While the U.S. Preventative
Services Task Force has concluded PSA screening is ineffective and subjects
men to unnecessary harm, various groups already are working on technologies
that are likely to complement PSA screening, at least initially, and may offer
the potential to replace it altogether.
The most advanced is Gen-Probe
Inc.'s Progense PCA3 assay. The test is under FDA review as an aid in
determining the need for a repeat biopsy in men suspected of having prostate
cancer. The company expects FDA's Immunology Devices Panel to meet to discuss a
PMA in 1Q12.