• 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
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    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
    New Breast Implant Surgery Guidelines to Enhance Patient Safety

    Rhythm Management Group Debuts RhythmSynergy Tech Platform

    FDA Approves Trial Completion for Virtual Incision's MIRA Platform

    Thermo Fisher Scientific, Matrix Clinical Trials Enhance Research Solutions

    Medtronic, DaVita to Create New Kidney Care Firm
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    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.

    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Trademark Plastics Inc.

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Xact Wire EDM Corp.

    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Trademark Plastics Inc.

    Cirtec Medical
    • 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

    Cepheid Earns FDA Clearance and CLIA Waiver for Xpert Xpress Flu/RSV Test

    The test provides respiratory infection results in as little as 20 minutes.

    Cepheid Earns FDA Clearance and CLIA Waiver for Xpert Xpress Flu/RSV Test
    According to the World Health Organization, infections of the upper respiratory tract represent the most common reason for antimicrobial use. Image courtesy of Cepheid.
    Related CONTENT
    • RedDress’ ActiGraft System Receives New FDA Clearance
    • Quanta Raises $245 Million in Series D Funding Round
    • Rehabtronics’ Prelivia Neurostimulation Device Cleared by FDA
    • FDA OKs Rehabtronics' Prelivia to Protect from Pressure Injuries
    • EchoNous’ Lexsa Linear Probe Cleared by FDA
    PR Newswire07.26.18
    Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert Xpress Flu/RSV test. The test can be performed in near-patient settings, providing rapid and accurate molecular detection of influenza A and B viruses, and RSV RNA from patient specimens in as little as 20 minutes.1
     
    In addition to nasopharyngeal (NP) swab specimens, the Xpert Xpress Flu/RSV test is indicated for use with nasal swabs. Nasal swab collection is less invasive than NP swabs are and allows for a more comfortable specimen collection experience for the patient.
     
    "Reflecting on the enormous impact of the last flu season, we are pleased to announce the launch of Cepheid's third CLIA-waived respiratory test: Xpert Xpress Flu/RSV. Our family of CLIA-waived Xpert Xpress tests allows laboratories to expand their capacity by extending standardized testing for flu, RSV, and Strep A to near-patient and point-of-care settings. Our first-in class multi-module system deals effectively with the surge of tests demanded by a severe flu season and frees up the laboratory to conduct other more complicated tests," said David H. Persing, M.D., Ph.D., Cepheid's chief medical and technology officer.
     
    According to the World Health Organization, infections of the upper respiratory tract represent the most common reason for antimicrobial use. The vast majority of such infections are of viral origin and do not require treatment with antimicrobials.2 "Xpert Xpress Flu/RSV, Flu, and Strep A tests provide medically actionable and timely information to clinicians to support improved patient management, and antibiotic and antiviral stewardship," continued Dr. Persing.
     
    Xpert Xpress Flu/RSV utilizes automated real-time reverse transcription polymerase chain reaction (RT-PCR) to detect influenza A, influenza B, and RSV RNA. The test's capability to detect multiple segments of RNA improves strain coverage and prevents loss of sensitivity as natural variations (antigenic drift and shift) of the influenza virus occur. The onboard reagents deliver high-performance specifications with no additional confirmation testing required.
     
    References
    1 With early assay termination (EAT) for positive Flu or for positive RSV only. Reporting negatives and combined Flu and RSV results in 30 minutes.
    2 World Health Organization. Upper respiratory tract infections. Accessed June 2018. http://apps.who.int/medicinedocs/en/d/Js5406e/3.html
    Related Searches
    • nasal
    • rna
    • medical
    • u.s. food and drug administration
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    RedDress’ ActiGraft System Receives New FDA Clearance RedDress’ ActiGraft System Receives New FDA Clearance
    Quanta Raises $245 Million in Series D Funding Round Quanta Raises $245 Million in Series D Funding Round
    Rehabtronics’ Prelivia Neurostimulation Device Cleared by FDA Rehabtronics’ Prelivia Neurostimulation Device Cleared by FDA
    FDA OKs Rehabtronics FDA OKs Rehabtronics' Prelivia to Protect from Pressure Injuries
    EchoNous’ Lexsa Linear Probe Cleared by FDA EchoNous’ Lexsa Linear Probe Cleared by FDA
    Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades
    FDA Clears 3NT Medical’s Peregrine Drivable ENT Scope FDA Clears 3NT Medical’s Peregrine Drivable ENT Scope
    FDA OKs SpinTech FDA OKs SpinTech's STAGE MRI Software
    FDA OKs QTc Interval Measurement for AliveCor FDA OKs QTc Interval Measurement for AliveCor's Personal ECG
    First U.S. Ischemic Stroke Patients Treated With Rapid Medical’s Clot Retriever First U.S. Ischemic Stroke Patients Treated With Rapid Medical’s Clot Retriever
    Nuvo Nuvo's Remote Uterine Monitoring Earns FDA Nod
    Getinge Receives FDA Clearance for Multiple Products Getinge Receives FDA Clearance for Multiple Products
    Acutus Medical Receives FDA Clearance of AcQCross Acutus Medical Receives FDA Clearance of AcQCross
    Digging into the Cardiac Arrhythmia Monitoring Device Market Digging into the Cardiac Arrhythmia Monitoring Device Market
    Four Considerations When Selling to a Private Equity Fund Four Considerations When Selling to a Private Equity Fund

