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FDA approves new test to predict trastuzumab candidates
The test probes for HER-2 genes using chromogenic in situ hybridization technology.
Earlier today, the FDA announced the approval of a novel test that detects HER-2 gene intensification in formalin-fixed, paraffin-embedded tumor tissues.
Manufactured by Invitrogen Corporation, the SPOT-Light HER2 CISH kit can aid physicians in the treatment decision-making process by predicting which patients will be good candidates for trastuzumab (Herceptin, Genentech), according to a July 8 press release.
The FDA approved the test based on a study conducted using tumor tissue from patients with breast cancer in the United States and Finland.
Under a brightfield microscope, the kit can simultaneously detect HER-2 gene amplification and morphology using Zymed Laboratories’ subtraction probe technology. According to the FDA press release, the tissue samples can be stored for future reference, unlike existing tests. – by Stacey L. Adams