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

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



  • Over 99 percent of cervical cancers are caused by persistent high-risk HPV infection.one
  • The cobas HPV assay helps to screen critically for identifying women at risk before developing precancerous diseases or cancer.
  • The cobas 6800/8800 systems provide complete automation by helping laboratories ensure the bandwidth required for a large volume of HPV DNA screening programs.

LAVAL, QC, January 31, 2019 / CNW / – Roche Diagnostics obtains Health Canada permission to promote cobas® HPV for cobas® 6800/8800 systems for screening cervical cancer in Canada,

Human papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA test adds to the growing menu of Canadian IVDs on cobas® 6800/8800 systems and gives laboratories the ability to test for HPV DNA simultaneously with other previously released cobas tests, including: HIV-1, HCV, HBV, CMV, DPX plus two donor analyzes cobas® MPX and cobas® WNV screening.

As shown by a prospective clinical study "AFINA"2“Comparing screening strategies using the cobas® HPV test on the cobas® 4800 system, screening with the HPV test reveals a higher disease than just the Pap test. strategies because it helps maintain screening effectiveness and protects women from potential harm from overuse. Countries are increasingly seeking to use HPV DNA detection as their primary screening tool instead of Pap testing as part of their national cervical cancer programs.3,

“As the territorial and provincial screening programs and laboratories seek to introduce HPV for primary screening, they require systems that provide the highest performance standards that Roche provides, as well as new ways to increase efficiency, which ultimately benefit everyone who receives or provides medical care. across the country "said Whitney green, President and CEO, Roche Diagnostics, a division of Hoffmann-La Roche Limited, Canada, “In addition to the powerful clinical benefits of the cobas® HPV test, Roche now meets the needs of both low and medium volume laboratories and high capacity laboratories in Canada who want to combine many proven analyzes on a single platform. ".

The fully automated cobas® 6800/8800 systems provide the fastest turnaround times, high throughput and longest transition times compared to other automated molecular platforms, giving laboratories the flexibility to adapt to changing testing requirements.

About Roche Cervical Cancer Portfolio
Roche's cervical cancer portfolio allows health workers to better monitor, manage, and diagnose women, based on the accuracy and clarity of results as part of continuous patient care. A unique combination of molecular, cellular and tissue diagnostic tests provide healthcare professionals with powerful information to make patient care decisions and minimize unnecessary treatment.
Testing cobas® HPV is clinically validated for the initial screening of HPV, ASC-US, or co-testing (HPV and Pap cytology) using cobas® 4800 or cobas® 6800/8800 systems. The cobas® HPV assays provide specific genotyping information for HPV 16 and HPV 18, the highest-risk types, and at the same time report 12 other high-risk HPV types as a combined result, all in one test and from a single patient sample. More information on cobas® HPV can be found at http://www.rochecanada.com/.
Using advanced dual biomarker technology to simultaneously detect p16 and Ki-67, CINTEC PLUS PLUS uniquely identifies transforming HPV infections, giving doctors greater confidence that they are stratifying patients for follow-up or intervention. CINtec® PLUS * Cytology is an unbiased sorting solution for managing the results of a primary screening for papillomavirus or abnormal Pap cytology and helps eliminate some of the limitations of traditional pap cytology.
Histology CINtec® is used to confirm the presence or absence of highly specific diseases of the cervix in women who have had a tissue biopsy. Histology CINtec® uses the p16 biomarker for a more accurate diagnosis to provide a clear visual confirmation of precancerous cervical lesions that can only be missed by H & E or morphological interpretation. Both CINtec® analyzes were fully automated on VENTANA BenchMark IHC / ISH instruments.

About cobas 6800/8800 systems
The cobas® 6800 and cobas® 8800 systems are fully integrated automated solutions that introduce a new standard for routine molecular testing in the areas of viral load monitoring, screening for donors, women's health, and microbiology. Based on the Nobel Prize-awarded PCR technology, the systems are designed to provide complete automation, increase throughput and speed up processing, which gives users greater flexibility to improve overall workflow efficiency. The systems provide up to 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 on systems, visit http://www.rochecanada.com

Recommendations

  1. Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189: 12-19.
  2. MH, Wright TC, Sharma A, et al. High-risk human papillomavirus testing in women with ASC-US cytology: results of the ATHENA HPV study. Am J Clin Pathol. 2011; 135 (3): 468-475.
  3. Adapted from the WHO Guidelines for Screening and Treating Precancerous Lesions for the Prevention of Cervical Cancer http://apps.who.int/iris/bitstream/10665/94830/1/9789241548694_eng.pdf

About Roche Group
Roche is a global pharmaceutical and diagnostic pioneer focused on developing science to improve people's lives. Combining the strengths of pharmaceuticals and diagnostics under one roof has made Roche a leader in personalized healthcare — a strategy designed to best match the right treatment for each patient.

Roche is the world's largest biotechnology company, with truly differentiated drugs in the field of oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in the field of in vitro diagnostics and tissue diagnostics of cancer, as well as a leader in the treatment of diabetes.

Founded in 1896, Roche continues to search for the best ways to prevent, diagnose and treat diseases and make a steady contribution to the development of society. The company also seeks to improve patient access to medical innovation by working with all stakeholders. Thirty drugs developed by Roche are included on the World Health Organization's Essential Drug List of Essential Medicines, including vital antibiotics, antimalarials and cancer drugs. Roche has been recognized as a group leader in sustainable development in the pharmaceutical, biotechnology and biomedical industries for ten years in a row on Dow Jones Sustainability Indexes (DJSI).
Roche Group, headquartered in Basel, Switzerland, works in more than 100 countries and in 2017 there were about 94,000 people worldwide. In 2017, Roche has invested 10.4 billion Swiss francs in R & D and placed sales 53.3 billion Swiss francs, Genentech, in United States, is a 100% member of the Roche Group. Roche is the majority shareholder of Chugai Pharmaceutical, JapanFor more information, please visit www.roche.com.

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SOURCE Roche Diagnostics

For more information: Roche Diagnostics, tel: (450) 686-3138

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