FDA News

CytoCore Launches Clinical Trials for the e2 Collector

(March 08,2007)--CytoCore, said that it has begun three “marketing confirmation” trials for the e2 Collector™ cervical cell collection device. These trials will compare the performance between the e2 Collector and the standard spatula/brush combination for 650 women with moderate to high-grade cervical lesions, and will determine patient and physician satisfaction.

These trials are intended to demonstrate the manufacturability, ease of use, and potential performance advantages of the e2 Collector. The Collector previously has received 510K approval from the FDA for “essential equivalency” to the spatula/brush.

As the first step in the Pap test, the e2 Collector is designed to provide more thorough and accurate collection of cervical cells from the entire cervix in a single step. Due to its shape and design characteristics, the e2 Collector is intended to offer greater ease of use for physicians and establishes consistency in cell collection thereby potentially reducing the number of false positive and false negative test results.

The first site for the confirmation trial is University Hospitals Case Medical Center (UHCMC) in Cleveland. Up to seven additional sites are expected to join the trial over the next four to six weeks. CytoCore expects to complete this trial within 90 days and submit the subsequent trial data to the FDA for clearance during the second quarter.

Much as the arrival of the Pap smear back in the 1960’s launched routine screenings that have profoundly reduced the number of cervical cancer deaths, CytoCore expects that the e2 Collector will similarly help women at risk in the detection of cervical pre-cancers in their earliest stages.

CytoCore hopes to have the e2 Collector recognized and adopted as a “best standard of care” for the patient cell collection procedure as the first step of the Pap test.

“We expect to sign distributors for the e2 Collector within the next quarter, both domestically and internationally” stated CytoCore’s CEO, Dr. Augusto Ocana. “My conversations with potential distribution partners indicate high levels of interest for this device and for CytoCore’s other products. With a successful conclusion of this trial and subject to FDA clearance, we anticipate sales of the e2 Collector to start in early to mid third quarter. Cytocore will soon be transitioning into a company with products in the market generating revenue. These are exciting times for our Company.”

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