• 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
    Alleviant's Transcatheter Tech Obtains Breakthrough Status

    Signia Appoints New President

    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

    QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner

    MedAcuity, Fathom Partner on Human Factors Engineering Services
    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
    Spectrum Plastics Group

    Element

    Unicep

    MW Life Sciences

    FUTEK Advanced Sensor Technology Inc.
    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
    Unicep

    Qosina Corp.

    Creganna Medical, part of TE Connectivity

    Medbio LLC

    maxon
    • 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 Approves BD's HPV Test with Extended Genotyping Capabilities

    Only FDA-approved HPV assay to individually identify and report genotypes beyond 16, 18, and 45, according to BD.

    FDA Approves BD
    BD Onclarity HPV assay 3-well PCR reagent wells.
    Related CONTENT
    • New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
    • Urinary Tract Stent Market to Lose 11.4 Percent in Revenue Due to Coronavirus
    • BD Acquires CUBEX's Medical Business
    • The Lost Year: 2020 Year in Review
    • The Top 30 and M&A in 2021: What’s Next?
    PR Newswire07.22.20
    BD (Becton, Dickinson and Company) received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity HPV Assay. The PMA supplement includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 genotypes making the BD Onclarity HPV Assay the only FDA-approved assay to individually identify and report these genotype results.
     
    The value of extended genotyping for cervical cancer screening and triage has been reported from large clinical studies since 2015.1-8 Additionally, the need for expanded HPV genotyping for cervical screening has been recognized since 2016.9 In many cases, the reporting of HPV genotypes with the screening test result could improve risk stratification and support risk-based patient management. The April 2020 publication of the ASCCP risk-based management consensus guidelines anticipated that extended genotyping would be introduced soon.10
     
    "BD Onclarity™ extended genotyping is data-driven precision medicine at its best, helping us effectively and efficiently manage our patients," said Mark H. Stoler, MD Professor Emeritus of Pathology, University of Virginia Health System. "Contemporary management of women with abnormal cervical cancer screening results demands an assessment of their risk of pre-cancer. An abundance of recent science clearly shows that knowing the HPV genotype of the patient provides excellent differential stratification of those risks."1,4-8,11-13
     
    "It is well known that different HPV genotypes carry different risk of cervical cancer, and without the specific knowledge of the HPV genotype in a screening sample many women will be over-treated needlessly," said Jesper Bonde, PhD, Senior Researcher and Molecular Pathology Laboratory Manager, Hvidovre Hospital, Denmark.12 "Screening strategies that employ HPV tests with simultaneous genotyping offer a simple way to improve cervical cancer screening to the benefit of the woman and health care providers by allowing risk stratification already on the screening sample."
     
    The reporting of HPV genotypes with the screening tests and surveillance tests will facilitate same-genotype persistence tracking and risk-based management. A recent systematic review by Bottari et al concluded that, "evaluation of the HPV genotype persistence may represent a valid option to monitor patients treated for CIN 2+ lesions, because relapses were detected only in patients with persistence of the same genotype detected at baseline."11,13-15 
     
    "With this FDA approval, BD can now offer laboratories, clinicians and patients access to critical information in screening for cervical cancer in the United States and other countries recognizing the PMA supplement or CE mark," said Dave Hickey, president, Integrated Diagnostic Solutions at BD. "Our goal is to continue the global fight towards eliminating diseases and associated deaths due to cervical cancer with our comprehensive diagnostic solutions."
     
