A multi-center clinical trial by Guided Therapeutics (GT), a biotechnology company specializing in women’s health, found that current screening methods for cervical disease failed nearly a third of the time. The findings are similar to the results of an earlier landmark study carried out by the National Cancer Institute (NCI).
The most recent findings came from an FDA pivotal clinical trial of GT’s LightTouch Non Invasive Cervical Cancer detection device. Traditional methods for screening for cervical cancer performed poorly in the study. The human papillomavirus (HPV) test and colposcopy missed 32 percent of cancers and precancers, while biopsy samples overlooked 19 percent. A previous study by the NCI found that 35% of cases were missed, and only 26% of biopsies found significant disease.
LightTouch analyzes wavelengths of light reflected off cervical tissue to diagnose abnormalities. The non-invasive technology is able to detect chemical and structural changes at the cellular level. LightTouch does not require biopsy samples, and results are given immediately. GT has received approximately $6 million in grants from the NCI to develop the LightTouch device for the detection of cervical disease. Over 2,000 women were enrolled in the pivotal clinical trial.
Companies such as CYTYC Corporation, Matritech, MTM Laboratories AG, Grant Life Sciences, and CytoCore are working to create more accurate diagnostic screenings for cervical cancer, a disease that used to be the leading cause of cancer death for women in the United States. Cervical cancer still kills approximately 4,000 women in the U.S. each year.