Large Cervical Screening Program Begins in China

A large-scale clinical trial evaluating methods of cervical cancer screening and involving 9,000 women has now begun and is expected to be completed by the middle of 2001. The study is called the Shanxi Province Cervical Screening Study (SPOCCS).

The objective of the study is to compare the sensitivity and specificity of the InPath System of cervical screening (Ampersand Medical, Chicago, IL, USA) with the standard Pap test for screening high-grade cervical dysplasia and cervical cancer. Another objective is to compare the InPath System's human papillomavirus marker to the Hybrid Capture II test of Digene (Silver Spring, MD, USA) in terms of sensitivity and specificity. The trial will also include an evaluation of the efficiency and reliability of a new collector system that a patient can use to collect her own cervical cell sample.

A presentation on the InPath System was given at the International Academy of Cytology, in Prague (Czech Republic), by Dr. Arthur Herbst, professor and chairman of the department of obstetrics and gynecology at the University of Chicago (IL, USA). Dr. Herbst said the InPath System appears to be a more accurate and less expensive process than the Pap test. He presented data showing that on a per-slide basis, the InPath System found 100% of the most serious abnormalities and was 77% accurate in identifying normal slides. No false positives were identified, and 88% of all abnormalities were found.

"Cervical cancer is a prevalent cause of death of women in developing countries,” noted Peter Gombrich, chairman and CEO of Ampersand Medical. "Through this trial in China, we intend to prove that our technology has the potential to save the lives of thousands of women around the globe.”




Related Links:
Ampersand Medical
Digene