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Home / canada / January is the month of awareness of cervical cancer. Roche is committed to preventing cervical cancer and is proud to announce that the new Roche cobas® HPV test for the use of cobas® 6800/8800 Systems has now been approved by Health Canada

January is the month of awareness of cervical cancer. Roche is committed to preventing cervical cancer and is proud to announce that the new Roche cobas® HPV test for the use of cobas® 6800/8800 Systems has now been approved by Health Canada



  • More than 99 per cent of cervical cancer are caused by a persistent high-risk HPV infection1
  • cobas HPV analysis helps to provide critical screening for identifying women at risk before developing pre-cancer or cancer
  • cobas 6800/8800 The systems provide full automation, helping the laboratories to meet the throughput,

LAVAL, QC, January 31, 2019 / CNW / – Roche Diagnostics receives authorization for health Canada for sale of cobas® HPV on cobas® 6800/8800 Cervical Screening Systems in Cervical Cancer Canada.

Human papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA vaccine is added to the increased Canadian-IVD menu of cobas® 6800/8800 Systems and gives laboratories the ability to test HPV DNA testing concurrently with other previously released cobalt analyzes, including: HIV-1, HCV, HBV , CMV, DPX plus two donor screening tests cobas® MPX and cobas® WNV.

As shown in the prospective clinical study "Atena"2"comparing screening strategies using the cobas® HPV test of the cobas® 4800 system, HPV test screening reveals a higher degree of disease than just one PAP test. Identifying risky women before developing cancer or cancer is an important prevention as it helps to maintain screening efficiency and help protect women from potential damage from over-processing. Countries are increasingly trying to adopt HPV detection as the primary screening tool instead of the pap test as part of their national programs for cancer of cervix3.

"Given that territorial and provincial screening programs and laboratories are aimed at introducing HPV for primary screening, they require systems that provide Roche's highest performance standards, as well as new ways to increase efficiency, which ultimately line benefits everyone who receives or provides health care across the country, "he said Whitney Green, President and CEO, Roche Diagnostics, a division of Hoffmann-La Roche Limited, Canada. "In addition to the powerful clinical benefits of cobas® HPV testing, Roche now takes care of the needs of low to medium volume laboratories and high capacity laboratories in Canada that want to consolidate a multitude of validated analyzes on a single platform."

Fully automated cobas® 6800/8800 systems provide the fastest turning time, highest productivity, and the longest walking time compared to other automated molecular platforms, giving laboratories the flexibility to adapt to changing test requirements.

About Roche's cervical cancer portfolio
Roche's cervical cancer cancer portfolio allows health professionals to better demonstrate, manage and diagnose women, based on the confidence and clarity of results in the continuity of patient care. The only combination of molecular, cellular, and tissue diagnostic tests gives health professionals powerful information to make patient care decisions and minimize unnecessary healing.
cobas® HPV testing is clinically validated for HPV primary screening, ASC-US triage, or catastrophy (HPV and Pap Cytology) using cobas® 4800 or cobas® 6800/8800 Systems. The HPV cobas® analysis provides specific genotype information for HPV 16 and HPV 18, the highest risk types, while simultaneously reporting 12 other high-risk HPV types as a result of association, all in one test and one sample patient. More information on cobas® HPV is available at http://www.rochecanada.com/.
Using advanced, dual biomarker technology for the simultaneous detection of p16 and Ki-67, CINtec® PLUS Cytology * definitely identifies transforming HPV infections, providing more confidence to doctors to stratify patients for monitoring or intervention. CINtec® PLUS Cytology * is an objective triage solution for the management of HPV-positive or abnormal results from the cytology of PAP cytology and helps in addressing some of the limitations of traditional PAP cytology.
CINtec® Histology is used to confirm the presence or absence of a high degree of cervical disease in women who have had a tissue biopsy. CINtec® Histology uses the p16 biomarker for a more precise diagnosis to provide specific visual confirmation of pre-cancerous cervical lesions that can be missed only with H & E or only with morphological interpretation. Both CINtec® analyzes are fully automated to VENTANA BenchMark IHC / ISH instruments.

For cobas 6800/8800 systems
The cobas® 6800 and cobas® 8800 system are fully integrated, automated solutions that introduce a new standard for routine molecular testing in the areas of viral load monitoring, donor screening, women's health and microbiology. Based on the Nobel Prize PCR technology, systems are designed to deliver full automation, increased productivity and faster rotation time, enabling users greater flexibility to increase overall performance of the workflow. The systems provide 96 results in less than 3.5 hours and a total of 384 results for the cobas 6800 system and 960 results for the cobas 8800 System in an eight-hour shift.
For more information about the systems, visit http://www.rochecanada.com

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  1. Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is an indispensable cause of invasive cervical cancer in the world. J Pathol. 1999; 189: 12-19.
  2. MH, Wright TC, Sharma A, et al. High-risk human papillomavir test in women with ASC-US cytology: results from the HPV ATHENA study. Am J Clin Pathol. 2011; 135 (3): 468-475.
  3. Adapted from the "WHO guidelines for the screening and treatment of precancerous lesions for the prevention of cervical cancer" http://apps.who.int/iris/bitstream/10665/94830/1/9789241548694_mk.pdf

About the Roche Group
Roche is a global pioneer in pharmacy and diagnostics focused on advancing science to improve people's lives. The combined strength of drugs and diagnosis under one roof made the leader in personalized health care – a strategy that aims to adapt the right treatment to each patient in the best possible way.

Roche is the world's largest biotechnology company, with truly differentiated drugs in oncology, immunology, infectious diseases, ophthalmology and central nervous system diseases. Roche is also a global leader in diagnostics for tissue-based diagnosis and diagnosis, and a leader in diabetes management.

Founded in 1896, Roche continues to seek better ways of preventing, diagnosing and treating diseases and sustaining a contribution to society. The company also aims to improve patient access to medical innovation through work with all relevant stakeholders. Thirty medicines developed by Roche are included in the models of essential drugs of the World Health Organization, among which save antibiotics, antimalarials and cancer drugs. Roche has been recognized as the leader of the sustainability group within the Pharmaceutical, Biotechnological and Industrial Environmental Policy for ten consecutive years by the Dow Jones Sustainability Index (DJSI).
Rosh Group headquartered in Basel, Switzerland, has been active in more than 100 countries and in 2017 employ approximately 94,000 people worldwide. In 2017, Roche invested 10.4 billion Swiss francs in R & D and published sales of CHF 53.3 bln. Genentech, inside United States, is wholly owned by the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, visit www.roche.com.

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