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news.Invitrogen has received the FDA premarket approval for its Spot-Light Her2 CISH kit, indicated as an aid in the assessment of breast cancer patients for whom trastuzumab treatment is being considered.
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Invitrogen’s Spot-Light Her2 CISH 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% of breast cancers and predicts whether a breast cancer patient is a candidate for trastuzumab treatment.
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.
Greg Lucier, chairman and CEO of Invitrogen, said: “The introduction of the Spot-Light Her2 CISH kit is another example of how Invitrogen technologies can be used in a clinical setting to have a direct impact on healthcare. The FDA’s approval of this kit for the US market also demonstrates our ability to apply Invitrogen technologies into high-growth applied markets.”