- More than 99% of cervical cancers are caused by a persistent high-risk HPV infection1
- The cobas HPV Assay helps provide critical screening in identifying women at risk before pre-cancer or cancer develops
- The cobas 6800/8800 systems offer complete automation, helping laboratories meet the demand that high-volume DNA screening programs demand
LAVAL, QC, January 31, 2019 / CNW / – Roche Diagnostics receives authorization from Health Canada to market cobas® HPV on cobas® 6800/8800 systems for cervical cancer screening in Canada.
Human papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA assay contributes to the growing Canadian-IVD menu on cobas® 6800/8800 systems and gives laboratories the ability to perform the HPV DNA test simultaneously with other previously released cobas tests including: HIV-1, HCV, HBV , CMV, DPX plus two cobas® MPX and cobas® WNV donor screening assays.
As demonstrated by the prospective clinical study "ATHENA2"Comparing screening strategies using the cobas® HPV test in the cobas® 4800 system, HPV screening detects more high-grade disease than a Pap smear. Identifying women at risk, before the onset of cancer or cancer is an important prevention Most countries are increasingly looking to adopt HPV DNA screening as their primary screening tool instead of the Pap smear as part of their national cervical cancer programs.3.
"As regional and provincial programs and laboratories seek the introduction of HPV for primary screening, they require systems that deliver the highest standards of performance that Roche offers, as well as new ways to increase efficiency, which benefit everyone who receives or health care throughout the country. " Whitney Green, President and General Manager, Roche Diagnostics, division of Hoffmann-La Roche Limited, Canada. "In addition to the powerful clinical benefits of the cobas® HPV test, Roche now addresses the needs of low- to medium-volume laboratories and high-productivity laboratories in Canada that want to consolidate a multitude of validated tests on a single platform"
The fully automated cobas® 6800/8800 systems provide the fastest turnaround time, increased productivity and longer clearance 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 portfolio enables health professionals to better select, manage and diagnose women based on trust and clarity of results in a continuum of patient care. The unique combination of molecular, cellular, and tissue-based diagnostic tests provide healthcare professionals with powerful information to make patient care decisions and minimize unnecessary treatment.
The cobas® HPV test is clinically validated for primary HPV screening, ASC-US screening or co-testing (HPV cytology and Pap smears) using cobas® 4800 or cobas® 6800/8800 systems. The cobas® HPV tests provide specific genotyping information for the HPV 16 and HPV 18 higher risk types and simultaneously report the 12 other high risk HPV types as a combined result, all in one test and one patient sample . More information on cobas® HPV is available at http://www.rochecanada.com/.
Using advanced dual biomarker technology to simultaneously detect p16 and Ki-67, CINtec® PLUS Cytology * definitively identifies transformative HPV infections, giving clinicians greater confidence to stratify patients for follow-up or intervention. CINtec® PLUS Cytology * is an objective screening solution for the management of positive or abnormal Pap smear screening results for HPV and helps address some of the limitations of traditional Pap cytology.
CINtec® histology is used to confirm the presence or absence of high-grade cervical disease in women who had a tissue biopsy. CINtec® Histology uses the p16 biomarker for a more conclusive diagnosis to provide distinct visual confirmation of precancerous cervical lesions that may go unnoticed by H & E or only by morphological interpretation. Both CINtec® assays were fully automated on the VENTANA BenchMark IHC / ISH instruments.
About cobas systems 6800/8800
The cobas® 6800 and cobas® 8800 systems are fully integrated and 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 Nobel Prize-winning PCR technology, systems are designed to provide total automation, higher throughput and faster response time, giving users greater flexibility to increase 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
- Walboomers JM, Jacobs MV, Manos MM, et al. The human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189: 12-19.
- MH, Wright TC, Sharma A. et al. High-risk human papillomavirus test in women with ASC-US cytology: results from the ATHENA HPV study. Am J Clin Pathol. 2011; 135 (3): 468-475.
- Adapted from "WHO guidelines for screening and treatment of precancerous lesions for prevention of cervical cancer" http://apps.who.int/iris/bitstream/10665/94830/1/9789241548694_eng.pdf
About Roche Group
Roche is a global pioneer in pharmaceuticals and diagnostics, focusing on advancing science to improve people's lives. Combined pharmaceutical and diagnostic strengths under one roof have made Roche the leader in personalized healthcare – a strategy that aims to tailor the right treatment to each patient in the best possible way.
Roche is the world's largest biotechnology company with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in-vitro diagnostics and diagnostics of tissue-based cancer as well as a leader in diabetes management.
Founded in 1896, Roche continues to seek better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patients' access to medical innovations by working with all relevant stakeholders. Thirty drugs developed by Roche are included in the World Health Organization's Essential Medicines Lists, including life-saving antibiotics, antimalarials and cancer drugs. Roche was recognized as the group leader in sustainability in the pharmaceutical, biotechnology and biological sciences sector for ten consecutive years by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, established in Basel, Switzerland, is present in more than 100 countries and in 2017 employed around 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion research and development and sales of CHF 53.3 billion. 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, visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
SOURCE Roche Diagnostics
For more information: Roche Diagnostics, Tel: (450) 686-3138