Navigation Links
FDA Approves Test That Spots HER2-Positive Breast Cancers
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.

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: 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 HER2-Positive Breast Cancers
(Date:10/13/2017)... ... October 13, 2017 , ... As health professionals work ... as “patient engagement.” The patient is doing more than filling out a survey; in ... “There is an increasing emphasis in health care and research on the importance of ...
(Date:10/13/2017)... EDWARDSVILLE, Ill. (PRWEB) , ... ... ... University Edwardsville School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and ... educated healthcare professionals on guideline updates for the primary prevention of cardiovascular ...
(Date:10/13/2017)... ... , ... Ellevate Network, the leading network for professional women, brought together some ... at their inaugural Summit in New York City in June. The event was livestreamed ... over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... ... ... Journey: From the Mountains to the Mission Field”: the story of a missionary couple ... From the Mountains to the Mission Field” is the creation of published author, Carole ... and currently teaches a class of ladies at her church, which she has taught ...
(Date:10/12/2017)... WAUSAU, Wis. (PRWEB) , ... October 12, 2017 ... ... formulated standard products to meet the demand of today’s consumer and regulatory authorities ... team of probiotic experts and tested to meet the highest standard. , ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... Halo Labs announces the European launch of their new low volume, ... 2017 in Cambridge, U.K on October 4th. ... samples with unprecedented speed and sensitivity while using far less sample ... ... system ...
(Date:9/27/2017)... -- Commended for their devotion to personalized service, SMP Pharmacy Solutions ... in the South Florida Business Journal,s 50 Fastest-Growing Companies, and ... the national specialty pharmacy has found its niche.  To that ... be honored by SFBJ as the 2017 Power Leader in ... receive his award in October, Bardisa said of the three ...
(Date:9/23/2017)... HORSHAM, Pa. , Sept. 22, 2017 ... received a complete response letter from the U.S. Food ... (BLA) seeking approval of sirukumab for the treatment of ... response letter indicates additional clinical data are needed to ... of moderately to severely active RA. ...
Breaking Medicine Technology: