Georgia Division of Public Health confirms novel H1N1 cases

The Centers for Disease Control and Prevention Friday awarded validation to the Georgia Public Health Lab (GPHL) to perform novel H1N1 virus confirmatory testing.

This means that the Georgia Public Health Lab has been able to quickly test and confirm all the probable samples in their facility.

"In total Georgia has 25 confirmed cases of novel H1N1 virus. The surge in cases is mainly due to the probables cases now being considered confirmed," said Dr. Sandra Ford, acting director of the Georgia Division of Public Health (GDPH).

Five of the cases were tested out-of-state.

"The Georgia Division of Public Health is actively engaged in the analysis and research on this new virus," said Dr. Ford. "State and federal public health agencies have enough information about this virus to assess its effects on individuals. Now we have started to focus our efforts in testing those who present the most severe cases, such as the hospitalized."

As part of state influenza surveillance system the lab will also test samples submitted by its Influenza Sentinel Providers Surveillance Network, as well as samples sent by private providers to the Public Health Districts.

Respiratory illnesses circulate in Georgia all year round. Current influenza surveillance shows that both seasonal flu virus and the novel H1N1 virus are present in Georgia. Frequent hand washing, covering coughs and sneezes and staying home when ill are the most effective ways to avoid getting sick.

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FDA Approves New Genetic Test for Patients with Breast Cancer

The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.

“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,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

The SPOT-Light test counts the number of HER2 genes in a small sample of removed tumor. The removed piece is stained with a chemical that causes any HER2 genes in the sample to change color. This color change can be visualized under a standard microscope, eliminating the need for the more expensive and complex fluorescent microscopes required to read assays already on the market. Unlike existing tests, the SPOT-Light allows labs to store the tissue for future reference.

Patients who over-produce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells.

The FDA based its approval of the SPOT-Light test on a study using tumor samples from patients with breast cancer in the United States and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.

SPOT-Light is manufactured by Invitrogen Corp. of Carlsbad, Calif. Herceptin is manufactured by Genentech, of San Francisco, Calif.