Navigation Links
FDA Approves Test That Spots Aggressive Breast Cancer

TUESDAY, June 14 (HealthDay News) -- A new genetic test that helps determine if breast cancer patients are good candidates for treatment with the drug Herceptin was approved Tuesday by the U.S. Food and Drug Administration.

About 20 percent of breast cancers are HER2-positive, and respond well to Herceptin (trastuzumab).

The new Inform Dual ISH test reveals the number of copies of the HER2 gene in tumor tissue.

"When used with other clinical information and laboratory tests, this test can provide health-care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health, said in an agency news release.

The FDA's approval of the test was based on a U.S. study that included tumor samples from 510 breast cancer patients. The study found that the test was effective in confirming a higher than normal number of copies of the HER2 gene in 96 percent of the HER2-positive tumor samples.

The test was also effective in excluding the possibility that more than the normal number of copies of the HER2 gene were present in 92.3 percent of HER2-negative tumor samples, according to the FDA.

Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City, said the new test will help "in acquiring the data about a woman's cancer more quickly and efficiently. This will help speed the process of formulating a treatment plan during a time when a woman is searching for answers regarding her future.

"The faster a treatment plan is formulated, the easier it is for a woman to deal with her diagnosis. When faced with too many unknowns, the diagnosis of breast cancer can be overwhelming. Because this test can be performed in a standard lab, the information regarding HER2 status will be known quickly, and a woman will know if her treatment will be over within a few months, or might go on for a full year," Bernick said.

Dr. Freya Schnabel, director of Breast Surgery at NYU Langone Medical Center, said: HER2 testing is an "important part of the assessment of breast cancer tissue, because it tells us important information about the biology of the tumor and also helps identify the subset of patients who would benefit from treatment with Herceptin. At this point, testing for HER2/neu frequently involves two levels of testing and there is sometimes lack of agreement between test results, making a patient's status unclear."

The new test is made by Tucson, Ariz.-based Ventana Medical Systems.

More information

The American Cancer Society has more about breast cancer.

-- Robert Preidt

SOURCES: Stephanie Bernik, M.D., chief of surgical oncology, Lenox Hill Hospital, New York City; Freya Schnabel, M.D., director of Breast Surgery, NYU Langone Medical Center, New York City; U.S. Food and Drug Administration, news release, June 14, 2011

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Kaiser Permanente Approves $170 Million in Community Benefit Grants in 2009
2. The American Association of Anatomists approves guidelines for body donation programs
3. Golden Meditech Shareholders Approves of Name Change
4. New Jersey Approves Initiative to Expand the Number of Wound Care Certified Professionals
5. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
6. House of Representatives Approves Health-Care Reform Bill
7. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
8. FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
9. FDA approves first human neural stem cell clinical trial to treat brain tumors
10. Early detection of cancer: The FDA approves procedure discovered by EPFL researchers
11. FDA approves Merz Pharmaceuticals Xeomin (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm
Post Your Comments:
Related Image:
FDA Approves Test That Spots Aggressive Breast Cancer
(Date:6/27/2016)... ... 27, 2016 , ... "FCPX editors can now reveal their media with growing ... said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color brings ... users can now reveal the media of their split screens with growing colorful panels. ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in ... ways they remain in the eye of the beholder, according to experts who offered ... The American Journal of Managed Care. For the full issue, click here . ...
(Date:6/26/2016)... Michigan (PRWEB) , ... June 26, 2016 , ... ... to fertility once they have been diagnosed with endometriosis. These women need a ... they also require a comprehensive approach that can help for preservation of fertility ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research and ... Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data derived ... Assessment of major trends with potential impact on the market ... of market segmentation which comprises of sub markets, regional and ...
(Date:6/23/2016)... Research and Markets has announced the ... report to their offering. ... favourable commercial environment for MedImmune to enter. The US ageing ... serve to drive considerable growth for effective anti-influenza medications. The ... sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... 23, 2016 , , , ... 7, 2016 , , , , LOCATION: , , , ... , , , EXPERT PANELISTS:  , , , Frost & Sullivan,s ... Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program ... global pharmaceutical industry is witnessing an exceptional era. Several new demand ...
Breaking Medicine Technology: