The FDA has granted approval to TriPath Imaging to expand labeling for its cervical cancer test.
The decision was based on two tests that showed TriPath’s use of a brush and spatula combination was “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,” said Paul Sohmer, chairman, president and CEO of TriPath.
“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 transport.”