Jan. 21st, 2009

joreth: (Nude Drawing)

A company in Australia, called Cellscreen, is currently working on a Home HPV test for women. They have undergone beta testing in Australia and are beginning the process for FDA approval in the US. The current most common method for detecting HPV infections in women in the US is the pap smear, which was developed in the 1920s and requires a tissue sample from the cervix, obtained by scraping the cervix with a spatula or brush. This is one of the most uncomfortable routine procedures women have to go through and many women avoid their annual OB/GYN visit because of the discomfort and the embarassment. 50% of cervical cancer patients have never had a pap smear. This procedure, however, has been highly effective in catching cervical cancer in stages early enough to respond to treatment. The downside is that it apparently has a 15-20% false negative rate (meaning that 15-20% of women who actually have the early stages of cervical cancer or dysplasia get a negative test result and leave without knowing they are infected), and according to this company's investor brochure (so take it with a grain of salt), some research indicates the pap smear has less than a 70% efficacy rate.

This new test, called the TamPap (short for Tampon and Papilloma), allows women to insert any brand of tampon they choose, remove it, then send it to a lab via mail, where a DNA test, which is more effective than the current pap smear test, is performed and the results sent back either by phone or mail.

"The presence of human cells on the tampon is confirmed by a beta-actin detection step. A PCR based DNA test can reliably reveal the presence of HPV and of any high risk HPV genotypes. ... HPV DNA is only prsent in small amounts. The DNA must therefore be amplified using standard DNA amplification processes to provide sufficient DNA to yield interpretable results. ... The Cellscreen screening assay uses biphasic real time polymerase chain reaction (RT-PCR) to detect the presense of human papillomavirus DNA. This RT-PCR screening utilises a variation of SPF primer sets published a decade ago and Styo9 dye to show a simple positive/negative result. The typing process can then identifh which, if any, of the fifteen high risk HPV genotypes (namely 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, and 82) and two moderate-high risk types (66 and 70) are present in a sample. This process can identify multiple HPV genotypes, if present in a single sample"

This test is designed, not to replace the pap smear, but to compliment it. The DNA test only tells the patient whether she has an HPV infection, but it does not detect the presence of cancer or lesions. If you have the ability to know that you have an active HPV infection, you can increase your watch for cancer, and if you know that you do not currently have an active HPV infection, you can decrease your watch to the suggested pap smear of every 2 years with more frequent DNA tests - providing there is a cost and time-efficient way to do that, such as this new home test provides.

The reason why this is such important news is thanks to our last president's goodbye to women. Medical practitioners are no longer required to give a pap test, or any other procedure, if it goes against their religious beliefs. As the company says in their press release, "The process also is complementary to the work of the medical practitioner who now is no longer required to perform an invasive and time consuming cervical scrape to test for HPV." The company is also designing their marketing techniques to reach those women who avoid their pap or OB/GYN visit entirely due to discomfort, or embarassment. This could significantly reduce the mortality rates (fortunately, already low in the US) of cervical cancer.

Some more information about HPV and cervical cancer:
  • In the US, 50% of women diagnosed with cervical cancer have never been screened and 10-20% have not been screened in the last 5 years. Additionally, 30% of women with cervical cancer were screened but returned a false negative result from their pap test.
  • Globally, HPV has a prevalence of around 9-13% of the total population (male and female), equating to approximately 725 million infected people. In the USA alone there are 6.2 million new cases each year, and 15-20 million American women are infected with HPV at any one time.
  • Young women in their early twenties pose the highest risk of infection. This decreases in women over thirty, but these older women tend to suffer more persistent infections and have increased chance of developing cervical cancer. A recent study has reported that women aged between 40-50 years who test positive for HPV have a greater than 20% chance of developing cervical cancer within 10 years
There are several HPV tests on the market at present with the most successful being the Digene Inc Hybrid Capture, 2-High Risk HPV DNA test, the only HPV test that has obtained USA FDA Approval, and the PapilloCheck and Amplicor tests in Europe.

The majority of the products that are in development and on the market utilize samples taken during a normal pap smear test where cells are taken from the cervix using a speculum and brush technique and the sample stored in a thin prep liquid based preserver and are only available through a medical practitioner (liquid based cytology).

Approximately 92% of the annual 60 million pap smear tests conducted in the USA today are completed using liquid based cytology. In Europe there are approximately 45-55million pap smear tests conducted annually which is expected to grow with the increasing emphasis on screening and prevention techniques.

Two self sampling HPV tests are also available ­ CerviScreen and Fournier's Feminine Multi-Test. The Digene HPV test is currently the only test approved in the USA for the detection of high risk HPV.

Other companies currently developing HPV DNA tests that are in development and expected to be released onto the market in the next two years are SensiGen, ValiRX and NorChip. Fournier's Feminine Multi-test is a self sampling test that utilizes a tampon like device to collect cells from the cervix. This test is designed to be undertaken in a supervised environment to achieve cell samples that are of a higher quality.

In comparison to other tests available in the market Cellscren's Tam Pap self sampling home based test has the following competitive advantages:·

  • The Tam Pap Test can successfully and simultaneously detect and genotype high risk strains of HPV (particularly 16 and 18) using a minimally invasive, private and painless technique, whereas other tests (including the only current FDA approved test) rely on pap smear type procedures to take cervical swabs and are more limited in the number of HPV genotypes they detect;·
  • The Tam Pap Test can also successfully detect low risk strains of HPV (including types 6 and 11) which can cause genital warts and other infections;·
  • The Tam Pap Test does not require the initiation of a pap smear to collect cells for analysis. The Tam Pap Test uses a simple tampon to collect DNA that can be 100% accurately analysed for the presence of HPV;·
  • The Tam Pap Test will be positioned in the market place for women as an affordable and cost effective test making it a practical alternative for women;·
  • The Tam Pap process can be implemented without access to a physician in areas where immediate availability is difficult to obtain;·
  • The Tam Pap process is secure and safe to use and will potentially promote increased levels of usage due to the important fact that privacy can be maintained

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