Corporate Banner
Satellite Banner
qPCR
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

FDA Recommends Roche's HPV Test as Primary Screening Tool

Published: Thursday, March 13, 2014
Last Updated: Thursday, March 13, 2014
Bookmark and Share
Test will assess risk of cervical cancer of women 25 years and older.

The FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV (Human Papillomavirus) Test as a first line, primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks. The panel also voted unanimously that the cobas HPV Test is safe and effective for the proposed indication for use. If approved, the cobas HPV Test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the United States.

“Every year, 12,000 women are diagnosed in the U.S. with cervical cancer. This is especially tragic because cervical cancer is a largely preventable disease, and it is well established that HPV is the cause of almost all cervical cancers worldwide. Women need better access to screening tools that include primary HPV screening in order to reduce their risk of developing cervical cancer,” said Dr. Thomas C. Wright, Jr., Professor Emeritus of Pathology and Cell Biology, Columbia University Medical Center, NY. “I am pleased that the FDA panel recognized the importance of validated, scientific evidence documenting the use of primary HPV screening to detect women at risk of invasive cervical cancer and allow us to prevent cervical cancer from developing.”

HPV causes more than 99 percent of cervical cancers and HPV genotypes 16 and 18 cause 70 percent of these cases worldwide. For decades, women have relied on cytology to detect evidence of disease. The ATHENA study, which included more than 47,000 women, showed that a significant number of women would benefit by using the cobas HPV Test as primary screening for cervical cancer. In fact, ATHENA demonstrated that nearly 1 in 7 women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.

“Through technological and scientific advancement, we now have a better screening tool for cervical cancer. Women around the world deserve the best tool to know their risk and reduce their chances of developing cervical cancer,” said Roland Diggelmann, COO Division Roche Diagnostics. “We look forward to working with the FDA and medical community to support the growing understanding and awareness of the role that HPV plays in cervical disease, and the importance of the cobas HPV Test, which provides the necessary medical benefit to become the first line test in a cervical cancer screening strategy. ”

The Committee's recommendation will be considered by the FDA in its review of the primary screening indication for the cobas HPV Test. The FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing medical devices.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Roche Receives FDA Clearance for Strep A Test
The cobas Strep A test is the first molecular point of care test to provide a result in 15 minutes for this common infection.
Friday, November 14, 2014
Roche Acquires IQuum
Acquisition will allow Roche to quickly enter the point of care segment of molecular diagnostics.
Monday, April 07, 2014
Roche Signs Licensing Agreement with Sysmex Inostics
Under the terms of the agreement, Roche grants Sysmex a worldwide, non-exclusive, royalty-bearing license.
Friday, February 21, 2014
Roche’s MycoTOOL Receives Acceptance from Canadian Authorities
PCR test reduces time for mycoplasma detection from one month to one day.
Friday, June 14, 2013
Roche and Life Technologies Corporation Sign New PCR IVD Licenses
Companies announced that they have entered into two license agreements to allow LTC to expand its PCR offerings for diagnostics applications.
Thursday, February 23, 2012
Hamilton Introduces Automated DNA Sample Enrichment Solution
System uses Roche 454 REM e liquid handling system to replace hours of manual work.
Tuesday, January 31, 2012
Roche’s Novel Tests for the Management of Hepatitis C Virus Infection Receive CE Mark
The tests detect HCV RNA, which is a crucial marker in the management of hepatitis C infection.
Tuesday, January 17, 2012
Roche and Labcyte Integrate Echo and LightCycler Systems to Increase Performance of qPCR-based RNA/DNA Analyses
Companies cooperate around high-speed, miniaturized quantitative PCR (qPCR) to monitor the expression of tens to thousands of genes for therapeutic research.
Wednesday, December 07, 2011
Roche Signs Exclusive Agreement with IT-IS Life Sciences
Agreement to distribution the new LightCycler® Nano Instrument, which will complete the company´s portfolio for the low throughput real-time PCR systems market.
Monday, May 30, 2011
Roche and Lonza Enter into Distribution Agreement
Roche and Lonza have announced that they have entered into a co-exclusive distribution agreement for the commercialization of Roche’s MycoTOOL mycoplasma PCR assays.
Wednesday, April 13, 2011
Roche and Lonza Enter into MycoTOOL Distribution Agreement for Rapid Mycoplasma Testing Solutions
MycoTOOL test is the first commercial NAT-based detection system used for mycoplasma biosafety testing of approved biological products.
Wednesday, April 13, 2011
Roche Obtains Co-Exclusive License to Develop PCR Assays Detecting Mutations in the PI3K Oncogene
The assay will complement Roche's menu in development of assays for validated biomarkers, including the B-RAF V600E mutation.
Wednesday, July 14, 2010
Ghent University will Use Roche's LightCycler® 1536 Instrument in the Field of HT PCR for Cancer Research
Roche and Ghent University enter agreement for the use of Roche's LightCycler® 1536 Instrument in various cancer research projects in Ghent.
Thursday, April 22, 2010
FDA Grants Emergency Use Authorization to Roche’s Assay for 2009 H1N1 Influenza Virus
Roche’s RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization from the FDA.
Tuesday, November 17, 2009
Online Configuration of Custom qPCR Assays and Panels Now Available with RealTime ready Configurator from Roche
Roche announces the launch of RealTime ready Configurator, the latest innovation in the online configuration of custom qPCR assays for human targets.
Wednesday, October 07, 2009
Scientific News
Surprising Mechanism Behind Antibiotic-Resistant Bacteria Uncovered
Now, scientists at TSRI have discovered that the important human pathogen Staphylococcus aureus, develops resistance to this drug by “switching on” a previously uncharacterized set of genes.
Researchers Develop qPCR Prognosis Test for NSCLC Patients
A nine-gene molecular prognostic index (MPI) for patients with early-stage non-small cell lung cancer (NSCLC) was able to provide accurate survival stratification and could potentially inform the use of adjuvant therapy in patients struggling with the disease.
Genome Wide Annotation of Primary miRNAs Reveals Novel Mechanisms
Researchers have devised a strategy for genome-wide annotation of primary miRNA transcripts, providing extensive new annotations in human and mouse, and shedding light on mechanisms of regulation of microRNA gene expression.
‘Fishing Expedition’ Nets Nearly Tenfold Increase in Number of Sequenced Virus Genomes
Newly developed computational tool finds 12,500 genomes of viruses that infect microbes.
First Gene that Causes Mitral Valve Prolapse Identified
An international research collaboration led by MGH investigators has identified the first gene in which mutations cause the common form of mitral valve prolapse, a heart valve disorder that affects almost 2.5 percent of the population.
Automation Abound at AACC in Atlanta
Discover the latest breakthroughs, trends and products from the AACC Annual Meeting & Clinical Lab Expo.
Ultrafast DNA Diagnostics
New technology developed by UC Berkeley bioengineers promises to make a workhorse lab tool cheaper, more portable and many times faster by accelerating the heating and cooling of genetic samples with the switch of a light.
The Genetic Roots of Adolescent Scoliosis
Scientists at the RIKEN Center for Integrative Medical Sciences in collaboration with Keio University in Japan have discovered a gene that is linked to susceptibility of Scoliosis.
Diagnostic Test Developed for Enterovirus D68
researchers at Washington University School of Medicine in St. Louis have developed a diagnostic test to quickly detect enterovirus D68 (EV-D68), a respiratory virus that caused unusually severe illness in children last year.
Simple Technology Makes CRISPR Gene Editing Cheaper
University of California, Berkeley, researchers have discovered a much cheaper and easier way to target a hot new gene editing tool, CRISPR-Cas9, to cut or label DNA.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!