    Related Content

    • RedDress’ ActiGraft System Receives New FDA Clearance

      RedDress’ ActiGraft System Receives New FDA Clearance

      ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.
      Globe Newswire 09.22.21

    • Quanta Raises $245 Million in Series D Funding Round

      Quanta Raises $245 Million in Series D Funding Round

      Money will help accelerate the commercialization of the company's SC+ Portable Hemodialysis System.
      Business Wire 09.10.21

    • Rehabtronics’ Prelivia Neurostimulation Device Cleared by FDA

      Rehabtronics’ Prelivia Neurostimulation Device Cleared by FDA

      Promotes healthy blood circulation and maintains healthy tissue in people who are bedridden or chair bound.
      Rehabtronics


    • Neurological
      FDA OKs Rehabtronics

      FDA OKs Rehabtronics' Prelivia to Protect from Pressure Injuries

      Neurostim device protects patients from pressure injuries at hospitals and care homes.
      PR Newswire 09.01.21

    • Diagnostics
      EchoNous’ Lexsa Linear Probe Cleared by FDA

      EchoNous’ Lexsa Linear Probe Cleared by FDA

      An ultra-portable device capable of producing diagnostic-quality images rivaling those from larger, more expensive cart-based units.
      EchoNous 08.19.21


      Trending
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status | Medical Product Outsourcing
      • FDA Clears Masimo's Neonatal RD SET Pulse Oximetry Sensors With Improved Accuracy Specifications | Medical Product Outsourcing
      • Medtronic, DaVita To Create New Kidney Care Firm | Medical Product Outsourcing
      • 7 Steps To Create Your Own Medical Device Marketing Plan | Medical Product Outsourcing
      Breaking News
      • New Breast Implant Surgery Guidelines to Enhance Patient Safety
      • Rhythm Management Group Debuts RhythmSynergy Tech Platform
      • FDA Approves Trial Completion for Virtual Incision's MIRA Platform
      • Thermo Fisher Scientific, Matrix Clinical Trials Enhance Research Solutions
      • Medtronic, DaVita to Create New Kidney Care Firm
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      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

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      Nippon Paint Automotive Americas Appoints Robert Angart CEO and President
      Sustainability, Economy are Focus of BCF’s Annual Conference
      Demand for Rhino Shield Increases
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      New Breast Implant Surgery Guidelines to Enhance Patient Safety
      Rhythm Management Group Debuts RhythmSynergy Tech Platform
      FDA Approves Trial Completion for Virtual Incision's MIRA Platform
      Contract Pharma

      Latest Breaking News From Contract Pharma

      iECURE Enters Agreement with Center for Breakthrough Medicines
      CPDC Enters Clinical Manufacturing Deal with CellBion
      Olon to Build New R&D Center in Italy
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      K-Beauty Brand Siita Shares Plastic Decomposition Technology with the Beauty Industry
      Shellworks Raises $6.2 Million in Seed Funding
      Ulta Beauty Reports Record First Quarter 2022 Results
      Happi

      Latest Breaking News From Happi

      Honeywell Addresses Critical Issues Such as Sustainability, Workforce Training and Digitalization
      Monat Global Wins Four Stevie Awards in the 20th Annual American Business Awards
      Coty Expands Vegan Beauty Portfolio With New Rimmel Mascara
      Ink World

      Latest Breaking News From Ink World

      Orion to Finish Gas Black Expansion in Germany by Early 2023
      Richard Childress Racing Shows Off New Wraps for 2022 NASCAR Season
      ProAmpac Acquires Specialty Packaging, Inc.
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      UPM Raflatac accelerates label growth with acquisition
      Labelexpo Asia 2022 postponed
      Teklynx software helps Top Clean Injection validate labels
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Toetal Solutions Raises $1.02 Million in New Financing
      ManaMed's ManaSport Wearable Ultrasound Earns FDA Nod
      Ekso Bionics Names Jerome Wong as Interim CFO
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      SEMI Foundation Receives $1.5 Million Grant to Bolster Michigan’s Semiconductor Talent Pipeline
      onsemi Recognized by Fortune 500 for Its Transformation Journey
      LG Display Presents AI-Driven NFT Artwork on Transparent OLED

      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