- More than 99 percent of cervical cancers are caused by persistent HPV infection at high risk1
- The HPV assay assists in providing a critical detection in the identification of at-risk women, before pre-cancerous cancer or cancer is developed
- Cobas 6800/8800 Systems offer a complete automation, helping laboratories to achieve the performance of large-scale DNA detection programs for HPV detection programs
LAVAL, QC, January 31, 2019 / CNW / – Roche Diagnostics receives the authorization from Health Canada to market cobas® HPV to cobas® 6800/8800 Systems for the detection of 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 is adapted to the growing Canadian menu-IVD in cobas® 6800/8800 systems and gives laboratories the possibility of performing HPV DNA tests simultaneously with other tests of Cobas previously published, including: HIV-1, HCV, HBV, CMV, DPX plus two screening trials of cobas® MPX donors, and Cobas® WNV.
As demonstrated by the prospective clinical study "ATHENA2"Comparing screening strategies with the HPV Cobas® test on the Cobas® 4800 system, detection with the HPV test detects more high-grade disease than the Pap smear test. The identification of women at risk before the Pre-cancer or cancer is an important prevention strategy since it helps to maintain the efficiency of detection and helps protect women from the potential harm of excessive treatment. Countries increasingly seek to adopt DNA detection HPV as a primary detection tool instead of the Pap test, as part of its national uterine cancer programs3.
"As provincial and provincial projection programs and laboratories seek to introduce HPV for primary screening, they require systems that offer high performance standards that Roche offers, as well as new ways of increasing the # 39 ; efficiency, which ultimately benefits all those who receive or provide healthcare throughout the country. "said 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 serves the needs of both low-to-mid laboratories and high-performance laboratories in Canada that want to consolidate a multitude of validated trials in one only platform. "
Fully automated Cobas® 6800/8800 systems provide faster turnaround time, higher performance and longer-distance time compared to other automated molecular platforms, offering labs the flexibility to adapt to Changing demands of evidence.
About the Roche Cervical Cancer portfolio
The Roche Cervical Cancer portfolio allows health professionals to improve screening, management and diagnosis of women, based on trust and clarity of results in a continuous patient care. The unique combination of molecular, cellular and tissue-based diagnostic tests provides health professionals with powerful information to make patient-care decisions and minimize unnecessary treatment.
Cobas® HPV tests are clinically validated for primary HPV detection, ASC-US trials or coprotesis (HP and PAP cytology) using Cobas® 4800 or Cobas® 6800/8800 systems. Cobas® HPV trials provide specific genotypic information for HPV 16 and HPV 18, the highest risk types, while simultaneously reporting the other 12 types of high-risk HPV as a clustered result, all in one test and a patient sample. For more information about cobas® HPV, visit http://www.rochecanada.com/.
The use of advanced dual biomarker technology to simultaneously detect p16 and Ki-67, CINtec® PLUS Cytology * definitively identifies the transformation of HPV infections, providing greater safety for clinicians to stratify patients for follow-up or intervention . CINtec® PLUS Cytology * is an objective triage solution to manage the results of primary detection of positive or abnormal Pap smear cytology, and helps to address some of the limitations of traditional Pap cytology.
The histology CINtec® is used to confirm the presence or absence of high cervical disease in women who have had a tissue biopsy. Histology CINtec® uses biomarker p16 for a more conclusive diagnosis to provide a distinctive visual confirmation of precancerous cervical lesions that can be lost only by H & E or morphological interpretation. The two CINtec® tests have been fully automated in the VHTAN BenchMark IHC / ISH instruments.
About Cobas 6800/8800 systems
Cobas® 6800 and Cobas® 8800 systems are fully integrated, automated solutions that introduce a new standard for routine molecular tests in the areas of viral load monitoring, donor detection, women's health and microbiology. Based on Nobel-winning PCR technology, systems are designed to offer full automation, higher performance and faster response time, offering users greater flexibility to increase the overall efficiency of the workflow. 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 about the Systems, visit http://www.rochecanada.com
- Walboomers JM, Jacobs MV, Mans MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer around the world. J Pathol. 1999; 189: 12-19.
- MH, Wright TC, Sharma A, et al. High risk human papillomarxism testing in women with ASC-US cytology: results of 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 the prevention of cervical cancer" http://apps.who.int/iris/bitstream/10665/94830/1/9789241548694. pdf
About the Roche Group
Roche is a world pioneer in pharmaceuticals and diagnosis focused on the advancement of science to improve the lives of people. Combined strengths of pharmaceutical and diagnostic products under one roof have made Roche a leader in personalized attention, a strategy that aims to adapt to the best possible treatment for each patient in the best possible way.
Roche is the largest biotech company in the world, with medications that are really differentiated in oncology, immunology, infectious diseases, ophthalmology and central nervous system diseases. Roche is also a world leader in the diagnosis of vitro and diagnosis of cancer based on tissues, and a leader in diabetes management.
Founded in 1896, Roche continues to seek better ways to prevent, diagnose and treat illnesses and contribute sustainably to society. The company also aims to improve patient access to medical innovations by working with all relevant interest groups. Thirty medications developed by Roche include in the lists of essential medicines of the World Health Organization, which include life-saving, anti-malarial antibiotics and cancer medications. Roche has been recognized as the leader of the group in sustainability within the Pharmaceutical Industry, Biotechnology and Life Sciences ten years in a row by the Dow Jones Sustainability Indices (DJSI).
Roche Group, based at Basel, Switzerland, it actively participates in more than 100 countries and, in 2017, has about 94,000 people around the world. In 2017, Roche invested CHF 10.4 billion in R & D and published sales of CHF 53.3 billion. Genentech, a the United States, is a member of the Roche Group's total ownership. Roche is the majority shareholder of Chugai Pharmaceutical, Japan. For more information, visit www.roche.com.
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