Navigation Links
FDA Approves Genetic Test for Breast Cancer
Date:7/8/2008

Kit will help identify which patients are most likely to respond to Herceptin

TUESDAY, July 8 (HealthDay News) -- A genetic test to determine whether a breast cancer patient is likely to respond to treatment with the drug Herceptin (trastuzumab) has been approved by the U.S. Food and Drug Administration.

The SPOT-Light HER2 CISH kit helps calculate how many copies of the HER2 gene, which regulates the growth of cancer cells, are in tumor tissue. A healthy breast cell should have two copies of the HER2 gene, but patients with breast cancer may have many more. Since the gene signals cells when to grow, divide and make repairs, too many copies may cause cells to grow and divide too rapidly.

The drug Herceptin targets HER2 protein, helping stop the growth of such cancer cells in breast cancer patients overproducing that particular protein.

"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," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in an agency news release.

The SPOT-Light test counts HER2 genes through a chemically stained sample of removed tumor observed under a standard microscope. Previous tests required more expensive and complex fluorescent microscopes. The SPOT-Light also allows labs to store the tissue for later reference, a feature not possible with previously available tests.

The Invitrogen Corp., of Carlsbad, Calif., produces SPOT-Light. San Francisco-based Genentech manufactures Herceptin.

More information

The National Cancer Institute has more about Herceptin.



-- Kevin McKeever



SOURCE: U.S. Food and Drug Administration, news release, July 8, 2008


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... February 10, 2016 , ... ... health care communications company offering education, research and medical media, has launched ... specialists working in infectious diseases. , As the all-inclusive resource for infectious ...
(Date:2/10/2016)... Walton Beach, Florida (PRWEB) , ... February 10, ... ... the innovative weather-forecasting company is unveiling its revolutionary new 2.0 version at the ... platform, MetLoop has “put the power of the world's most advanced weather technology ...
(Date:2/10/2016)... ... February 10, 2016 , ... InDemand Interpreting , a ... partnered with Heart City Health Center to improve access to language ... City Health Center has provided the Elkhart community with access to high quality, ...
(Date:2/10/2016)... ... 10, 2016 , ... Compliancy Group LLC is pleased to ... throughout the country. The Guard was specifically designed to handle each element required ... regulatory updates, and compliance coaching. , In addition to meeting the compliance needs ...
(Date:2/10/2016)... , ... February 10, 2016 , ... Emergency rooms provide ... to find. Unfortunately, this can leave patients with dental emergencies at risk of losing ... now offering emergency dental care. , Common dental emergencies include:, ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... , February 10, 2016 Puerto Rico ... Puerto Rico Healthcare and Life Sciences Report 2016 ... page Puerto Rico Healthcare and Life Sciences Report 2016 ... into the fifth largest territory in the world for pharma ... device and diagnostics manufacturing, and more universities per square mile ...
(Date:2/10/2016)... Feb. 10, 2016 Mast Therapeutics, Inc. ... clinical-stage therapies for sickle cell disease and heart failure, ... of 29,090,910 units at a price to the public ... share of the Company,s common stock and one warrant ... at an exercise price of $0.42 per share. The ...
(Date:2/10/2016)... , Feb. 10, 2016  Silicon Biosystems Menarini ... products that help uncover the biological complexities of ... Inc., a developer of innovative technologies for genomics ... partnership aimed at enabling translational researchers to obtain ... couple hundred tumor and normal cells in an ...
Breaking Medicine Technology: