- More than 99 percent of cervical cancer is caused by permanent high-risk HPV infection1
- cobas HPV test helps to provide critical testing in identifying women at risk, before cancer or cancer develops
- cobas 6800/8800 Sistems delivers complete automation, helping the laboratories to meet the wide bandwidth.
LAVAL, KC, January 31, 2019 / CNV / – Roche Diagnostics receives Health Canada certification for the sale of cobas® HPV on cobas® 6800/8800 Cervical Screening Systems 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 added to the growing Canadian-IVD menu on cobas® 6800/8800 systems and gives laboratories the ability to test HPV DNA at the same time as other pre-release sausages, including: HIV-1, HCV, HBV, CMV, DPX plus two tests donor screening cobas® MPKS and cobas® VNV.
As the prospective clinical study "ATHENA" shows.2"Comparing screening strategies using the cobas® HPV test on the cobas® 4800 system, HPV test screening reveals a higher level of Pap smear. Identification of women at risk before cancer develops or cancer is an important prevention The Earth is increasingly seeking adopts the detection of HPV DNA as the primary screening tool in place of the Pap test as part of their national cervical cancer programs.3.
"Because territorial and provincial screening programs and laboratories look at the introduction of HPV for primary screening, they require systems that deliver the highest performance standards delivered by Roche, as well as new ways to increase efficacy, which ultimately benefits everyone who receive or provide healthcare protection across the country, "he said Vhitnei Green, President and CEO, Roche Diagnostics, Hoffmann-La Roche Limited, Canada. "In addition to the strong clinical benefits of the cobas® HPV test, Roche now meets the needs of both laboratories and high-flow laboratory in Canada that want to consolidate a variety of validated tests on one platform."
The fully automated cobas® 6800/8800 systems provide the fastest turning time, maximum bandwidth, and the longest time compared to other automated molecular platforms, giving laboratories the flexibility to adapt to changing test requirements.
About Cervical Cancer Portfolio
The Roche Cervical Cancer Portfolio portfolio allows health professionals to better examine, manage and diagnose women, based on the reliability and clarity of results through the continuity of patient care. A unique combination of molecular, cellular, and tissue diagnostic tests provides healthcare professionals with powerful information for decision-making about patient care and minimizing unnecessary treatment.
Cobas® HPV testing has been clinically validated for HPV primary screening, ASC-US triage, or co-testing (HPV and Papacitology) using cobas® 4800 or cobas® 6800/8800 Sistems. Cobas® HPV tests provide specific information on genotyping for HPV 16 and HPV 18, the highest risk types, while at the same time pointing out 12 other high-risk HPV types as a combined result, all in one test and one patient sample. More information about cobas® HPV can be found at http: //vv.rochecanada.com/.
Using advanced biomarker technology for simultaneous detection of p16 and Ki-67, CINtec® PLUS Cytology * definitely identifies the transformation of HPV infection, providing greater safety for clinicians to stratify patients for monitoring or intervention. CINtec® PLUS Cytology * is an objective solution for treating HPV-positive or abnormal results of primary screening on Pap-cytology and helping to address some of the limitations of traditional Pap citology.
CINtec® Histologists are used to confirm the presence or absence of high-grade cervical disease in women who have had tissue biopsy. CINtec® Histologists use biomarker p16 for a definitive diagnosis to provide a recognizable visual confirmation of pre-cancerous cervical lesions that can be missed only by H & E or by morphological interpretation. Both CINtec® tests are fully automated on VENTANA BenchMark IHC / ISH instruments.
About kobas 6800/8800 Systems
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, donor screening, women's health and microbiology. Based on Nobel Prize-winning PCR technology, systems are designed to provide complete automation, increased bandwidth and faster operation time, providing users with greater flexibility to increase overall workflow efficiency. The systems deliver up to 96 results in less than 3.5 hours and a total of 384 results for the sausage 6800 and 960 results for the kobas 8800 system in an eight-hour shift.
For more information about systems, visit http: //vv.rochecanada.com
- Valboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer in the world. J Pathol. 1999; 189: 12-19.
- MH, Vright TC, Sharma A, et al. High-risk papilloma virus examination in women with ASC-US cytology: results of the ATHENA HPV study. Am J Clin Pathol. 2011; 135 (3): 468-475.
- Adapted from the "WHO Guidelines for Screening and Treatment of Precancerous Lesions for the Prevention of Cervical Cancer" http: //apps.vho.int/iris/bitstream/10665/94830/1/9789241548694_eng.pdf
About Roche Group
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceutical products and diagnosis under one roof have made Roche 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 really different drugs in oncology, immunology, infectious diseases, ophthalmology and central nervous system diseases. Roche is the world leader in diagnostics in vitro diagnosis and tissue diagnostics of cancer, and leading in the management of diabetes.
Founded in 1896, Roche continues to seek better ways of preventing, diagnosing and treating diseases and a sustainable contribution to society. The company also aims to improve patients' access to medical innovation by working with all relevant actors. Thirty medicines developed by Roche are included in the list of World Health Organization Essentials, including antibiotics, antimalarials and cancer drugs. Roche has been recognized as a sustainability leader within the pharmaceutical, biotechnology and biotechnology industry for ten years in a row by the Dov Jones Sustainability Index (DJSI).
Group Roche, headquartered in Belgrade Basel, Switzerland, has been active in more than 100 countries and in 2017 it has employed around 94,000 people around the world. In 2017, Roche invested 10.4 billion Swiss francs in research and development and published sales 53.3 billion Swiss francs. Genentech, u United States, is wholly owned by the Roche Group. Roche is the majority owner of Chugai Pharmaceutical, Japan. For more information, visit vvv.roche.com.
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SOURCE Roche Diagnostics
For further information: Roche Diagnostics, Tel: (450) 686-3138