33,858
Participants
Start Date
August 31, 2013
Primary Completion Date
March 31, 2016
Study Completion Date
March 31, 2016
BD Onclarity™ HPV assay on BD Viper™ LT
The BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test.
Colposcopy
Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results.
Montefiore Medical Center, The Bronx
Research Pathology Associates, LLC, Irvington
Clinical Research of Philadelphia, Philadelphia
Center for Women's Health of Lansdale, Lansdale
Reading Health Physicians Network, West Reading
Research Pathology Associates, Earlysville
Tidewater Clinical, Virginia Beach
Lyndhurst Clinical Research, Winston-Salem
LabCorp, Burlington
Eastern Carolina Women's Center, New Bern
James T Martin Jr, MD, North Charleston
Fellows Research Associates - Bluffton, Bluffton
Medical Network for Education and Research, Decatur
Fellows Research Associates - Savannah, Savannah
Miami Research Associates, South Miami
Segal Institute for Clinical Research, North Miami
Comprehensive Clinical Trials, LLC, West Palm Beach
Health Awareness Inc, Jupiter
Altus, Lake Worth
University of Alabama Birmingham, Birmingham
Mobile OB/GYN, Mobile
Chattanooga Medical Research, Chattanooga
Four Rivers Clinical Research, Paducah
HWC Women's Research Center, Englewood
Indiana University, Indianapolis
Saginaw Valley Medical Research, Saginaw
Women's Health Practice, Champaign
Transgenomics, Omaha
Louisiana State University, New Orleans
Center for Disease Detection (CDD), San Antonio
Blueskies Center for Women, Colorado Springs
Physicians Research Options, Draper
Women's Health Research of Arizona, Phoenix
Quality of Life Medical & Research Center, Tucson
Visions Clinical Research, Tucson
TriCore Reference Laboratory, Albuquerque
Women's Health Care Research Corp, San Diego
West Coast Medical Research, San Diego
Vitura / Phoenix, Moorestown
Meridian Health, Neptune City
Q Squared Solutions, Teterboro
Lead Sponsor
Becton, Dickinson and Company
INDUSTRY