ROCKVILLE, Md--The FDA has approved NeoPath, Inc.’s AutoPap System, an automated diagnostic system for detection of cervical cancer, for use as a primary Pap smear screen. In a prospective, intended use clinical study comprised of more than 25,000 patient slides from five clinical laboratories, AutoPap achieved greater overall accuracy in the early diagnosis of cervical disease than current practice and reduced both false-negative and false-positive test results.
The AutoPap System utilizes proprietary technology, including two slide classification algorithms to identify those Pap smears with the highest likelihood of abnormality. As an initial screen, AutoPap identifies up to 25% of slides as normal; the remaining 75%, identified by the system as having the highest probability of containing abnormal cells, are then screened by cytotechnologists.
