Navigation Links
FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment
Date:6/14/2011

samples from 510 patients with breast cancer. This study showed that the test was effective in confirming that a patient's tumor sample contained more than the normal number of copies of the HER2 gene in 96 percent of the HER2 positive tumor samples. Patients with more than the normal number of copies of the HER2 gene are considered candidates for Herceptin therapy.

The study also showed that the test was effective at excluding the possibility that more than the normal number of copies of the HER2 gene were present in 92.3 percent of the HER2 negative tumor samples. Patients who do not have more than the normal number of copies of the HER2 gene are typically not candidates for Herceptin therapy. The ability to identify patients who are HER2-positive is a useful tool for physicians who may be considering treatment with Herceptin for their breast cancer patients.

Breast cancer is the second leading cause of cancer-related death among women. An estimated 207,090 new cases of breast cancer were diagnosed in the United States during 2010 and about 39,840 women died from the disease, according to the National Cancer Institute. About 20 percent of women diagnosed with breast cancer are HER2-positive.

Tucson, Ariz.-based Ventana Medical Systems manufactures the Inform Dual ISH test. Herceptin is marketed by South San Francisco based-Genentech, a member of the Roche Group.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Device Approvals and Clearances

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

NCI: Breast Cancer

http://www.cancer.gov/cancertopics/types/breast

<
'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/18/2013)... NEW YORK , May 18, 2013 /PRNewswire/ ... securities law firm, is investigating potential securities fraud ... (NASDAQ: AVEO). (Logo: http://photos.prnewswire.com/prnh/20120119/MM38856LOGO ... the Company and its executives violated federal securities ... regarding the Company,s Phase III drug trials for ...
(Date:5/17/2013)... 2013 Medical devices are any medical items ... In light of their different mechanisms, actions and regulatory ... complicated than drug trails due to their unique clinical ... of evaluating both safety and efficacy (which is left ... the same as the SFDA) evaluate MDs for both ...
(Date:5/17/2013)...  Sorrento Therapeutics, Inc. (OTCBB: SRNE; or STI) ... Business Technology Transfer Research (STTR) grant (#1R42AI098182-02) from ... (NIAID), a division of the National Institutes of ... antibody therapeutics to combat Staphylococcus aureus ... methicillin-resistant S. aureus (MRSA), was renewed ...
Breaking Medicine Technology:Faruqi & Faruqi, LLP Encourages Investors Who Suffered Losses In Excess Of $100,000 Investing In AVEO Pharmaceuticals, Inc. To Contact The Firm 2Statistical Challenges in Medical Device Trail Evaluation 2Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 2Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 3Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 4
... indicates that anti-inflammatory drugs may become a new tool ... leading global cause of death. In investigating a specific ... researchers used the Cardiochip, a gene analysis tool designed ... Center for Applied Genomics at The Children,s Hospital of ...
... March 14, 2012 OncoSec Medical Incorporated ... Medical System (OMS) ElectroOncology therapies to treat solid ... Institute in Santa Monica, CA, and Lakeland Comprehensive ... as enrolling sites, and investigators are screening patients ...
Cached Medicine Technology:Gene Chip, Invented by Children's Hospital of Philadelphia Scientist, Pinpoints New Target to Prevent Heart Disease 2Gene Chip, Invented by Children's Hospital of Philadelphia Scientist, Pinpoints New Target to Prevent Heart Disease 3OncoSec Initiates Two Additional Clinical Sites for Phase II Metastatic Melanoma Trial 2OncoSec Initiates Two Additional Clinical Sites for Phase II Metastatic Melanoma Trial 3OncoSec Initiates Two Additional Clinical Sites for Phase II Metastatic Melanoma Trial 4
(Date:5/19/2013)... The report “Feed Additives Market by Types, ... to 2017” published by MarketsandMarkets, defines and segments the ... of the global volume and revenue for the animal ... factors for the global market with analysis of trends, ... is segmented and revenue is forecasted on the basis ...
