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
INDIANAPOLIS, June 26, 2013
INDIANAPOLIS, June 26, 2013 /PRNewswire/ --Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today 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.
"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.
About the cobas HPV Test
Clinically validated by the landmark ATHENA trial, thecobasHPV Test is the
only FDA-approved HPV assay that provides specific genotyping information for
HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12
other high-risk HPV types as a pooled result, all in one run, from one patient
sample.The test is approved to screen patients age 21 and older with
abnormal Pap test results and to co-test with Pap in women ages 30 to 65 to
assess the presence or absence of high-risk HPV genotypes.
The test is performed on the cobas 4800 System, which offers true walk-away
automation of nucleic acid purification, PCR (polymerase chain reaction)
set-up and real-time PCR amplification and detection to help laboratories
achieve maximum efficiency. The system also runs the cobas CT/NG Test
(chlamydia/gonorrhea), the cobas BRAF V600 Mutation Test and the cobas EGFR
About Human Papillomavirus and Cervical Cancer
Persistent infection with Human Papillomavirus is the principal cause of
cervical cancer in women, with HPV implicated in greater than 99 percent of
cervical cancers worldwide. According to the National Cancer Institute, there
are 12,200 new cases of cervical cancer in the United States annually and
4,210 deaths due to the disease. The World Health Organization estimates there
are 470,000 new cases of cervical cancer annually.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche
is the world's largest biotech company, with truly differentiated medicines in
oncology, infectious diseases, inflammation, metabolism and neuroscience.
Roche is also the world leader in in vitro diagnostics and tissue-based cancer
diagnostics, and a frontrunner in diabetes management. Roche's personalized
healthcare strategy aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of
patients. In 2012 Roche had over 82,000 employees worldwide and invested over
8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss
francs. Genentech, in the United States, is a wholly owned member of the Roche
Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For
more information, please visit www.roche.com or www.roche-diagnostics.us.
COBAS is a trademark of Roche. ThinPrep is a trademark of Hologic. All
trademarks mentioned in this release are protected by law.
For further information, please contact:
Director, Corporate Communications
Roche Diagnostics Corporation
Indianapolis, Indiana USA
SOURCE Roche Diagnostics
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