    References
    1 Wright, T. C., Jr. et al. Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance Population: Results of the Becton Dickinson Onclarity Trial. Am J Clin Pathol 151, 53-62, doi:10.1093/ajcp/aqy084 (2019).
    2 Schiffman, M. et al. A cohort study of cervical screening using partial HPV typing and cytology triage. International journal of cancer 139, 2606-2615, doi:10.1002/ijc.30375 (2016).
    3 Schiffman, M. et al. A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results. Gynecol Oncol 138, 573-578, doi:10.1016/j.ygyno.2015.06.040 (2015).
    4 Stoler, M. H. et al. HPV Testing With 16, 18, and 45 Genotyping Stratifies Cancer Risk for Women With Normal Cytology. American journal of clinical pathology 151, 433-442, doi:10.1093/ajcp/aqy169 (2019).
    5 Stoler, M. H. et al. The Onclarity Human Papillomavirus Trial: Design, methods, and baseline results. Gynecol Oncol 149, 498-505, doi:10.1016/j.ygyno.2018.04.007 (2018).
    6 Stoler, M. H. et al. Stratified risk of high-grade cervical disease using onclarity HPV extended genotyping in women, >/=25years of age, with NILM cytology. Gynecol Oncol 153, 26-33, doi:10.1016/j.ygyno.2018.12.024 (2019).
    7 Wright, T. C., Jr. et al. HPV infections and cytologic abnormalities in vaccinated women 21-34years of age: Results from the baseline phase of the Onclarity trial. Gynecol Oncol 153, 259-265, doi:10.1016/j.ygyno.2019.02.016 (2019).
    8 Wright, T. C., Jr. et al. Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, >/=21years of age, with ASC-US or LSIL cytology. Gynecol Oncol 154, 360-367, doi:10.1016/j.ygyno.2019.05.012 (2019).
    9 Cuzick, J. & Wheeler, C. Need for expanded HPV genotyping for cervical screening. Papillomavirus Res 2, 112-115, doi:10.1016/j.pvr.2016.05.004 (2016).
    10 Schiffman, M., Wentzensen, N., Perkins, R. B. & Guido, R. S. An Introduction to the 2019 ASCCP Risk-Based Management Consensus Guidelines. Journal of Lower Genital Tract Disease 24, 87-89, doi:10.1097/lgt.0000000000000531 (2020).
    11 Bottari, F. et al. Onclarity Human Papillomavirus Extended Genotyping in the Management of Cervical Intraepithelial Neoplasia 2+ Lesions. J Low Genit Tract Dis 23, 39-42, doi:10.1097/LGT.0000000000000441 (2019).
    12 Bonde, J. H., Sandri, M. T., Gary, D. S. & Andrews, J. C. Clinical Utility of Human Papillomavirus Genotyping in Cervical Cancer Screening: A Systematic Review. J Low Genit Tract Dis 24, 1-13, doi:10.1097/LGT.0000000000000494 (2020).
    13 Bottari, F. et al. Human Papillomavirus Genotyping Compared With a Qualitative High-Risk Human Papillomavirus Test After Treatment of High-Grade Cervical Intraepithelial Neoplasia: A Systematic Review. Obstet Gynecol 134, 452-462, doi:10.1097/AOG.0000000000003409 (2019).
    14 Bottari, F. & Iacobone, A. D. Profile of the BD HPV OnclarityTM assay. Expert review of molecular diagnostics 19, 565-570, doi:10.1080/14737159.2019.1622415 (2019).
    15 Einstein, M. H. Precision Screening for Posttreatment Surveillance. Obstetrics & Gynecology 134, 1-2 (2019).
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    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
    Urinary Tract Stent Market to Lose 11.4 Percent in Revenue Due to Coronavirus Urinary Tract Stent Market to Lose 11.4 Percent in Revenue Due to Coronavirus
    BD Acquires CUBEX BD Acquires CUBEX's Medical Business
    The Lost Year: 2020 Year in Review The Lost Year: 2020 Year in Review
    The Top 30 and M&A in 2021: What’s Next? The Top 30 and M&A in 2021: What’s Next?
     How COVID-19 is Reshaping the Diagnostics Testing Sector How COVID-19 is Reshaping the Diagnostics Testing Sector
    Quasar Medical Devices Expands Headquarters Quasar Medical Devices Expands Headquarters
    BD Makes Executive Leadership Appointments BD Makes Executive Leadership Appointments
    OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test
    BD BD's SARS-CoV-2 Antigen Test OKed in Europe
    Cepheid Cepheid's Combo COVID-19, Flu A/B, RSV Test Earns EUA
    Vela Diagnostics Vela Diagnostics' SARS-CoV-2 RT-PCR Test v2.0 Earns EUA
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    Eurobio Scientific Launches Rapid Dx Test for SARS CoV-2 Virus Antigen Eurobio Scientific Launches Rapid Dx Test for SARS CoV-2 Virus Antigen
    UK Study Reveals the Accuracy of a 90-Minute COVID-19 Test UK Study Reveals the Accuracy of a 90-Minute COVID-19 Test

    Related Breaking News

    • 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

    • Diagnostics
      CareDx Partners with IDbyDNA

      CareDx Partners with IDbyDNA

      Will develop AlloID, a transplant patient-specific metagenomic infectious disease test platform.
      Globe Newswire 01.08.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    Breaking News
    • Alleviant's Transcatheter Tech Obtains Breakthrough Status
    • Signia Appoints New President
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    • MedAcuity, Fathom Partner on Human Factors Engineering Services
    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

    Oleic Acid Possibly Implicated in MS Pathology
    NIH Study Compares Low-Fat, Plant-Based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Coatings World

    Latest Breaking News From Coatings World

    APV Engineered Coatings Reflects on 2020
    LINE-X Launches Dealer Program with International Truck
    PPG Donates Coatings, Sealants to Help Restore Douglas C-54 Skymaster Aircraft
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Alleviant's Transcatheter Tech Obtains Breakthrough Status
    Signia Appoints New President
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia
    Humanigen, Emergent Enter Covid-19 Partnership
    Samsung Bioepis Opens New Headquarters
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Fitglow Beauty Wins Big at Annual Dirty Thinker’s Choice Awards
    e.l.f. Cosmetics Unveils Mint Melt Collection
    Estée Lauder Companies Updates Supply Chain Leadership
    Happi

    Latest Breaking News From Happi

    Curcumin's Role in Oral Care
    Degree Launches Bath and Shower Range
    Estée Lauder Companies Updates Supply Chain Leadership
    Ink World

    Latest Breaking News From Ink World

    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    VPF launches deep-freeze adhesive
    ProMach strengthens flexible packaging business
    Gallus planning virtual event for March
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System
    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    Imec Technology Taking Off to Space
    Osram in Top 25 of World’s 100 Most Sustainable Companies

    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