Unfortunately, in man it proved toxic. This is good news for patients who often do not tolerate the available toxic chemotherapeutic agents. The FDA 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.
FDA approved the product after evaluating data from a multi-center clinical study involving the analysis of more than 31,500 Pap smear slides. 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. Copyright 1997-1998 Target Health Inc.