Monday May 5, 4:02 pm ET
Study Shows 64.4% Increased Detection of HSIL+ with SurePath Test Pack Versus Conventional Pap Smear
BURLINGTON, N.C., May 5 /PRNewswire-FirstCall/ -- TriPath Imaging, Inc. (Nasdaq: TPTH -News ) today announced that it 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<0.00001) increase in detection of High Grade Squamous Intraepithelial and more serious lesions (HSIL+) using the Company's liquid based cytology system, which includes the SurePath test pack and the PrepStain slide processor.
The enhanced labeling granted by the FDA reflects the results of a multi- site "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<0.00001) increase in detection of HSIL+ lesions for the SurePath slides. In addition, the study showed a detection rate for Low Grade Squamous Intraepithelial and more serious lesions (LSIL+) for SurePath slides of 3.371% as compared to a detection rate of 1.627% for conventional slides. The study also showed an Unsatisfactory slide rate of 0.222% for SurePath slides as compared to a rate of 0.534% for conventional slides. This study result is consistent with the Company's previously approved claim that its slide preparation process results in significantly fewer Unsatisfactory cases as compared to the conventional Pap smear.
Paul R. Sohmer, MD, President, CEO and Chairman of TriPath Imaging, Inc. stated, "Our labeling now reflects what our customers have told us all along. We sell a quality product at a fair price. We believe that this new claim enhances an already compelling story."