FDA approves claims for ThinPrep Pap test

The ThinPrep Pap test can now claim to be significantly more effective than the traditional Pap smear, following U.S. Food and Drug Administration (FDA) approval. The FDA originally had approved the ThinPrep system as an alternative for the Pap smear last May and now for the first time will allow a company to claim to be more effective than the 52-year-old Pap, says Joseph Kelly, CFO and vice president for Cytyc Corp. in Boxborough, MA, manufacturer of ThinPrep.

At the company’s request, the FDA re-examined clinical data demonstrating the new system’s effectiveness and agreed that Cytyc could claim to be better than the Pap. Those data showed that ThinPrep improved the detection of low-grade and more severe cervical cancer lesions by 65% and reduced the number of less-than-adequate specimens by more than 50%.

For a Pap test, a substantial portion of the cervical cells collected is discarded along with the collection device in the doctor’s office. What remains can be obscured by blood, mucous, and other materials. With the ThinPrep test, the physician collects a cervical cell sample using a broom-like device, but instead of "smearing" it on a slide, first rinses it in a preservative solution, capturing most of the sample. This specimen is then sent to a laboratory, where a ThinPrep instrument filters it to reduce obscuring materials and applies a thin, even layer of cells to the microscope slide.

Cytyc has trained 30 laboratories to use the ThinPrep system and began shipments of the product to doctors’ offices in the third quarter of 1996, Kelly says. The company will market ThinPrep to physicians before considering a campaign aimed at women consumers.

For more information on ThinPrep, call Cytyc Corp., 85 Swanson Road, Boxborough, MA 01719. Telephone: (800) 442-9892 or (508) 263-8000. Fax: (508) 635-1033. World Wide Web: http://www. thinprep.com.