Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

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

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 4,800+ 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 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 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 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, 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
Roche Acquires Genia Technologies for up to $350M
Acquisition of the privately held Genia to strengthen Roche's next generation sequencing pipeline.
Monday, June 02, 2014
Roche Acquires IQuum
Acquisition will allow Roche to quickly enter the point of care segment of molecular diagnostics.
Monday, April 07, 2014
Roche, Discuva Collaborate
Companies join forces to combat life-threatening infections caused by multi-drug resistant bacteria.
Friday, February 28, 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
Change to the Roche Corporate Executive Committee
Appointment of John C. Reed as Head of Roche Pharma Research and Early Development.
Monday, January 28, 2013
Kingston Hospital Delivers Point of Care Testing Excellence
Roche cobas® b 221 blood gas analysers and Roche POC IT connectivity bring improvements for patients and staff alike.
Tuesday, July 03, 2012
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
Roche Enters Strategic Alliance with Technoclone to Expand Reagent Portfolio for Coagulation Diagnostics Line Targeted for US and Canada in 2014
Focus on reagents for thrombosis and cardiovascular diagnostics complements Roche plans to introduce comprehensive line of coagulation analyzers for hospital and reference labs
Wednesday, February 01, 2012
Roche Diagnostics Announces Dan Zabrowski as New Head of Roche Applied Science
He succeeds Paul Brown who has led Roche Applied Science since September 2011. Dan Zabrowski will report to Daniel O’Day, COO Roche Diagnostics.
Tuesday, January 31, 2012
Scientific News
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
CDC Updates Zika Recommendations
CDC has issued updated Zika recommendations and guidance for healthcare providers with a focus on sexual transmission.
Review of the Analysis of Haemoglobin A1c for Diabetes Diagnostics
This paper aims to clarify methods, units, quality requirements, reference and cutoff limits for hemoglobin A1c (HbA1c) and ratio of blood glucose/HbA1c on the basis of the results from Finnish quality control surveys by comparing them to the literature.
Colon Cancer Blocked in Mice
Case Western Reserve University Researchers block common type of colon cancer tumour in mice, laying groundwork for human clinical trial.
Drug - Gene 'One-Two' Punch Against Cancer
Researchers identify gene-drug combinations that, together, target and kill cancer cells while not targeting healthy cells.
Liquid Biopsies Treating Ovarian Cancer
Researchers have discovered a promising monitor and treat recurrence of ovarian cancer. Detecting cancer long before tumours reappear.
72% Rise in Metastatic Prostate Cancer
Over the 2003-2013 period metastatic cancer has increased by an average of 72%, this could be caused by lax screening, more aggressive disease or both.
Lab-Tested Diagnosis Needed When Treating Persistent Diarrhea
New PCR multiplex method makes lab testing more effective.
Biomarker for Multiple Sclerosis Detection Discovered
Winthrop-University Hospital researchers discover biomarker for multiple sclerosis detection.
Scientists Link Bipolar Disorder to Unexpected Brain Region
Researchers from The Scripps Research Institute have found that gene within the brain’s striatum could be linked to biopolar disorder.
SELECTBIO

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
4,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!