09/05/2014
Letha McGarity originally shared:
Would you do your own Pap smear at home if it only took 5 minutes to perform? Well luckily the FDA will be making a decision on the SoloPap kit within 90days. When approved, asymptomatic women will no longer need an annual pelvic exam. Women will be able to get low cost and accurate results with this at-home Pap smear kit. SoloPap™ and Cervical Cancer:
A Hidden Battle Brewing
Cervical disease is one of the easiest diseases to diagnose early and with early treatment most women are completely cured. The lack of universal PAP testing is a problem that circles the globe. According to the World Health Organization, every year approximately 500,000 new cervical diseases are diagnosed and 275,000 women die of the disease. This year in the US over 12,000 women will be diagnosed with cervical disease and 4,000 will needlessly loose their lives because of it. SoloPap is designed to be easy for women to use in the privacy of there own home. A woman can perform the procedure in less than five minutes.
The key to SoloPap's ease and accuracy of use is that the traditional doctor's speculum has been replaced with a patented cylinder. SoloPap's design can be easily inserted into the va**na without any physician assistance. The design allows for smooth, non-traumatic entry therefore making the cell collection simple. The guide head automatically positions the cervix, allowing the collection brush to retrieve the cell samples. The cell-laden collection broom is then placed in the supplied container with a few drops of fixative. The sample is now ready for mailing to a pre-determined laboratory and then you & your physician receives the result.
Physicians vs. Researchers
There is a hidden battle brewing within the medical community about the misuse of physicians’ valuable time. Three female Doctors have come together to write a compelling journal article showing how the significant amount of time physicians spend conducting pelvic exams on asymptomatic women is unjustified. "Overuse of the pelvic examination contributes to high healthcare costs without any compensatory health benefits."
Physicians use four justifications for conducting pelvic examinations, but Westhoff, et al. (2011) reveal how the justifications are no longer relevant in light of current research, advancements in technology, and new guidelines put in place to reduce harms of over screening for cervical cancer.
Why SoloPap™?
Many women in countries of the developed world are choosing to not subject themselves to the recommended annual pelvic examinations. Most often this is due to embarrassment, time constraints, lack of insurance, and the desire not to endure the discomfort involved in the current Pap screening methods. In third world countries, access to medical professionals and examination costs are the main factors as to why women do not obtain their routine Pap test.
The medical community has realized that the key to both of these problems is to increase self-sampling by women. Currently the only self-sampling kit available uses a swab or a tampon-like device to collect a sample for HPV screening. The device used for HPV self-screening is not suitable for the Pap test. The SoloPap™ kit is the only proven self-sampling device that can be used to collect a tissue sample that can be used for both Pap and HPV screening.
With the availability of the SoloPap™ kit, the medical community will be able to offer self-screening to women for HPV and Pap tests. In the developed world this translates to reduced costs and increased access to women's cervical disease screening. In third world countries these same factors will occur. The kit costs $49.
FDA approval will only take a few months
The kit utilizes all off-the-shelf components and technology. Additionally, the Pap test is not a new testing method. Rather, the company is seeking approval of a self-testing kit that has been proven in an independent third party clinical study (conducted by the U.S. Air Force) to return a cervical tissue sample equivalent to a physician-collected specimen that can be used for Pap screening. After an evaluation of the pilot study of 100 participants, it was determined that 50 more samples needed to be collected from women with Pap test abnormalities. Once that was completed, the study's statisticians determined that 150 kits proved the tissue sample derived by using the kit was equivalent to a physician-collected cervical tissue specimen suitable for the Pap test. The 510(k) application requires a 90-day response from the FDA.
H/t: +Dr Dean Kos
