FDA approves HER-2 gene diagnostic assay

The FDA has approved the Inform HER2 Dual ISH DNA probe cocktail assay to determine whether women with breast cancer are HER-2–positive, according to a press release.

This is the first fully automated assay approved by the FDA that determines HER-2 gene status in breast cancer to help health care professionals assess patients who may benefit from treatment with trastuzumab (Herceptin, Genentech).

The HER2 Dual ISH assay (Vertana Medical Systems) detects copies of HER-2 and chromosome 17 in breast tumor tissue on a single slide using a standard microscope. HER-2 and chromosome 17 are stained in different colors, so they may be counted in the lab, and unlike fluorescent in situ hybridization assays, the bright-field detection technology produces signals that do not fade in time. This allows results to be stored and shared between pathologists.

The FDA based its approval of the assay on a US study that included tumor samples from 510 patients with breast cancer. In the study, the assay confirmed that 96% of the HER-2–positive tumor samples contained more than the normal number of copies of the HER-2 gene. The test also effectively excluded the possibility that more than the normal number of copies of the HER-2 gene were present in 92.3% of the HER-2–negative tumor samples.

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