The Pap smear, named after Dr. George Papanicolaou, has been a simple and cost-effective screening tool for the early detection of cervical cancer for more than 50 years. It is in fact the single most effective screening test for detecting cancer known to medical science. Approximately 55 million Pap smears are performed each year in the U.S., and many more around the world. Its widespread use is credited with a 70% to 80% reduction in the incidence of, and mortality from, invasive cervical cancer in most developed countries.

The Pap smear has one serious drawback, however: an apparent low sensitivity, reflected by a high incidence of false negatives; i.e., the Pap test reports no abnormalities when in fact a biopsy shows pre-cancerous lesions or cancer in situ. The medical literature quantifies the incidence of false negatives from 10% to 70%, but 25% to 45% may be more realistic. While this rate is alarmingly high, the potentially devastating effects have been indirectly avoided because of the test's frequent repetition---generally every year.

This invention provides a device and method of performing a new and different type of Pap test that has the potential to avoid, or greatly minimize, false negatives in early cervical cancer. This method, to which we refer to as "Pap Imprint," offers the opportunity to harvest and map all relevant cellular populations of the cervix (cells from the endocervix, transformation zone, and ectocervix). More important, cells thus harvested would maintain their spatial and cellular interactions with one another in relation to their anatomical location in the cervix. Our Pap Imprint technology could also be used to obtain relevant information related to the pathophysiology of cervical malignant transformation, infertility, etc., by allowing special staining procedures or immunohistochemistry studies to be performed, among others.