cobas HPV Test – P100020 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm254518.htm Product Name: cobas HPV Test PMA Applicant: Roche Molecular Systems, Inc. Address: 4300 Hacienda Drive, PO Box 9002, Pleasanton, CA 94588-0900 Approval Date: April 19, 2011 Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/p100020a.pdf What is it? The cobas HPV Test is an automated test run on the cobas 4800 system which is used to identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer . The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). If test results are positive, the patient is likely infected with HPV. How does it work? DNA is isolated from a scrape of cells from a woman’s cervix and is subsequently mixed in reaction wells with primers and probes that specifically recognize and amplify HPV DNA. This reaction produces fluorescence, which is then measured to determine the presence of HPV in the cervical sample. When is it used? Test results may be used in women age 30 and over, or women age 21 and older with borderline cellular (cytology) results to determine the need for additional follow-up and diagnostic procedures. Test results should be used together with the physician’s assessment of cytology history, other risk factors, and professional guidelines. What will it accomplish? The test provides information to physicians on a patient’s risk for developing cervical cancer. Although HPV infection is very common, and usually self-resolving, if HPV DNA is present, the patient is in a higher risk category for developing cervical cancer than if HPV is not detected. When should it not be used? The cobas HPV Test is not intended: for use as a screening device for women under age 30 with normal cervical cytology. to substitute for regular cervical cytology screening. for use in determining the need for treatment of the cervix in the absence of high-grade cervical dysplasia . Patients who are HPV 16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines. The use of this test has not been evaluated for the management of women with prior treatment of the cervix, those who had a hysterectomy, or who are pregnant, or who have other risk factors (such as, HIV positive, immunocompromised, history of Sexually Transmitted Infection (STI)). Additional information : Summary of Safety and Effectiveness and labeling are available online. Other Resources: CDC - Sexually Transmitted Diseases (STDs) ASCCP - Consensus Guidelines - 2006 Consensus Guidelines for the Management of Women with Abnormal Cervical Screening Tests - - Page Last Updated: 05/06/2011
德国海德堡与匈牙利布达佩斯10月12日消息：作为免疫治疗技术先行者的Genetic Immunity公司（OTCBB：PWRV）与海德堡德国癌症研究中心签订了一项联合开发基于DNA技术治疗人类乳头状瘤病毒（HPV）感染疫苗的协议。该病毒会引起的子宫颈癌及肛门，阴茎，外阴，阴道和口咽等部位的癌症。目前的HPV疫苗（Cervarix和Gardasil）只有对病毒自身的预防功能，而不具有人乳头瘤病毒HPV引发疾病的治疗效果。 由Lutz.Gissmann教授的领导DKFZ基因组修饰和癌变过程团队，将开展一个临床前研究项目，用遗传免疫的纳米医学配方和朗格汉斯细胞定位管理技术评估DKFZ的HPV-特定DNA质粒的疗效。 DKFZ是肿瘤病毒学的世界领先科研单位，哈拉尔德·楚尔·豪森正是因为对人乳头状瘤病毒引发的子宫颈癌的研究被授予诺贝尔医学奖。曾为德国癌症研究中心前科学主任的楚尔·豪森率行发现子宫颈癌是因病毒感染而引起。由他的研究成果诞生的疫苗可防止最常见女性癌症之一种。楚尔·豪森与发现导致艾滋病HIV病毒的弗朗索瓦丝•巴尔 - 西诺西和吕克·蒙塔尼分享了当年的诺贝尔医学奖。 “这种癌症新的疫苗将有巨大的市场价值，因为过去所开发的疫苗在用于治疗由人乳头瘤病毒引起的症状时并不具有防癌的功能。我们现在想对那些已经因为性爱可能遭受HPV感染的人群也能提供防护。“ 遗传免疫公司CEOJulianna Lisziewicz博士说。 10/12/12 - DKFZ and Genetic Immunity Sign Collaboration Agreement to Develop HPV Therapeutic Vaccine HEIDELBERG, GERMANY and BUDAPEST, HUNGARY (Marketwire) 10/12/12 Genetic Immunity (OTCBB: PWRV), a leader in immunotherapy technology product development, and DKFZ (German Cancer Research Center, Heidelberg, Germany) signed a collaborative agreement to develop a DNA-based vaccine for the treatment of Human Papilloma Virus (HPV) infection that causes cervical cancer and other cancers of the anus, penis, vulva, vagina, and oropharynx. Present HPV vaccines (Cervarix, Gardasil) have no therapeutic effect on HPV-related diseases, so they will not treat existing diseases or conditions caused by HPV. The Division of Genome Modifications and Carcinogenesis led by Prof. Dr. Lutz Gissmann will initiate a preclinical research program to evaluate the therapeutic efficacy of the DKFZ's HPV-specific plasmid DNA using Genetic Immunity's nanomedicine formulation and Langerhans cell-targeting administration technologies. DKFZ is a world leading research center in tumor virology. Harald zur Hausen was awarded the Nobel Medicine Prize for his work on HPV-caused cancer of the cervix. Zur Hausen, former Scientific Director