Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

FDA Approves New Streamlined Workflow Option for Roche's Cobas HPV Test

Published: Friday, June 28, 2013
Last Updated: Thursday, June 27, 2013
Bookmark and Share
New process allows labs to use same Pap test vial instead of transferring sample to new vial, thus simplifying workflow.

Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a new, more efficient workflow process for the cobas HPV Test, allowing sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing.

This development allows labs to load the same vial used for a ThinPrep Pap test directly onto Roche's cobas 4800 System for high-risk HPV (Human Papillomavirus) and individual HPV 16 and 18 genotype testing, which is used to help identify women at risk for cervical cancer.

"With new clinical guidelines for cervical cancer screening issued last year, the demand for HPV co-testing has the potential to increase significantly," said Alan Wright, MD, MPH, chief medical officer for Roche Diagnostics.

Wright continued, "Giving labs the option to use the same primary vial from a Pap test for HPV testing lets them eliminate a complete step in their workflow process and lower the risk of errors in sample handling, helping to ensure that patients receive accurate test results."

The new workflow option utilizes a special primary vial rack for the fully automated cobas 4800 System. The new process eliminates the need for lab technologists to pipette samples from the primary vials used for liquid-based cytology into a separate tube.

Instead, they can load the same vial onto the cobas 4800 System directly after cytology processing.

The streamlined workflow can help labs reduce costs, improve turnaround time and free staff to spend time on other critical tasks.

The cobas HPV Test, approved by the FDA in 2011, is the first HPV test to receive FDA approval for loading a Pap sample vial directly onto an automated system and for the use of primary vial samples after cytology processing on either the ThinPrep 3000 (T3000) system or the ThinPrep 2000 (T2000) system.

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 2,600+ scientific posters on ePosters
  • More Than 3,800+ 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 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 Introduces Enhanced Whole Exome Sequencing Solution
The company has announced the launch of the SeqCap EZ MedExome Target Enrichment Kit1.
Wednesday, September 23, 2015
US FDA Grants Therapy Designation for Roche’s Investigational Medicine ACE910
First factor VIIIa-mimetic bispecific antibody to be investigated for the prophylactic treatment of haemophilia A.
Tuesday, September 08, 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 Acquires GeneWEAVE to Strengthen Offerings in Microbiology Diagnostics
GeneWEAVE’s Smarticles technology enhances Roche’s role in fighting drug-resistant bacteria.
Friday, August 14, 2015
Roche's Investigational Immunotherapy Shrank Bladder Cancer Tumors in Pivotal Study
The company have announced the success of atezolizumab in shrinking tumors people with locally advanced or metastatic urothelial bladder cancer.
Tuesday, July 14, 2015
Roche Acquires Ariosa Diagnostics
Acquisition will see Roche enter the non-invasive prenatal test (NIPT) and cell-free DNA testing services markets.
Wednesday, December 03, 2014
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 to Invest in New Diagnostic Manufacturing Facility in China
The facility will address Asia Pacific’s growing demand for diagnostics.
Monday, November 10, 2014
Roche Invests For The Future In Its Basel Site
Investments of 3 billion Swiss francs in modern research infrastructure, attractive workplaces and sustainable site development.
Thursday, October 23, 2014
Roche Acquires AbVitro Technology
Roche acquires rights to technology and patent applications from AbVitro to support next-generation sequencing pipeline.
Thursday, October 09, 2014
Roche and InterMune Reach Definitive Merger Agreement
Roche to acquire InterMune for US$ 74.00 per share.
Thursday, August 28, 2014
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
Scientific News
13 Ways to Stop an Unseen Force from Disrupting Weighing
Download a free Mettler Toledo paper to discover how to halt static’s negative effects before the next weigh-in.
Flinders Ig Nobel Winner Cracks Global Anaesthetic
One of the world’s most in-demand anaesthetics can now be produced on the spot, thanks to the thermos-flask sized device that recently won Flinders University inventor Professor Colin Raston an Ig Nobel prize.
Resurrected Proteins Double Their Natural Activity
Researchers demonstrate method for reviving denatured proteins.
Genes That Protect African Children From Developing Malaria Identified
Variations in DNA at a specific location on the genome that protect African children from developing severe malaria, in some cases nearly halving a child’s chance of developing the life-threatening disease, have been identified in the largest genetic association study of malaria to date.
Messing With The Monsoon
Manmade aerosols can alter rainfall in the world’s most populous region.
Potential Target for Treatment of Autism
Grant of $2.4 million will support further research.
Scientists Decode Structure at Root of Muscular Disease
Researchers at Rice University and Baylor College of Medicine have unlocked the structural details of a protein seen as key to treating a neuromuscular disease.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
New Test Detects All Viruses
A new test detects virtually any virus that infects people and animals, according to research at Washington University School of Medicine in St. Louis, where the technology was developed.
Inroads Against Leukemia
Potential for halting disease in molecule isolated from sea sponges.
Scroll Up
Scroll Down
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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos