Corporate Banner
Satellite Banner
Genomics
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

Join For Free

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 3,300+ scientific posters on ePosters
  • More than 4,900+ 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’s MabThera SC Receives Approval in Europe
Company has announced that the EC has approved the SC formulation of MabThera® for people with previously untreated chronic lymphocytic leukaemia (CLL).
Friday, June 03, 2016
FDA Grants Roche’s Cancer Immunotherapy Tecentriq Accelerated Approval
Company has announced that the U.S. FDA has granted accelerated approval to Tecentriq® for the treatment of people with a specific type of advanced bladder cancer.
Friday, May 20, 2016
Tensha Therapeutics to be Acquired by Roche
Tensha Therapeutics, a privately-held company based in Cambridge, MA, has announced it will be acquired by Roche.
Tuesday, January 12, 2016
Roche Introduces Enhanced Whole Exome Sequencing Solution
The company has announced the launch of the SeqCap EZ MedExome Target Enrichment Kit1.
Wednesday, September 23, 2015
Roche to Acquire Kapa Biosystems
Acquisition to strengthen next-generation sequencing product offerings.
Friday, August 21, 2015
Roche's Investigational Immunotherapy Atezolizumab Shrank Tumours in People with Lung Cancer
Roche will discuss results with the U.S. FDA as part of atezolizumab’s Breakthrough Therapy Designation in lung cancer.
Wednesday, August 19, 2015
Pivotal Phase II Study of Venetoclax Met Primary Endpoint
Venetoclax is a small molecule inhibitor of the BCL-2 protein, which potentially represents a new way of treating blood cancers.
Friday, August 14, 2015
Roche, Garvan Institute Epigenomic Partnership
Roche and the Garvan Institute of Medical Research today announce a collaboration to develop new technologies for targeted epigenomic analysis using DNA sequencing.
Wednesday, August 20, 2014
FDA Approves Roche’s Advanced Cervical Cancer Chemotherapy
Avastin is the first biologic medicine approved in combination with chemotherapy to help women with this type of cancer live longer than with chemotherapy alone.
Monday, August 18, 2014
Roche to Acquire Seragon Pharmaceuticals
Acquisition of Phase I program offers a potential new approach for hormone receptor-positive breast cancer.
Wednesday, July 02, 2014
Roche Invests in Stratos Genomics
Investment by Roche will advance Stratos Genomics chemistry for nanopore sequencing.
Friday, June 27, 2014
Roche Recieves FDA Approval for Cervical Cancer Screening HPV Test
Expanded indication makes cobas HPV Test the only test approved in U.S. that can be used instead of Pap in first-line primary screening in women 25 and older.
Friday, April 25, 2014
Roche, Oryzon Announce Epigenetics Collaboration
Collaboration spans research, development and commercialization of LSD1 inhibitors for oncology, haematology and non-malignant conditions.
Monday, April 07, 2014
Roche and Molecular Partners Enter into Alliance
Partnership will combine novel biologics with Roche drug-conjugate technology to develop new cancer treatments.
Wednesday, December 04, 2013
FDA Approves New Streamlined Workflow Option for Roche's Cobas HPV Test
New process allows labs to use same Pap test vial instead of transferring sample to new vial, thus simplifying workflow.
Friday, June 28, 2013
Scientific News
Breast Cancer Cells Found To Switch Molecular Characteristics
Spontaneous interconversion between HER2-positive and HER2-negative states could contribute to progression, treatment resistance in breast cancer.
Some Breast Cancer Patients With Low Genetic Risk Could Skip Chemotherapy
Genetic test can help predict survival and guide treatment options.
Lose Weight, Escape the Eight: Weight-Based Cancer Risk
IARC has identified eight additional cancer sites linked to overweight and obesity.
Coffee Consumption Linked to Genes
Researchers have identified a gene that influences coffee consumption. The gene is thought to relate to caffeine breakdown.
Emerging Model of Cancer
Cancer acts cooperatively, making individual decisions but acting in unison; this insight is being used to create a computer model of cancer.
Biological Barcodes Using CRISPR
Using genome editing tools, researchers are getting closer to understand differentiation of various cell types during development.
Controlling DNA Repair
Scientists discover that DNA repair outcomes following CRISPR-Cas9 cleaving are non-random and can be harnessed to produce desired effects.
Demonstrating LNP Delivery of CRISPR Components
Intellia has presented data demonstrating in vivo gene editing ising liquid nanoparticles (LNPs) to deliver CRISPR/Cas9.
Gene Therapy Via Ultrasound
Research into a gene therapy approach called sonoporation could help combat heart disease and cancer.
Creating Embryos with 'Heteroplasmy'
New discovery in genetic research could lead to treatments for mitochondrial diseases.
Skyscraper Banner

SELECTBIO Market Reports
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!