Prostate biopsy is the definitive test for the diagnosis of prostate cancer. An estimated 2 million procedures are performed annually in the United States. The current standard of care prostate biopsy when compared to surgical pathology, either underestimates or overestimates the severity of the disease up to 40% of the time, particularly in men with equivocal disease. Although significant advances have been in made in imaging, histologic analysis and genomic testing, the core biopsy needle and methods to retrieve tissue specimens have not changed in decades. Increased options to treat prostate cancer have created the need to improve the diagnostic performance of prostate biopsy to provide the patient with the appropriate treatment regimen.
The most common biopsy needle designs are prone to deflection, resulting in as much as a 50% reduction in the volume of tissue sampled.