FDA approves inclusion of gene test in Herceptin labeling.(Food and Drug Administration)

2002 NOV 7 - (NewsRx.com & NewsRx.net) -- Abbott Laboratories (ABT) anticipates that more breast cancer patients will benefit from use of its Vysis PathVysion fluorescence in situ hybridization (FISH) test as a result of the U.S. Food and Drug Administration's (FDA) approval to include information about it in the labeling for Herceptin, a monoclonal antibody treatment for women with metastatic breast cancer.

PathVysion represents one of the first examples of genomic disease management detecting HER-2/neu gene status as the means to accurately identify which women are potential candidates for Herceptin.

"This is promising news for both patients and physicians alike," said Michael Press, MD, PhD, the Harold E. Lee Chair Professor for Cancer Research, Department of Pathology, Norris Comprehensive Cancer Center, University of Southern California. "Gene amplification, as determined by FISH, provides the most accurate method for diagnosing HER-2 status, permitting those women with the molecular target for Herceptin to be most appropriately treated."

The presence of multiple copies of the HER-2 gene plays a pivotal role in the rapid growth of tumor cells in 25 to 30% of breast cancer patients. Women with HER-2 positive breast cancer also experience resistance to therapy and decreased survival. Determination of HER-2 gene status is a critical tool for selecting therapeutic options, because certain breast cancer treatments are more appropriate when multiple copies of the gene are found. A diagnostic test is required to identify which women have HER-2 positive disease and are candidates for treatment with Herceptin.

"We're pleased by the FDA's decision to include PathVysion as part of Herceptin's label and believe it opens the door for this important test to become more widely used in the selection of appropriate therapy for women with breast cancer," said ...