
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Launches the Mariner Deformity System
    Tyber Medical Hires 2 New Execs
    Miach Ortho Raises $40M in Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Smart Devices with Privacy Focus Have More Consumer Appeal
    Siman Group Partners with SML to Unlock Full Retail Potential with RFID
    Brewer Science Presents Optics Integration Solutions at SPIE Photonics West

    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