intended use study of the bd surepath plus™ pap

Conditions: Uterine Cervical Neoplasms; Uterine Cervical Cancer; Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Papilloma

Summary: this study will provide data on the performance of the bd surepath plus™ pap test for identifying high grade cervical disease. this study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive hpv test will be selected to undergo colposcopy and biopsy/ecc. subjects with abnormal cytology results with biopsy results of less than or equal to cin1 or cin2 untreated will be asked to return in 6-8 months for follow-up testing. subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).

this is a pivotal, multi-center in vitro diagnostic study comparing the bd surepath plus pap test to current practice (cytologic examination utilizing the bd surepath liquid-based pap test with conjunctive hpv testing) for the detection of cervical cancer and high-grade cervical disease (collectively referred to as cin2+) in women. the new bd surepath plus pap test combines a traditional papanicolaou staining for cellular morphology, with brown nuclear immunostaining resulting from the over-expression of specific protein biomarkers, on one slide, to improve the detection of high-grade cervical disease and cervical cancer (collectively referred to as cin2+).

Eligibility criteria:
inclusion criteria: study subjects must give voluntary written informed consent to participate in this study. - females ages 18 - 35 years, inclusive; or women at high- risk for cervical cancer or its precursor lesions. high-risk is defined as: * have had a previous high-risk hpv positive test in the last 5 years; or * have had an abnormal pap test (asc-us or higher) in the last 5 years; or * have not been screened for cervical cancer by either a pap test or hpv test in the last 5 years. exclusion criteria: * subjects who are 36 years of age or greater who are not high risk, and/or: 1. have not had an abnormal pap in the last 5 years; or 2. have not had a positive hpv test in the last 5 years; or 3. have been screened in the last 5 years without an abnormal pap or hpv result * subjects known to be pregnant or planning to become pregnant prior to the potential six months follow-up visit (self-reported). subjects who decide to become pregnant prior to the six-month follow up visit or found to be pregnant after the first visit, but prior to the six-month follow-up visit will be terminated from further study participation at that time * subjects who have had a prior complete or partial hysterectomy involving removal of the cervix. * subjects who have had an application of chemical compounds to the cervical area within the 24 hours prior to study entry, e.g., acetic acid, iodine, spermicide, douche, anti-fungal medications, etc. * subjects on whom conization, leep, laser surgery, or cryosurgery has been performed within the past five months. * subjects currently undergoing radiation and/or chemotherapy. * subjects under the age of 18. * subjects who have previously received a hpv vaccine with any number of doses.

Keywords: liquid based cytology surepath