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REPLACEMENT FOR 50-YEAR-OLD PAP SMEAR METHOD IS CLEARED BY FDA PDF Print E-mail
News/Features - Feature Stories
Tuesday, 29 January 2002 18:00
The ThinPrep 2000 System, which prepares the ThinPrep® Pap Test, is intended as a replacement for the 50 year old Pap smear, the most widely used cancer screening test. More than 100 million Pap tests are performed annually worldwide.

The simple change to the conventional Pap smear improves the way that cervical cells samples are prepared. In clinical trials, the ThinPrep Pap Test reduced the number of cervical samples that were compromised due to blood, mucus and inflammation. Fewer compromised Pap test samples will reduce the number of times a woman needs to repeat a Pap test, saving her the unnecessary anxiety associated with being called back to the doctor. This feature of the ThinPrep Pap Test could potentially save the healthcare system millions of dollars that are now being spent annually on unnecessary repeat tests. Additionally, the ThinPrep Pap Test’s improved method of slide preparation may decrease the number of errors currently associated with the Pap smear. Medical experts estimate that as many as one out of four cervical abnormalities may be missed using the conventional Pap smear. A decrease in the number of errors associated with the Pap smear may lead to the detection of precancerous conditions at an earlier stage when they are more easily and cost-effectively treated.

“We believe the ThinPrep Pap Test will set a new standard for women’s healthcare,” said Patrick J. Sullivan, president and chief executive officer, Cytyc Corporation. “Since 1988, there have been many efforts to improve cervical cancer screening and the conventional Pap smear. However, women continue to be plagued by inconclusive test results. Cytyc believes the most appropriate way to increase the accuracy of the Pap test is to simply improve the way the cervical cell samples are prepared.”

With the conventional Pap smear, the physician manually smears cervical cells onto a microscope slide. Recent studies have demonstrated that this manual method results in as many as 80 percent of the collected cells being discarded with the collection device.

Additionally up to 40 percent of all Pap smears are compromised by blood, mucus, and inflammation. These limitations of the Pap smear account for the majority of inaccurate Pap test results.

With the ThinPrep Test the physician collects the cervical cell sample in the traditional manner, but rather than smearing a small portion of the cervical cells onto a slide, the collection device is rinsed in a vial of preservative solution. The patient specimen is then sent to a laboratory where an instrument disperses and filters the specimen to reduce blood, mucus, and inflammation, and applies a thin, even layer of the cervical cells to a microscope slide. The result of this process is a uniform preparation of well-preserved cells ready for microscopic examination and diagnosis.

Cervical cancer is one of the most common cancers among women in the world, with approximately 450,000 cases reported annually on a worldwide basis. American Cancer Society estimates for women in the United States in 1996 include 15,700 new cases of invasive cancer and 65,000 cases of carcinoma in situ, a serious but less threatening precancerous condition, with an estimated 4,900 deaths overall. If detected in the precancerous stage, virtually all cervical cancer is curable. The treatment of cervical cancer after it reaches the invasive stage may require chemotherapy, radiation treatment, or surgery, including hysterectomy. These forms of treatment are difficult and expensive, and are often unsuccessful.

“The most important thing is for all women over the age of 18 to receive an annual Pap test, if we are to reduce cervical cancer,” said Ellen E. Sheets, M.D., assistant professor of obstetrics and gynecology at Harvard University Medical School and director of the Pap Smear Evaluation Center at Brigham & Women’s Hospital in Boston, Mass. “This type of preparation will allow healthcare providers to more accurately diagnose cervical disease.”
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