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Back To Vidyya New Breast Cancer Monitoring Test Receives FDA Clearance

Serum HER-2/NEU Oncoprotein Test

Bayer Diagnostics announced today the US Food and Drug Administration (FDA) clearance of its 510(k) application for the Bayer HER-2/neu serum test for use in the follow-up and monitoring of patients with metastatic breast cancer. The Bayer serum HER-2/neu test is the first FDA-cleared blood test for measuring circulating levels of the HER-2/neu oncoprotein.

The Role of HER-2/neu Oncoprotein in Breast Cancer

The HER-2/neu oncoprotein has been widely studied for many years and has been shown to play a pivotal role in the development and progression of breast cancer. HER-2/neu has been shown to be an indicator of poor prognosis with patients exhibiting aggressive disease, decreased overall survival and a higher probability of recurrence of disease. As evidenced by numerous published studies, elevated levels of HER-2/neu (also referred to as overexpression) are found in about 30% of women with breast cancer. Determination of a patient's HER-2/neu status may be valuable in identifying whether that patient has a more aggressive disease and would, thus, derive substantial benefit from more intensive or alternative therapy regimens. Elevated levels of HER-2/neu are found not only in breast cancer but also in several other tumor types including prostate, lung, pancreatic, colon and ovarian cancers.

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 HER-2/neu 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.

Traditional HER-2/neu testing is generally limited to tissue from primary breast cancer and does not provide information regarding the HER-2/neu status in women with recurrent, metastatic breast cancer. The introduction of HER-2/neu testing using a serum sample now offers a less invasive diagnostic tool and provides a current assessment of a woman's HER-2/neu status over the course of disease.

"This FDA clearance is an important milestone in the evolution of our oncology research and development program," according to Hans Hiller, Ph.D., Senior Vice President in the Laboratory Testing Segment of Bayer Diagnostics. "Bayer's strategy is to identify key oncoproteins and tumor markers from which to develop new tests, and to link these tests with the appropriate treatment options."

Bayer received FDA clearance for the microtiter plate ELISA product for monitoring HER-2/neu levels in metastatic breast cancer and this product is readily available throughout the United States. Microtiter plates are manual assays that can be used in any laboratory. The HER-2/neu oncoprotein test was also cleared for use on the Bayer Immuno 1(R) Immunoassay System, an automated central laboratory instrument. Earlier this year, Bayer announced FDA approval of the Bayer complexed prostate specific antigen (cPSA) assay as an aid in the detection of prostate cancer on the Bayer Immuno 1 Immunoassay System as well as FDA clearance for the cPSA microtiter plate for use in monitoring prostate cancer. Both the HER-2/neu and cPSA assays are important parts of Bayer's new and growing oncology assay portfolio.

Breast Cancer

According to the American Cancer Society, excluding cancers of the skin, breast cancer is the most common form of cancer among women, accounting for nearly one of every three cancers diagnosed in United States women. In 2000, approximately 183,000 new cases of invasive breast cancer and nearly 43,000 additional cases of in situ breast cancer will be diagnosed among women in the US Only lung cancer accounts for more cancer deaths in women.

Bayer Diagnostics

The Bayer Serum HER-2/neu oncoprotein test was developed in collaboration with Oncogene Science Inc., the assets of which Bayer acquired in December of 1999. Bayer Diagnostics' Oncogene Science group functions as a specialized center of excellence focused on clinical research and development of cancer diagnostic tests based on oncogenes, tumor supressor genes and other gene targets whose proteins are directly involved in tumor growth or metastasis. These tests are designed to aid oncologists in the confirmation, monitoring, staging, screening or prognosis of human cancer.


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Editor: Susan K. Boyer, RN
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