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T98-23                         Sharon Snider:       301-827-6242
May 5, 1998                    
                               Consumer Inquiries:  800-532-4440

FDA APPROVES FIRST AUTOMATED SYSTEM FOR PRIMARY SCREENING OF PAP SMEARS

FDA today approved the AutoPap Primary Screening System -- a first of a kind automated primary screening device for evaluating Pap smear slides for signs of cervical cancer. This system has proven effective at initially identifying samples that show signs of possible abnormal cell growth.

Pap smears are the primary method for detecting cervical cancer -- which affects more than 13,000 women a year in the United States, and is responsible for 4,500 deaths. Early detection is crucial in successfully treating the disease.

Although other automated systems (including a version of this system) have been previously approved for use to rescreen Pap smears after initial evaluation has been done by human inspection, this is the first system that has been approved to be used prior to human screening.

FDA approved the product after evaluating data from a multi-center clinical study involving the analysis of more than 31,500 Pap smear slides. The approval followed the January 28, 1998 recommendation for approval by FDA's Hematology and Pathology Devices Panel.

This device is approved for use by individuals trained in Pap smear testing and is to be used only on conventionally prepared Pap smear samples. Pap smear samples that are identified as potentially problematic by this automated system's initial screening will be re-evaluated by human analysis.

The AutoPap Primary Screening System is marketed by Neopath, Inc. of Redmond, Wash.

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