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
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.