FDA approves Cytyc's ThinPrep Pap test:
This article was originally published in Clinica
Executive Summary
The US FDA has approved Cytyc's PMA supplement application for permission to include data describing the detection of high-grade squamous intraepithelial lesions (HSIL) with the firm's ThinPrep Pap cervical cancer test. The data, from a multi-site clinical outcomes trial will now be included in the Cytyc's package insert that accompanies the ThinPrep system, says the Boxborough, Massachusetts firm. The American College of Obstetricians and Gynecologists recommends that women with a cytology specimen suggesting the presence of HSIL should undergo colposcopic examination and directed biopsy, the company adds.