The TOP2A gene plays a role in DNA replication. The TOP2A FISH pharmDx test uses fluorescently labeled DNA probes to detect or confirm gene or chromosome abnormalities, a technology known as fluorescent in situ hybridization (FISH).

The recurrence of cancer depends partly on certain genes whose activity may be altered by changes in the number of gene copies in the tumor. Changes in the TOP2A gene in breast cancer cells mean there is an increased likelihood that the tumor will recur or that long-term survival will be decreased.

"When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on the likely clinical course for breast cancer patients," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "It can also provide valuable information to assist health care providers and patients in better understanding the biology of breast cancer disease."

The test is suitable for breast cancer patients who are premenopausal or for whom tumor characteristics, such as tumor size or lymph node involvement, suggest a higher likelihood of tumor recurrence or decreased survival.

The FDA reviewed evidence that the test has been properly validated for its intended use.

The product was studied in Danish patients who were treated with chemotherapy after removal of a breast tumor. The test is conducted on a small piece of the removed tumor. The removed piece is stained with the FISH chemicals and studied under a microscope.

The company submitted data from a study using tumor samples and clinical data from 767 patients with high risk tumors at 21 centers in Denmark. These studies confirmed that the test was useful in estimating time to local or distant recurrence and overall survival in women who received certain chemotherapy regimens assisting in the treatment of the disease.

The product is manufactured by Dako Denmark A/S (Glostrup, Denmark).

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In the UNC study, 115 undergraduate nursing students were first given a questionnaire that asked about the participants' prior level of contact with people with anorexia nervosa. Then each was given a one-page information sheet. Roughly half received an information sheet that emphasized what is currently known about the biological and genetic contributions to the development of the disorder. The other half received an information sheet that emphasized sociocultural explanations for the causes of the illness.

After the students read the information they were given a second questionnaire in which they were asked to indicate on a seven-point scale the extent to which eight factors contributed to the development of anorexia. These factors were poor living habits, parenting, biological factors, lack of social support, self discipline, society's thin ideal, genetic factors and vanity.

The questionnaire also asked other questions intended to measure the participants' attitudes toward people with anorexia, including whether or not they would sign a petition asking insurance companies to provide equal coverage for anorexia as they do for other medical conditions.

The results showed that individuals in the group given the sociocultural explanation were more likely to agree with the statement, They are to blame for their condition. They were also more likely to agree that parenting, vanity and lack of social support were causes of anorexia nervosa.

The study concluded that people who were presented with even minimal information about the biological and genetic underpinnings of (anorexia nervosa) did tend to blame people with anorexia for their condition less than are those who were only informed of the sociocultural factors that may contribute to the disorder.

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