Where is everybody??? The stock jumped 70% and no one cares?
AutoCyte Notified That FDA Has Completed
Successful Review of Clinical Data in Prep PMA
Application
BURLINGTON, N.C., March 22 /PRNewswire/ -- AutoCyte, Inc. (Nasdaq: ACYT - news) today announced that it
received notification from the FDA that the Agency has completed a successful review of the clinical data in the PREP
premarket approval application (''PMA''). PREP is AutoCyte's liquid-based cytology sample preparation system that has been
undergoing review by the FDA for gynecologic use as a replacement for the conventional Pap smear. Dr. James B. Powell,
AutoCyte's President and Chief Executive Officer, stated ''Based on our discussions with FDA, we look forward to
expeditious completion of labeling discussions and the other final steps in the PMA review process.''
Dr. Powell went on to state, ''We are excited about proceeding with our goal of providing comprehensive cervical cancer
screening technologies to women, physicians and clinical laboratories in the US. Our organization is prepared to support
full-scale international commercialization of PREP. We appreciate the support of our investors, customers, suppliers and
employees in helping us achieve this goal.''
AutoCyte develops, manufactures and markets the only integrated automated sample preparation and image analysis system to
support cytotechnology professionals in cervical cancer screening. AutoCyte is currently pursuing regulatory approval of its
products for sale in the United States and has begun sales in several foreign countries. The Company's integrated system is
comprised of the AutoCyte PREP sample preparation system and the AutoCyte SCREEN computerized image analysis
system. AutoCyte SCREEN analyzes cervical sample microscope slides prepared by AutoCyte PREP.
Forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Investors are cautioned that statements in this press release which are not strictly historical statements
constitute forward-looking statements which involve risks and uncertainties including, without limitation, risks associated with
uncertainties regarding FDA approval, uncertainties regarding market acceptance and additional cost, risks associated with
technological change, the Company's history of operating losses and the uncertainty of future profitability, dependence on a
limited number of products, dependence on third-party reimbursement, limited marketing and sales experience, limited number
of customers and lengthy sales cycle, risks of adverse changes in general economic conditions, and in the healthcare industry
specific risks associated with competition and competitive pricing pressures, and other risks detailed in the Company's filings
with the Securities and Exchange Commission.
CONTACT: Dr. James B. Powell, President and Chief Executive Officer,
or William O. Green, Chief Financial Officer, both of AutoCyte,
Inc., 800-426-2176. |
