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Invitrogen Corporation, a provider of essential life science technologies for research, production and diagnostics, has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its SPOT-Light(R) HER2 CISH Kit, indicated as an aid in the assessment of breast cancer patients for whom trastuzumab (Herceptin(R)) treatment is being considered.
The approval marks the first PMA that Invitrogen has received from the US FDA.
The introduction of the SPOT-Light(R) HER2 CISH Kit clinical setting will have a direct impact on healthcare. The US FDA's approval of this kit for the U.S. market also demonstrates our ability to apply Invitrogen technologies into high-growth applied markets. 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. |
