Author Contributions: Dr Shen had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Grossman.
Acquisition of data: Grossman, Soloway, Messing, Katz, Stein, Kassabian.
Analysis and interpretation of data: Grossman, Katz, Stein, Shen.
Drafting of the manuscript: Grossman.
Critical revision of the manuscript for important intellectual content: Grossman, Soloway, Messing, Katz, Stein, Kassabian, Shen.
Statistical analysis: Shen.
Study supervision: Soloway, Messing, Katz, Stein, Kassabian.
Financial Disclosures: Dr Katz had travel expenses to a meeting reimbursed by Matritech Inc. No other authors reported disclosures.
Funding/Support: Matritech Inc supplied the experimental assay to the investigators at no cost and reimbursed clinical sites for the time involved in collection of data related to FDA submission. This included risk factors, demographic information, and test results.
Role of the Sponsor: Matritech Inc designed the study, monitored the conduct and collection of data, and reviewed the manuscript for factual accuracy and approved it.
Independent Statistical Analysis: Independent statistical analysis was performed by Dr Shen. No compensation or funding was received for conducting the analyses.
Acknowledgment: We thank statistician Heather E. Kelley, MA (West Roxbury, Mass), for analyzing the study data, Kate Bennett, BS, for data management, and the following physicians who contributed to the performance of the clinical trial: Yitzhak Berger, MD (Associates in Urology, West Orange, NJ); David Bock, MD (Kansas City Urology Care, Kansas City, Mo); Jeffrey Brady, MD (Winter Park Urology Associates, Orlando, Fla); M. Patrick Collini, MD (Urology Associates of North Texas, Fort Worth); Martin Dineen, MD (Atlantic Urological Associates, Daytona Beach, Fla); Shiva Maralani, MD (Michigan Institute of Urology, St Clair Shores); Raoul Salup, MD (James A. Haley Veterans Administration Hospital, Tampa, Fla); Kevin Tomera, MD (Alaska Clinical Research Center, Anchorage); and Alan Treiman, MD (Urology Treatment Center, Sarasota, Fla).