Thursday December 11, 3:44 pm Eastern Time
Company Press Release
NeoPath Advised of AutoPap Primary Screener Review by FDA Advisory Panel on January 28, 1998
REDMOND, Wash.--(BW HealthWire)--Dec. 11, 1997--NeoPath, Inc. announced that the U.S. Food and Drug Administration (FDA), advised the company today that the Hematology and Pathology
Devices Panel will meet on January 28, 1998 to review the Company's amendment to its PreMarket Approval (PMA) Supplement for the AutoPap(R) System as a Primary Screener.
''The Company has been planning for a public panel meeting, and looks forward to the opportunity to review this life saving technology,'' says Dr. Alan C. Nelson, President and Chief Executive Officer of
NeoPath, Inc. ''We believe the data submitted to the FDA demonstrate the AutoPap's effectiveness and superiority over manual screening for the early detection of cervical cancer; thereby assisting the
cytology laboratory in improving performance over current practice. When approved, the AutoPap System will be the first commercially available, fully automated primary screening device.''
This amended PMA Supplement was submitted to the FDA on August 28, 1997 and provides clinical data which document use of the AutoPap System as a primary Pap smear screener. In its proposed
intended use, the AutoPap System identifies a certain portion of slides that would not require manual review. The remaining slides would then be screened by a cytotechnologist and a diagnosis rendered.
An extensive prospective intended use clinical study, which included approximately 31,500 Pap smear slides, was conducted at five clinical laboratories in the U.S. and Canada to evaluate the performance of
the AutoPap System as a Primary Screening device. The data indicate the AutoPap System Assisted Practice was statistically superior when compared to Current Practice in identifying atypical squamous
cells of undetermined significance and worse (ASCUS+), which includes low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), and cancer; LSIL alone; and
LSIL+ which includes HSIL and cancer. Additional analyses of the data also indicate an overall improvement in specificity when compared to current practice.
NeoPath, Inc., headquartered in Redmond, Washington, creates visual intelligence technology to increase accuracy in medical testing. The company's goal is to ensure that women worldwide receive accurate
Pap smears to reduce the threat of cervical cancer. NeoPath's core expertise is in the research, development and commercialization of technologies to automate the interpretation of medical images.
Forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain
risks and uncertainties, including without limitation, regulatory approvals; the Company's limited manufacturing, marketing, customer service and support capabilities; the status of competing products; and
other risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. |
