Navigation Links
FDA Approves Test That Spots Aggressive Breast Cancer
Date:6/14/2011

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:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves Test That Spots Aggressive Breast Cancer
(Date:10/13/2017)... LEXINGTON, Ky. (PRWEB) , ... October 13, 2017 , ... ... MD, MPH to become its next President and Chief Executive Officer, succeeding Dr. James ... and CEO Elect beginning July 1, 2018 until Dr. Puffer’s retirement at the end ...
(Date:10/13/2017)... ... ... Apple Rehab Shelton Lakes , which specializes in the delivery of sub-acute ... of a disaster drill on October 3rd. , Apple Rehab participated with the Shelton ... well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). The LTC-MAP ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at ... of the most popular and least understood books in the Holy Scriptures, Revelation. The ... that have baffled scholars for centuries. Many have tossed it off as mere rubbish, ...
(Date:10/12/2017)... WILMINGTON, Del. (PRWEB) , ... October 12, 2017 ... ... technology and advisory services for healthcare compliance program management, will showcase a range ... and National Association for Assisted Living (NCAL) Convention and Expo to be held ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of ... Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, ... In honor of Morris F. Collen, a pioneer in the field of medical informatics, ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... their devotion to personalized service, SMP Pharmacy Solutions announces their ... South Florida Business Journal,s 50 Fastest-Growing Companies, and listed for ... specialty pharmacy has found its niche.  To that end, the ... by SFBJ as the 2017 Power Leader in Health Care. ... award in October, Bardisa said of the three achievements, "It,s ...
(Date:9/22/2017)... 2017  As the latest Obamacare repeal effort moves ... (R-LA) and Lindsey Graham (R-SC) medical ... device industry is in an odd place.  The industry ... excise tax on medical device sales passed along with ... patients, increased visits and hospital customers with the funding ...
(Date:9/18/2017)... Sept. 18, 2017 EpiVax, Inc. ... bioinformatics and immune engineering, today announced a ... A (H7N9) vaccine. ... seasonal influenza and presents a challenge for ... exposure to be effective. Using state-of-the-art bioinformatics and ...
Breaking Medicine Technology: