February 5, 2008 - CytoCore Inc. said today that the FDA 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, according to CytoCore.
"Each year, over two million American women are told that their Pap test was negative when, in fact, they have early stage cervical cancer," said CoytoCore CEO Robert McCullough, Jr. "These false negatives are frequently caused by an inadequate or incomplete sample of cervical cells. SoftPAP collects complete specimens from the cervical canal, the cervical surface and the transition zone simultaneously. There is evidence that the use of SoftPAP significantly reduces the rate of false negative Pap tests leading to earlier treatment of cervical cancer."
For more information: www.cytocoreInc.com