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.
fda
"I think Cancer Chat is a brilliant idea" - Rebekah Gibbs, TV personalityThe award-winning website attracts around one million visitors a month and Cancer Research UK hopes that some of these visitors will also want to post comments on the Cancer Chat forum.
For those who do not have access to computers and have questions about cancer, the charity's team of cancer information nurses are available during office hours to talk over patients' concerns on the phone.
Kate Arnold, Cancer Research UK's director of patient information, said: "From talking to patients we have found that there is a gap in peer-to-peer support for people affected by cancer. By providing an opportunity for people to share information and experiences about cancer we hope to help meet that demand.
"We also want people to feel safe in the knowledge that if someone intentionally or mistakenly relays information that our experts know to be flawed or misleading - "then they will post a message to that effect. This means that people with cancer will get the information they need."
infoncerresearchuk