Neopath Announced Positive Results of Clinical Study for the AutoPap Primary Screener.

REDMOND, Wash.--(BUSINESS WIRE)--Oct. 2, 1997--NeoPath Inc. (NASDAQ: NPTH) announced today that Dr. David C. Wilbur, Associate Professor of Pathology and Laboratory Medicine at the University of Rochester Medical Center and NeoPath's Medical Director, recently presented clinical study data at the American Society of Clinical Pathology meeting.

This data was from NeoPath's recently completed clinical study which was conducted in support of the company's pending pre-market approval (PMA) supplement for use of the AutoPap System as a Primary Pap Smear Screener. The study consisted of analysis of more than 31,500 slides from 5 major laboratories across the U.S. and Canada. The study results have been submitted to U.S. Food and Drug Administration (FDA) as an amendment to the PMA supplement.

Dr. Wilbur described this study as a "prospective, two-armed masked study with cytological adjudication of slide diagnosis." As a primary screener, the AutoPap System selects approximately 25% of the cases for no further review. The remaining 75% of cases are then screened by cytotechnologists and a diagnosis is determined. The study compared the result of screening Pap smears using Current Practice versus the AutoPap System Assisted Practice. When the results between the two arms did not agree, slides were adjudicated by a three person panel of cytopathologists, to establish the final diagnosis.

Data indicated 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 clinical study data also indicated an overall improvement in specificity when compared to current practice.

Dr. Alan C. Nelson, president and chief executive officer said, "We are extremely pleased with the results of this clinical study, and believe these data indicate that NeoPath's AutoPap technology assists the cytology laboratory in improving performance over current practice for the early detection of cervical cancer; in other words, the AtuoPap System Assisted Practice reduced both the false negative rate and the false positive rate."

Unrelated to NeoPath's FDA amendment, the company has been advised by FDA that the next Hematology and Pathology Devices Advisory Panel meeting, which was tentatively scheduled for November 20 & 21, 1997, will not be convened on that date. The company recognizes the FDA's role and responsibility in setting and revising Panel meeting dates. If the FDA determines an Advisory Panel hearing is necessary to review the company's PMA Amendment, then the FDA will set a meeting date with sufficient advance notice for the company to respond.

NeoPath Inc., headquartered in Redmond, Wash., 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. -0-

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.

CONTACT: NeoPath Inc.

Stacie D. Byars, 425/556-3050

http://www.neopath.com