FDA approves expanded labeling claims for SurePath Liquid-Based Pap Test.

2004 JUL 1 - (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 the use of a brush/plastic spatula combination collection device with TriPath Imaging's liquid-based cytology system.

The approval was granted based on a supplemental filing to TriPath Imaging's PreMarket Approval (PMA) of its liquid-based cytology system.

The data submitted to the FDA included results from a prospective, paired sample clinical study that demonstrated that an endocervical brush/plastic spatula combination is as effective as the currently approved broom-type collection device in transferring representative cervical material from the sampling device to the SurePath preservative fluid.

"This expanded labeling will improve TriPath Imaging's value proposition by addressing clinicians' needs and preferences in cervical cancer testing," stated Paul R. Sohmer, MD, chairman, president and chief executive officer of TriPath Imaging.

"The SurePath sample collection process clearly differentiates our liquid-based Pap test in the clinician's office. Optimized cervical sample collection is an essential step in screening for cancer of the cervix. We believe that the SurePath liquid-based Pap test sets the standard for sample collection and ...