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
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
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.
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.
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.