FDA Approves CytoCore's SoftPAP(TM) Cervical Cell Collector

A better pap smear in the works...hopefully will address less false-negatives...BD

CytoCore Inc. (OTCBB:CYOE), the biopharmaceutical research and medical device company for early detection and treatment of reproductive-tract cancers, announced that the U.S. Food and Drug Administration has approved the company's 510(k) submission to sell CytoCore's SoftPAP™ cervical cell collector. The SoftPAP collects more comprehensive and complete cervical cell specimens for Pap testing.

The Physician then removes the Soft PAP™ cervical cell collector from the cervix. The balloon is immediately placed into a liquid preservative in a vial, and detached from the handle. The cervical cells will become suspended in the liquid preservative. The liquid-suspended cells in the vial are transferred to a lab for analyses.

The largest single source of errors in Pap tests is bad sampling. It has been estimated that upwards of 50% of false-negative Pap tests collected using conventional spatula and/or brush techniques are "inadequate" collections. This is due to limitations in both the brush and spatula design and technique dependencies.