IVD Technology Magazine
IVDT Article Index

Originally published March, 1998

IVD Technology News

AutoPap headed for primary use approval

Neopath, Inc. (Redmond, WA), and its AutoPap system have been given a boost by FDA's hematology and pathology devices advisory panel. At the end of January, the panel unanimously recommended that the agency approve the company's premarket approval (PMA) supplement for use of the device as a primary Pap smear screener.

Initial Pap smears are currently analyzed manually by cytotechnologists. Manual cytology analysis, however, can often be subjective and tedious.

An automated system could obviate interpretive error and greatly increase the capacity of clinical laboratories to test for cervical cancer. Using visual intelligence technology, the AutoPap can automatically rule out 25% of samples that have low probability of abnormality. A ranking of abnormality risk is given to the other 75%, which are then rescreened manually.

According to a Neopath press release, FDA is "committed to providing the company with a decision letter on its PMA as soon as possible."—G.W.