(Date:5/19/2013)... 19, 2013 The Pradaxa lawyers at ... was recently convened for hundreds of Pradaxa bleeding ... underway in U.S. District Court, Southern District of Illinois. ... on May 14th, the Conference addressed the status of ... during the Conference that Defendants submitted a list of ...
(Date:5/19/2013)... May 19, 2013 Farming methods have ... in the ground 10,000 years ago. Most recently, the ... productivity by using genetically engineered seeds and by applying ... a backlash to these techniques due to the adverse ... and a corresponding surge in interest in organic, sustainable ...
(Date:5/19/2013)... Seattle, WA (PRWEB) May 19, 2013 The ... updated weight loss secrets that help people get ... age, gender, and body shape. The program also is a ... loss diet plans. Besides, the author of this fat loss ... body transformation program, which can help people keep body fat ...
(Date:5/19/2013)... (PRWEB) May 19, 2013 Yeast infections are ... appear in sensitive areas of the human body. A new ... This new formula provides a unique method of application to ... spray solution is now provided to men and women searching ... naturally absorbed in the body through food and is stored ...
Breaking Medicine News(10 mins):Health News:Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets 2Health News:Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets 3Health News:Pradaxa Lawyers at Bernstein Liebhard LLP Report on Recent Status Conference in Federal Pradaxa Litigation 2Health News:Pradaxa Lawyers at Bernstein Liebhard LLP Report on Recent Status Conference in Federal Pradaxa Litigation 3Health News:Green Acre Aquaponics Introduces a Revolutionary Approach to Farm Education and Commercial Aquaponics 2Health News:Green Acre Aquaponics Introduces a Revolutionary Approach to Farm Education and Commercial Aquaponics 3Health News:Weight Loss Secrets | How “The Fat Loss Code” Helps People Gain A Healthy Life And Get In Shape - Health Review 2Health News:A Safe & Homeopathic Yeast Infection Relief by Yeastrol Now Available at HealthCareSupplementz.com with Massive Discount 2
... Hughes Medical Institute and the University of Chicago led ... not be all about unprompted mutations that occurred on ... with related species on the verge of extinction that ... which has remarkably contributed to successful evolution of humans. ...
... milk ice cream has just been launched in Rajasthan and ... milk face cream with its anti-wrinkle properties, it is now ... anti-bacterial properties. ,The ice cream comes in two ... by the Rajasthan-based Lokhit Pashu-Palak Sansthan (LPPS), an NGO that ...
... The lining of the womb may be damaged by heavy ... to recent research. // ,The study revealed that ... wall of the uterus difficult. ,The study was ... pregnancy rates for IVF using donated eggs for those who ...
... a heart attack Thursday and was admitted to hospital where ... 81, had complained of mild chest pains on Thursday morning ... of the National Heart Institute, the hospital said in a ... ,Mahathir had coronary artery bypass surgery in 1989 at the ...
... identical to HIV is endemic among wild gorillas in Africa ... to researchers on Wednesday. //,Statistics have shown that around 40 ... monkeys in Africa infected with simian immunodeficiency virus (SIV) are ... strains of the virus in humans the source of the ...
... the meager support for the increase in the number ... one among three individuals thought it would benefit healthcare. ... the 183-bed Beacon Hospital in Dublin are the recent ... were queried, only 34% expressed optimism regarding the increase ...
Cached Medicine News:Health News:Strong Evidence Suggests Incidence Of Mating Of Ancestors With Neanderthals 2Health News:Ice Cream made of Camel Milk Launched in Rajasthan 2Health News:Monkey Virus Identical to HIV Endemic in Gorillas 2
... The EBV laboratory diagnosis is generally confirmed ... Severity of the disease however, is not indicated ... IM occurs in 10 - 20 percent of ... EBV are necessary to fully ascertain the stage ...
... IDI-Strep B test can lower healthcare costs ... hospital stays. By identifying mothers colonized with ... more targeted and effective antibiotic prophylaxis. This ... of infants and reduce unnecessary antibiotic use ...
... Needle is specially designed to help you ... reliable core sample. All needles are engineered ... polished surfaces for smooth entry and exit. ... needle sizes assures an ideal match with ...
... Used to obtain multiple core biopsies of ... Biopsy Needle design facilitates one-handed control. Precise, ... sample. Beveled point stylet permits easy penetration ... surrounding tissue. Sharp cutting edge of cannula ...
Medicine Products: