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 In addition to prostate cancer, Gen-Probe
is actively developing a molecular diagnostic
test for high-risk subtypes of the human
papillomavirus (HPV), which causes cervical
cancer. The Company made important
progress on this assay in 2006, and believes
early studies on its performance are promising.
In 2007, Gen-Probe plans to conduct
additional studies of its HPV assay in
preparation for an expected European
launch in 2008.
Research has shown that the higher a patient’s PCA3
score, the more likely he is to have a positive prostate
biopsy. The data above are from the CE-marked
European package insert for PROGENSA. In this
study of 529 men scheduled for a biopsy, men with
high PCA3 scores (red bars) were more likely to have
a positive biopsy than men with low PCA3 scores
(orange bars). Overall, 34% of men in this study had a
positive biopsy.
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Two key members of the Gen-Probe team working on the APTIMA
HPV assay are Dan Kolk, PhD, associate director of product development,
and Ronda Allen, PhD, program manager.
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