Will Monogram's HER2 Test Hit The Mark?

On the same day that FDA approved Invitrogen's SPOT-Light test, South San Francisco-based Monogram Biosciences announced plans to make its own HER2 assay available to physicians as a lab service July 15. Monogram's data has not been reviewed by FDA, but the firm says its HERmark breast cancer assay may be more accurate than tests on the market. HERmark results have been correlated to immunohistochemistry and to fluorescence and chromogenic in situ hybridization results from more than 1,000 patients, showing "a high degree of concordance," according to Michael Bates, VP-clinical research. Monogram also says HERmark identifies patients with high HER2 levels who were identified as HER2-negative in other assays and those with low HER2 levels who were deemed positive. The assay uses specialized antibody tags to quantify the levels of HER2 protein, including protein that has bound together to create a new molecule, to generate a report that indicates a positive, negative, or equivocal HER2 status. HERmark is not an FDA-approved kit, but will be performed exclusively out of Monogram's laboratory, which is validated by the federal government to develop "home brew" diagnostic tests ("The Gray Sheet" Aug. 13, 2007, p. 5).