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FDA approves enhanced labeling for liquid-based cytology.
2003 JUN 5 - (NewsRx.com & NewsRx.net) -- TriPath Imaging, Inc., (TPTH) has received approval for expanded labeling claims from the U.S. Food and Drug Administration (FDA) to include study data showing a 64.4% (p
The enhanced labeling granted by the FDA reflects the results of a multisite "direct-to-vial" clinical trial in which the results obtained with 58,580 SurePath slides collected prospectively from 57 clinics that had converted almost 100% from conventional Pap smears were compared to an historical cohort of 58,988 conventional Pap smears.
The study was designed to reflect intended use in routine clinical and laboratory practice (a "direct to vial" study). No attempt was made to increase the yield of abnormality by isolating specific patient populations, by seeding with abnormal slides, by patient or clinic selection, or by any other mechanism. All available biopsy data were collected for both slide populations.
The results from the clinical study showed a detection rate for HSIL+ of 405/58,580 for SurePath slides as compared to 248/58,988 for conventional slides, resulting in detection rates of 0.691% and 0.420%, respectively. For these clinical sites and these study populations, this indicates a 64.4% (p
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...High Grade Squamous Intraepithelial and more...58,580 SurePath slides collected...lesions for the SurePath slides. In addition...Low Grade Squamous Intraepithelial and more...LSIL+) for SurePath slides of 3.371...
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Source: HighBeam Research, FDA approves enhanced labeling for liquid-based cytology.