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In the ALTS study, women with ASCUS or LSIL Pap test results and who tested positive for HPV16 in the Roche Diagnostics' HPV Line Blot test had 38 times the risk of developing CIN3 or cervical cancer within 2 years, compared to HPV-negative women in the study.
The ASCUS result persisted in 5 (3%), progressed to low-grade squamous intraepithelial lesions (LSIL) in 11 (8%), and progressed to high-grade squamous intraepithelial lesions (HSIL) in 7 (5%).
The HCT II test for high-risk HPV was performed in patients who had diagnoses of ASCUS, LSIL, or HSIL on cytologic examination.
Since TBS was published and implemented, many clinicians have felt overwhelmed with ASCUS diagnoses in their patient populations.
ASC results will probably be a somewhat smaller percentage of Pap smear results, compared with ASCUS.
We believe that HPV testing, using our Hybrid Capture(R) 2 HPV Test, can help provide women with ASCUS Pap results better, faster answers that can eliminate unnecessary anxiety as well as additional procedures.
Evan Jones, Digene's Chairman and Chief Executive Officer, commented, "HPV testing using the Digene HC2 HPV Test is increasingly becoming the standard of care in the management of patients with ASCUS Pap test results.
ALTS tracked the health of more than 3,000 women with ASCUS results at four clinical centers over a two-year period.
A complete analysis of the study data has not yet been finalized; however, early conclusions confirm findings from the National Institutes of Health-sponsored ASCUS/LSIL Triage Study that highlighted the relevance and importance of high-risk oncogenic human papillomavirus (HPV) DNA subtypes within ASCUS samples.
Earlier results from the ALTS study had confirmed the higher sensitivity of the HPV test in detecting high-grade cervical disease among all women with ASCUS Pap results.
The medical dilemma of how to treat a patient with ASCUS (atypical squamous cells of undetermined significance), or borderline Pap tests, has long been a major source of anxiety for both patients and clinicians.
Of the 60 million pap smears performed in the United States over 10% are determined to be ASCUS (Atypical Squamous Cells of Undetermined Significance) or LSIL (Low grade Squamous Intraepithelial Lesions).
In the ongoing ASCUS/LSIL Triage Study (ALTS), a $28 million project funded by the National Cancer Institute, a panel of cytopathologists agreed with original readings of ASCUS (atypical squamous cells of undetermined significance) only 50% of the time, and the majority of reinterpretations were downgraded to normal.
David Baunoch, vice president of operations at US Labs, a national anatomic pathology laboratory based in California, focused on the use of molecular methods-rather than routine Pap testing and colposcopy that are the norm-for the follow-up of abnormal Pap smear results known as ASCUS.
3%-5% of all tested cases are classified as ASCUS (Atypical Squamous Cells of Undetermined Significance) and another 3%-5% are reported as low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or cervical intraepithelial neoplasia (CIN).
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