New Study Shows Benefits of Cytology System

A multisite "direct-to-vial” clinical trial that compared 58,580 slides collected from clinics mostly (almost 100%) using a liquid cytology system, with a historical cohort of 58,580 conventional Pap smears has found that the liquid cytology system detected 64.4% more high grade squamous intraepithelial lesions and more-serious lesions.

The trial was designed to reflect intended use in routine clinical and laboratory practice. 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. The liquid cytology system is the product of TriPath Imaging, Inc. (Burlington, NC, USA) and includes the company's SurePath test pack and the PrepStain slide processor.

In addition, the study showed a much lower rate of "unsatisfactory” slides for the TriPath system (0.222%), compared to conventional slides (0.534%). As a result of the study, the US Food and Drug Administration (FDA) has given TriPath approval for expanded labeling claims that include the new data.

"We sell a quality product at a fair price. We believe that this new claim enhances an already compelling story,” said Paul R. Sohmer, M.D., president, CEO, and chairman of TriPath Imaging.




Related Links:
TriPath Imaging