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First, new scientific data continued to demonstrate that
PCA3 testing may offer advantages over traditional
prostate specific antigen (PSA) testing for some
patients. Unlike PCA3, which is over-expressed only in
malignant prostate tissue, PSA is often elevated for reasons
other than cancer. As a result, PSA testing produces
many ”false positive“ results, leading to expensive and
invasive biopsies that ultimately prove unnecessary.
Second, specialized laboratories in the United States
began purchasing Gen-Probe analyte specific reagents
(ASRs) for use in lab-developed tests for PCA3. ASRs are
the chemical building blocks of molecular tests and can
be incorporated into a lab-developed assay. Following
validation, this assay can be used for patient testing, fulfilling
a significant unmet medical need while building
physician and patient awareness.
Third, late in 2006 Gen-Probe launched its commercial
PCA3 assay in Europe. The test, called PROGENSA, is
now being offered by laboratories in Belgium, France,
Germany, the Netherlands and the United Kingdom.
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Filip Rosseel (right), associate director of international marketing,
is responsible for the launch of the PROGENSA PCA3 test in
Europe. He visits with Jan Bartel, MD, PhD, clinical pathologist at
the Labor Limbach laboratory in Heidelberg, Germany. Labor
Limbach is one of several labs across Europe offering the PROGENSA
PCA3 assay.
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