HER-2/Neu Blood Test Cleared by FDA

A new serum test that measures the circulating levels of the HER-2/neu oncoprotein for use in the follow-up and monitoring of patients with metastatic breast cancer has been cleared by the U.S. Food and Drug Administration (FDA).

The new test is from Bayer Diagnostics (Tarrytown, NY, USA). Traditional HER-2/neu testing is generally limited to tissue from primary breast cancer, notes Bayer, and does not provide information on HER-2/neu status in women with recurrent, metatastic breast cancer. The introduction of the company's microtiter plate enzyme-linked immunosorbent assay (ELISA) using a serum sample offers a less-invasive diagnostic tool and provides a current assessment of a woman's HER-2/neu status over the course of the disease.

Some studies suggest that in certain breast cancer patients, persistently rising HER-2/neu values may be associated with aggressive cancer and poor response to therapy, while decreasing levels may be indicative of effective therapy. The clinical utility of the serum test as a prognostic indicator has not yet been fully established but is under investigation, says Bayer. "Bayer's strategy is to identify key oncoproteins and tumor markers from which to develop new tests, and to link these test with the appropriate treatment options,” said Hans Hiller, Ph.D., senior vice president of the laboratory testing segment of Bayer Diagnostics.



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