New PAP test system coming soon!!
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| Wed, 01-30-2008 - 1:52pm |
- SoftPAPâ„¢ cervical cell collector
Cocktail-CVXâ„¢ and Cocktail-GCIâ„¢ Biochemical Assays
Endometrial and Cervical Cancer Slide Based Tests
Automated Imaging Proteomic System (AIPSâ„¢)
Cervical Drug Delivery System

CytoCore's SoftPAPâ„¢ cervical cell collector offers a dramatic improvement over today's conventional collection methods for the Pap smear. Currently there are 70-80MM annual Pap tests given in the US, 100MM worldwide, and 1.5-1.8 BB women who require annual Pap testing. 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.
Conventional specimen collection is a two-step process: first using a spatula to harvest cells from the outer cervix (ecto-cervix), second using a brush to harvest cells from the less accessible cervical canal (endo-cervix). This second step is most critical in achieving an "adequate" Pap test. Failure to harvest endo-cervical cells results in an "inadequate" specimen diagnosis. Furthermore, because cervical cancer and its precursors have a tendency to begin proliferation from the endo-cervix, early detection of this highly preventable disease is predicated on identifying its presence before it reaches the ecto-cervix.
An accurate Pap test is achieved only when the brush and spatula are precisely placed and maneuvered to scrape the entire cervix including in between folds of tissue. Yet it has been reported that in an effort to minimize collection time and improve patient comfort, 30% of physicians do not use both devices, and this number may be increasing
.
The CytoCore Solutionsâ„¢ SoftPAPâ„¢ cervical cell collector offers a quicker, more accurate specimen collection with minimal possibility of user error. It is designed to consistently sample the entire cervix in a single-step using an inflatable balloon collector. The patented single-use silicon balloon is a mirror image of the surface of the ecto and endo-cervix. During collection, the balloon is slightly inflated by pressing a button on the collector handle. The volume of air is fixed and controlled so no over or under-inflation can occur. When the balloon inflates, its surface comes into contact with all walls of the entire cervix in a single-step. Cells are collected from 360 degrees around the ecto-cervix, and from within the endo-cervix. No rotation is necessary. Results include greater cellularity for analysis, reduced inadequate specimens, ease of use for the physician, and greater patient comfort.
The Physician inserts the SoftPAPâ„¢ cervical cell collector through a speculum into the cervix. The narrow tip of the SoftPAPâ„¢ cervical cell collector balloon is inserted into the cervical canal (endo-cervix), while the top of the balloon's wider base is positioned against the outer cervical area (ecto-cervix).
Pressing a button on the SoftPAPâ„¢ cervical cell collector handle automatically inflates the SoftPAPâ„¢ cervical cell collector balloon to a controlled fixed volume. The narrow tip expands the most, growing wider (not longer) pressing itself against the endo-cervical walls. The wider base of the balloon slightly expands forward pressing itself against the ecto-cervix.
Releasing the button on the handle, the SoftPAPâ„¢ cervical cell collector balloon automatically deflates, returning to its original shape. Cells from all areas of cervix adhere to the surface of the balloon through surface tension. Cells are collected from 360 degrees around the ecto-cervix, and from within the endo-cervix.
The Physician then removes the SoftPAPâ„¢ 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.
CytoCore's FDA Clinical Trial proved the SoftPAPâ„¢ cervical cell collector acquires better cell sample for more accurate pap tests. The trial yielded zero (0) false positives, and half the false negatives. Much greater density of cells was captured by the SoftPAPâ„¢ cervical cell collector resulting in fewer inadequate specimens, and enhancing the sensitivity of screening.
The SoftPAPâ„¢ cervical cell collector also reduces trauma to the cervix initiated by conventional brush and spatula scraping techniques. The collector employs a soft balloon that causes cells to adhere using controlled inflation to provide a more comfortable process for the patient while reducing incidence of post-collection bleeding or cramping. This method also reduces the number of Pap tests that get diagnosed inadequate due to obscuring blood.
Much of today's new product adoption is based on reducing the physician's liability by using the "best standard of care available" as a benchmark. The company believes that the SoftPAPâ„¢ cervical cell collector could become the "best standard of care available".
http://www.cytocoreinc.com/collector.html
Even though many young women are getting the HPV vaccine be VERY sure they are still getting their regular pap test done. The vaccines do NOT completely protect against HPV and thinking that they do can be DEADLY!
Be sure an ask your OB/GYN to use the SoftPap collector as it will be the most accurate and comfortable way to collect a sample.
Edited 1/30/2008 1:54 pm ET by doerfast
Edited 1/30/2008 2:19 pm ET by doerfast
