Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec®PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtecPLUS Cytology to triage positive results from the cobas ® HPV Test run on the fully integrated, automated and high-throughput cobas® 6800/8800 Systems. High-risk HPV is the principal cause of cervical cancer, which is one of the most common cancers in women globally. The World Health Organization has set goals for countries to take action to eliminate cervical cancer by 2030.“With our portfolio of cervical cancer tests and automated testing platforms, we are committed to providing clinicians and laboratories with the best tools possible to protect women’s health,” said Thomas Schinecker, CEO Roche Diagnostics. “This expanded indication for CINtecPLUS Cytology gives laboratories the flexibility to triage cobas HPV test results on their choice of cobas ® Systems and deliver accuracy needed to reliably detect HPV infections that are starting to cause cellular changes that could lead to cancer. The biomarker information helps to clarify a woman&r...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news

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Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec®PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtecPLUS Cytology to triage positive results from the cobas ® HPV Test run on the fully integrated, automated and high-thr...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news
             Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval for the cobas ® HPV test for use on the fully automated, high-throughput cobas® 6800/8800 Systems. The cobas® HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into pre cancerous lesions and, if left untreated, these lesions can progress to cervical cancer.“The approval ...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news
Prevention is often called the best medicine — but research has shown that millions of Americans are not getting the preventive care they should to live long, healthy lives. Obstacles like inadequate access to care and financial barriers can keep people away from the doctor, but anxiety and feeling like care is unnecessary are also common deterrents. “There are a lot of things that every person could do to stay healthy, and this could help people to feel better, improve their quality of life and help them to live longer,” says Dr. Alex Krist, a professor of family medicine at Virginia Commonwealth Univer...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Longevity public health Source Type: news
Gulcin Tezcan1, Ekaterina V. Martynova1, Zarema E. Gilazieva1, Alan McIntyre2, Albert A. Rizvanov1 and Svetlana F. Khaiboullina1,3* 1Institute of Fundamental Medicine and Biology, Kazan Federal University, Kazan, Russia 2Centre for Cancer Sciences, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, United Kingdom 3Department of Microbiology and Immunology, University of Nevada, Reno, Reno, NV, United States Inflammation has a crucial role in protection against various pathogens. The inflammasome is an intracellular multiprotein signaling complex that is linked to pathogen sensing and...
Source: Frontiers in Pharmacology - Category: Drugs & Pharmacology Source Type: research
We report a case of misdiagnosed endometrial cancer by D&C, but with a positive cytopathological finding. Following that, a meta-analysis including 4,179 patients of endometrial diseases with cyto-histopathological results was performed to assess the value of the endometrial cytological method in endometrial cancer diagnosis. The pooled sensitivity and specificity of the cytological method in detecting endometrial atypical hyperplasia or cancer was 0.91[95% confidence interval (CI) 0.74–0.97] and 0.96 (95% CI 0.90–0.99), respectively. The pooled positive likelihood ratio and negative likelihood ratio was 25.4 (...
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
The objective of this report was to summarize current knowledge of CC, squamous intraepithelial lesions, and human papillomavirus (HPV) infection in non-HIV immunocompromised women to determine best practices for CC surveillance in this population and provide recommendations for screening. We evaluated those with solid organ transplant, hematopoietic stem cell transplant, and a number of autoimmune diseases. A panel of health care professionals involved in CC research and care was assembled to review and discuss existing literature on the subject and come to conclusions about screening based on available evidence and expe...
Source: Journal of Lower Genital Tract Disease - Category: OBGYN Tags: HPV-Associated Disease: Diagnosis and Management Source Type: research
Excerpted fromPrecision Medicine and the Reinvention of Human DiseaseDespite having the most advanced healthcare technology on the planet, life expectancy in the United States is not particularly high. Citizens from most of the European countries and the highly industrialized Asian countries enjoy longer life expectancies than the United States. According to the World Health Organization, the United States ranks 31st among nations, trailing behind Greece, Chile, and Costa Rica, and barely edging out Cuba [42]. Similar rankings are reported by the US Central Intelligence Agency [43]. These findings lead us to infer that acc...
Source: Specified Life - Category: Information Technology Tags: cancer cancer vaccines precision medicine prevention public health Source Type: blogs
(NEW YORK) — Two scientists who paved the way for widely used vaccines and another who discovered key players in cell growth have been awarded prestigious medical research awards. The Albert and Mary Lasker Foundation also announced Wednesday that it was giving its public service award to Planned Parenthood. Each award includes a $250,000 honorarium. The foundation’s clinical research award is shared by Dr. Douglas Lowy and John Schiller of the U.S. National Cancer Institute. In the early 1990s they began work that would eventually lead to vaccines against human papillomavirus, or HPV, which causes cervical can...
Source: TIME.com: Top Science and Health Stories - Category: Consumer Health News Authors: Tags: Uncategorized awards medical research onetime Planned Parenthood Science Source Type: news
Author Affiliations open 1 McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, Canada 2 Barcelona Institute for Global Health (ISGlobal), Barcelona, Spain 3 Universitat Pompeu Fabra (UPF), Barcelona, Spain 4 CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain 5 School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Canada 6 Epidemiology Research Program, American Cancer Society, Atlanta, Georgia, USA 7 Department of Economics, Brigham Young University, Provo, Utah, USA 8 Population Studies Division, Health Canada, Ottawa, Cana...
Source: EHP Research - Category: Environmental Health Authors: Tags: Research Source Type: research
Dr. Margaret Hamburg will step down from her post as Commissioner of the FDA next month. Hamburg and the FDA were busy in the few days before the announcement of her resignation, however. The Agency released a budget request for FY 2016, and Hamburg wrote a recap of the FDA's past year. Below is a summary of both.  FDA's Budget for FY 2016 In FDA's budget request, Hamburg stated that the agency is requesting a total of $4.9 billion, including a $148 million budget authority to: increase focus on improved oversight of imported foods, combat the growing threat of antibiotic resistance, promote the develop...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs
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