Pap Test Device Approved by FDA
CytoCare, Incorporated received marketing clearance for their SoftPAP (pdf), a new pap smear test device. News of the approval was posted the company website in a news release. The new SoftPap system collects more cells than the conventional tools for Pap smears, which is the primary factor causing the majority of false-negative tests.
The system provides a simpler, more rapid means to collect cervical cells, as described on the CytoCare website. The design enables consistent sampling of the entire cervix in one step using the inflatable balloon catheter. The balloon is slightly inflated during collection by pressing a button on the handle of the collector. The balloon then comes into contact with the entire cervix and allows collection of cells from both the ecto- and endo-cervix.Data submitted to the FDA showed no false positives with the SoftPAP. Alternatively, the number of false negatives was about half that seen with standard pap collection systems. The sensitivity of the screening test is improved by a cell collection of broader density, lessening the likelihood of inadequate sampling.
An additional benefit of the new system are reduced side effects, data indicates that bleeding and spotting after a pap smear is reduced by 95 percent. This results from reduced trauma to the cervix with the SoftPAP design, which does not employ scraping techniques. This approach also limits the amount of blood in a specimen, which can obscure specimens and limit diagnosis.
The SoftPAP cervical cell collector was designed to reduce the incidence of false negatives during cervical cancer screening. The biggest source of errors in Pap testing is from bad sampling. Estimates suggest that more than half of the false-negative tests result from inadequate specimen collection. Problems with specimen collection result from conventional tools, both the spatula and brush, and the scraping technique employed.
February 8, 2008 Related topics: Product Approval & Certification, Laboratory Equipment, Diagnostic, Obstetrics, Gynecology & Neonatology