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The Twisted Tale of Automated Pap Smear Screening

After a long history of failures by companies developing new Pap smear testing technologies, a small group of companies seem close to commercializing systems that could transform cytology testin by automating at least a part of the procedure. But these companies have yet to prove to potential users that their instruments save money in the long term and greatly improve quality for a test that most lab users believe already has a relatively low error rate.

In the summer of 1993 the employees at Boston-based Cytyc Corp. were flying high. In June, a Food and Drug Administration advisory panel had recommended that the agency approve the company’s new automated method of preparing Pap smear samples. They were close to what has long been the holy grail of cytology—automation of all or part of the Pap smear process.

The market opportunity looked great: Pap smears are one of the highest volume tests and the most effective method of...

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