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

Roche Recieves FDA Approval for Cervical Cancer Screening HPV Test

Published: Friday, April 25, 2014
Last Updated: Friday, April 25, 2014
Bookmark and Share
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.

Roche announce that the U.S. Food and Drug Administration (FDA) approved the cobas HPV (Human Papillomavirus) Test for use as a first-line primary screening test for cervical cancer in women 25 and older. The approval follows the March 12 unanimous recommendation from the Microbiology Devices Panel of the FDA’s Medical Devices Advisory Committee, making the cobas HPV Test the first and only HPV test in the United States approved for first-line primary screening.

“We are very pleased that the FDA has approved this test for first-line use in cervical cancer screening. It is a recognition for the value the cobas HPV Test provides to physicians and women to make more informed decisions that can ultimately prevent cervical cancer development,” said Roland Diggelmann, COO Division Roche Diagnostics. “This is an outstanding example of how innovation in diagnostics is shifting the disease management paradigm to improve patient care and people’s health. We are committed to working with the medical community and professional organizations to put the necessary clinical practice guidelines in place to encourage providers to incorporate this new screening strategy alternative in their patient protocols.”

Prior to the approval of this additional claim, HPV tests had been used as a follow-up test for Pap (Papanicolaou) results and as an adjunct to Pap in women 30 years and older.

“Today’s action by the FDA has given women a better alternative method to reassure themselves they do not have this deadly yet preventable disease,” said Mark H. Stoler, MD, Professor (Emeritus) of Pathology and Clinical Gynecology at the University of Virginia Health System. “Using the cobas HPV Test as a primary screen means that women will have the opportunity to receive a better and more accurate standard of care. Clinically validated HPV screening detects the virus that causes cervical cancer and does a better job identifying women at risk than Pap testing alone. But most importantly, women found to be HPV negative are provided a greater sense of security that they are safe from the disease.”

The cobas HPV Test provides both pooled high-risk HPV DNA results and individual detection of HPV 16 and HPV 18, the two types responsible for about 70 percent of cervical cancer. The FDA’s decision to approve the expanded use for the cobas HPV Test was based on results from the landmark ATHENA trial, which enrolled more than 47,000 women. The study demonstrated that one in four women who are HPV 16 positive will have cervical disease within three years and 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.

In addition, results from the ATHENA trial included a comparison of a cobas HPV Test screening strategy to alternative strategies using Pap cytology and HPV testing. The comparison showed that a strategy leveraging the ability of the cobas HPV Test to identify women testing positive for HPV 16 or 18, and using cervical cytology (Pap) as a triage, follow-up test, would allow clinicians to detect more disease without referring a significant number of women to unnecessary follow-up.


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'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
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, Oryzon Announce Epigenetics Collaboration
Collaboration spans research, development and commercialization of LSD1 inhibitors for oncology, haematology and non-malignant conditions.
Monday, April 07, 2014
FDA Recommends Roche's HPV Test as Primary Screening Tool
Test will assess risk of cervical cancer of women 25 years and older.
Thursday, March 13, 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
Roche and Isis Pharmaceuticals Form Alliance for Huntington's Disease
This alliance combines Isis' antisense expertise with Roche's scientific expertise in developing neurodegenerative therapeutics.
Wednesday, April 10, 2013
Roche 454 Sequencing Systems Successfully Resolve Genetic Mutations in Blood Cancer Cases
International study presented at ASH Meeting demonstrates the potential of 454 Sequencing Systems to comprehensively characterize an individual’s blood cancer type to guide personalized therapy decisions.
Thursday, December 13, 2012
Is Lunar Dust Harmful to Humans?
Exposure to lunar dust during the Apollo missions resulted in reports of ocular, respiratory and dermal irritation, suggesting that lunar dust is a potential risk to human health.
Sunday, April 17, 2011
Roche’s Assay for 2009 H1N1 Influenza Virus is Regularly Updated with the Latest Virus Sequences
The assay has been developed to provide a rapid means of identification of infected patients.
Thursday, December 03, 2009
Roche’s xCELLigence System for Determination of Optimal Time Points for Gene and Protein Expression Analysis
The xCELLigence RTCA System from Roche Applied Science allows for label-free, continuous monitoring of cell phenotypic changes using electrical impedance as readout. The interaction of cells with the electronic biosensors leads to the generation of a cell-electrode impedance response which indicates the status of the cells in terms of cell number, cell viability, cell morphology and cell attachment quality. Real-time, continuous measurement ensures the documentation of cell phenotypes in the fo
Friday, August 14, 2009
Scientific News
Microscopic Fish are 3D-Printed to do More Than Swim
Researchers demonstrate a novel method to build microscopic robots with complex shapes and functionalities.
Inciting an Immune Attack on Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
Reprogramming Cancer Cells
Researchers on Mayo Clinic’s Florida campus have discovered a way to potentially reprogram cancer cells back to normalcy.
New Strategy for Combating Adenoviruses
Using an animal model they developed, Saint Louis University and Utah State university researchers have identified a strategy that could keep a common group of viruses called adenoviruses from replicating and causing sickness in humans.
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.
Fat in the Family?
Study could lead to therapeutics that boost metabolism.
Imaging Software Could Speed Up Breast Cancer Diagnosis
Researchers use high speed optical microscopy of intact breast tissue specimens to analyze breast tissue.
A Metabolic Master Switch Underlying Human Obesity
Researchers find pathway that controls metabolism by prompting fat cells to store or burn fat.
Synthetic DNA Vaccine Against MERS Shows Promise
A novel synthetic DNA vaccine can, for the first time, induce protective immunity against the Middle East Respiratory Syndrome (MERS) coronavirus in animal species.
How Small RNA Helps Form Memories
In a new study, a team of scientists at Scripps Florida has found that a type of genetic material called "microRNA" (miRNA) plays surprisingly different roles in the formation of memory in animal models.
SELECTBIO

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!