of the German Cancer Research Center, is recognized for finding that cervical cancer is caused by viral infections. His research made it possible to develop a vaccine against one of the most frequent cancers in women. Zur Hausen shared the Nobel Prize for Medicine with Françoise Barré-Sinoussi and Luc Montagnier for discovering HIV, the virus that causes AIDS. "There is a huge unmet medical need for such cancer vaccine, because vaccines we have developed earlier do not provide protection against cancer when used for treatment of existing conditions caused by HPV. Our goal is to provide protection against cancer for patients after the onset of sexual activity, after they might be exposed to HPV," said Dr. Julianna Lisziewicz, CEO of Genetic Immunity. Genetic Immunity has successfully tested in clinical trials DermaVir, a candidate immunotherapy for the cure of HIV. This new collaboration is using the clinically proven technology expanding the pipeline to another deadly viral disease that causes cancer. The partners will test whether HPV-specific memory T cells induced by Genetic Immunity's nanomedicine products could protect against cancer after infection has occurred. "We found that Genetic Immunity technology is unique to target the vaccine DNA into the nucleus of the Langerhans cells. We believe that it will provide a breakthrough in cancer immunotherapy. We pioneered HPV prophylactic vaccines with new innovations and we would like to expand this tradition to therapeutic setting," said Dr. Prof. Gissmann of DKFZ. Genetic Immunity is a wholly owned subsidiary of Power of the Dream Ventures, Inc. (OTCBB: PWRV). About Genetic Immunity Genetic Immunity, part of Power of the Dream Ventures, Inc. (PWRV), is a clinical stage technology company committed to discovering, developing, manufacturing and commercializing a new class of immunotherapeutic biologic drugs for the treatment of viral infections, cancer and allergies. Our Langerhans cell-targeting nanomedicines are exceptional in both safety and immune modulating activity boosting specific Th1-type central memory T cells. These are essential to eliminate infected cells or cancerous cells, and balance the immune reactivity in response to allergens. In 1988 Drs. Lisziewicz and Lori founded Genetic Immunity in the US after they described the 1st patient whose immune system was boosted to control HIV after treatment interruption (Lisziewicz et al. New England Journal of Medicine 1999) that lead to the invention of DermaVir. The Company's innovative technology team directed by Dr. Lisziewicz, a champion of immune boosting therapies, is now headquartered in Budapest, Hungary. She has been invited into the Scientific Advisory Board of the HIV Cure Initiative led by Francoise Barre-Sinoussi Nobel Prize Laureate for her HIV research in 2009. For more information please visit http://www.geneticimmunity.com About DKFZ The German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) with its more than 2,500 employees is the largest biomedical research institute in Germany. At DKFZ, more than 1,000 scientists investigate how cancer develops, identify cancer risk factors and endeavor to find new strategies to prevent people from getting cancer. They develop novel approaches to make tumor diagnosis more precise and treatment of cancer patients more successful. Jointly with Heidelberg University Hospital, DKFZ has established the National Center for Tumor Diseases (NCT) Heidelberg where promising approaches from cancer research are translated into the clinic. The staff of the Cancer Information Service (KID) offers information about the widespread disease of cancer for patients, their families, and the general public. The center is a member of the Helmholtz Association of National Research Centers. Ninety percent of its funding comes from the German Federal Ministry of Education and Research and the remaining ten percent from the State of Baden-Württemberg. Add to Digg Bookmark with del.icio.us Add to Newsvine Contact: Dr. Zsolt Lisziewicz Chief Operating Officer Genetic Immunity Phone: +36-1-272-0364 Cell: +36-30-211-6402 Email: Email Contact
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5920a4.htm FDA Licensure of Bivalent Human Papillomavirus Vaccine (HPV2, Cervarix) for Use in Females and Updated HPV Vaccination Recommendations from the Advisory Committee on Immunization Practices (ACIP)
标签: HPV
