Another HER2 Test Receives FDA Approval

The FDA has given Invitrogen pre-market approval for company’s new test for the HER2 gene, commonly expressed in breast cancer patients.

The kit is based on a technology called chromogenic in situ hybridization (CISH). The test uses a DNA probe for the HER2 gene, which is amplified in 18 to 30 percent of breast cancers and predicts whether a breast cancer patient is a candidate for trastuzumab treatment. Current medical practice requires that all patients who are considered for trastuzumab treatment be tested for HER2 amplification or overexpression. CISH test results are visualized under a standard bright-field microscope, as opposed to fluorescent in situ hybridization tests, in which the results must be visualized using a fluorescent microscope. This specialized microscope frequently requires that the analysis is done at a reference lab. In addition, HER2 CISH test results are quantifiable; removing the subjectivity inherent in tests based on immunohistochemistry (IHC) interpretation schemes.
“The current protocol for assessing HER2 gene status is for labs to initially screen tissue samples with immunohistochemistry to gauge whether there is an overabundance of the HER2 protein, as an indirect measure of gene amplification,” said August Sick, vice president and general manager of Invitrogen’s Cellular Analysis Business. “In the case of an inconclusive test, the samples are typically sent to an outside lab for confirmation. Because the SPOT-Light(R) HER2 CISH Kit doesn’t need specialized equipment, any histology lab can now assess amplification of the HER2 gene while simultaneously examining tissue morphology.”

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Image courtesy Invitrogen Corp.: SPOT-Light HER2 Probe…