Author Contributions: As principal investigator,
Dr Grossman 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, Messing,
Acquisition of data: Grossman, Messing, Soloway,
Tomera, Katz, Berger, Shen.
Analysis and interpretation of data: Grossman,
Messing, Soloway, Shen.
Drafting of the manuscript: Grossman, Messing.
Critical revision of the manuscript for important
intellectual content: Grossman, Messing, Soloway, Tomera, Katz, Berger,
Statistical analysis: Grossman, Shen.
Obtained funding: Grossman, Messing, Soloway,
Tomera, Katz, Berger.
Administrative, technical, or material support:
Grossman, Messing, Soloway, Tomera, Katz.
Study supervision: Grossman, Messing, Soloway,
Financial Disclosures: None reported.
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 Yu Shen, PhD, at the University of Texas
M. D. Anderson Cancer Center, Department of Biostatistics and Applied Math.
Acknowledgment: We thank statistician Heather
E. Kelley, BA (West Roxbury, Mass), for her efforts analyzing the study data,
as well as the following physicians who contributed to the performance of
the clinical trial: Anthony Abner, MD (Mt. Auburn Hospital, Cambridge, Mass);
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); Vahan Kassabian, MD (Georgia Urology,
Atlanta); Shiva Maralani, MD (St Clair Shores, Mich); Raoul Salup, MD (James
A. Haley Veterans Administration Hospital, Tampa, Fla); Barry Stein, MD (Rhode
Island Hospital, Providence); Alan Treiman, MD (Urology Treatment Center,