FDA approves SPOT-Light test for aggressive breast cancer

| July 9, 2008

The Wall Street Journal (7/9, D3, Chase) reports that on Tuesday, the Food and Drug Administration (FDA)…approved another new test for aggressive breast cancer called the SPOT-Light test." The test is manufactured by Invitrogen Corp. of Carlsbad, Calif., and a company spokeswoman "said [that] the test kits will be sold to hospital laboratories for about $1,400 for a packet of 20 kits."

According to the agency, it "cleared Invitrogen’s SPOT-Light test to count copies of the so-called HER2 gene in tumor tissue that regulates the growth of cancer cells," Bloomberg (7/9, Larkin) adds. Some breast cancer patients "have more than the two standard copies, and produce excess HER2 protein, causing cells to grow and divide too quickly." Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, stated, "When used with other clinical information and laboratory tests, this test can provide healthcare professionals with additional insight on treatment decisions for patients with breast cancer."

HealthDay (7/8, McKeever) noted that the "SPOT-Light test counts HER2 genes through a chemically stained sample of removed tumor observed under a standard microscope." Other 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 FDA’s "approval was on the basis of a study using tumor samples from patients with breast cancer in the United States and Finland," MedPage Today (7/8, Peck) explained. Various trials "confirmed that the test was effective in determining how many HER2 genes were in these patients."

WebMD (7/8, Hitti) pointed out that patients with cancer "who overproduce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells."


Category: General Healthcare News

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