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Invitrogen Gains FDA Premarket Approval for HER2 Test

NEW YORK (GenomeWeb News) – Invitrogen said today that it has received US Food and Drug Administration premarket approval for its SPOT-Light HER2 CISH kit, which can be used to assess whether breast cancer patients should be treated with Genentech’s Herceptin (trastuzumab).
Invitrogen said that this is the first premarket approval that it has received from the FDA.
The SPOT-Light kit is based on chromogenic in situ hybridization, or CISH, which the company said offers a number of advantages over currently available HER2 tests based on immunohistochemistry or fluorescent in situ hybridization.
CISH test results are visualized under a standard bright-field microscope, while FISH tests use a fluorescent microscope, which “frequently requires that the analysis is done at a reference lab,” the company said. Invitrogen added that HER2 CISH test results are “quantifiable,” as opposed to IHC interpretation, which is subjective.
Because the HER2 CISH kit doesn't require specialized equipment, “any histology lab can now assess amplification of the HER2 gene while simultaneously examining tissue morphology," said August Sick, vice president and general manager of Invitrogen's Cellular Analysis Business, in a statement.
Jeffrey Ross, chair of the department of pathology and laboratory medicine at Albany Medical College, said in a statement that the CISH method has shown a “high concordance” with FISH-based assays for the identification of HER2 gene amplification.
“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, director of the FDA’s Center for Devices and Radiological Health, in a statement.
The FDA said that it based its approval of the test on a study using tumor samples from patients with breast cancer in the US and Finland. "These studies confirmed that the test was effective in determining how many HER2 genes were in these patients," the agency said. 
Invitrogen said it will begin offering the HER2 CISH kit in the US in mid-August.

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