College of American Pathologists

  AutoCyte PREP approved


Reprinted from August 1999 CAP TODAY

The Food and Drug Administration has approved the use of AutoCyte’s PREP System for use in primary screening for cervical cancer.

“This FDA clearance is a significant milestone, both for AutoCyte and for women’s health care,” AutoCyte president and chief executive James B. Powell, MD, said in a statement.

PREP is the second liquidbased, thin-layer slide preparation system to win FDA approval. Cytec’s ThinPrep 2000 system was the first, receiving its government approval in 1996. The thin-layer technology provides clearer slides for cervical cancer screening than traditional Pap test methods. (See “Your CPT questions” for coding information.)

AutoCyte announced earlier that it would merge with NeoPath Inc., which developed and markets the AutoPap Primary Screening System. The merger is expected to be completed within six months, pending shareholder and regulatory approval. The new company will be based in Burlington, NC.

AutoCyte and NeoPath have been conducting a joint clinical trial for the screening of PREP slides by the AutoPap system.