To: chirodoc who wrote (132 ) 5/31/1999 1:40:00 PM From: chirodoc Read Replies (1) | Respond to of 256
Sensitivity and Specificity Many if not most people get a little confused when they talk about sensitivity and specificity. Sensitivity is the ability of a system to detect cancer if it exists in the patient. Specificity is the percentage of diagnosis that are correct. It would be easy to develop a system that is 100% sensitive. That system would predict that every patient has cancer, but when the biopsies were done that system would be wrong most of the time. No one wants that type of system. Mammography has a sensitivity of about 80% to 85% as a stand alone screening device. That means, that if the patient has breast cancer, 80% to 85% of the time mammography will catch the cancer. Mammography's real problem is that it is wrong most of the time. Mammography is correct only about 24% of the time. For computerized thermal breast imaging it is difficult NOW to say what its sensitivity is as a stand alone screening device. The computerized thermal breast imaging system has been and is being tested as an adjunctive device to mammography intent on increasing specificity in order to reduce the number of unnecessary benign biopsies. Remember since computerized thermal imaging is a computer based system that makes its diagnosis based on data and probability parameters stored in the computer program, computerized thermal imaging's sensitivity and specificity can be adjusted. In the preliminary study conducted before the current multicenter FDA PMA trial, the computerized thermal imaging system when used as an adjunctive tool to mammography had a sensitivity of 96%, meaning that if the patient did indeed have cancer 96% of the time computerized thermal imaging detected the cancerous lesion. Also from the preliminary study computerized thermal imaging presented a correct diagnosis 52% of the time, while mammography was correct only 24% of the time. This means that with the computerized thermal imaging system being used as an adjunct to mammography, 38% of the benign biopsies could have been avoided while maintaining a sensitivity of at least 96%. Also remember that these results are from the preliminary study. Improvements have been made to the system since the preliminary study and the president of Computerized Thermal Imaging, Dave Packer, has stated in a letter to shareholders that can be read at the COII website that although they are running a blind study with the FDA, Computerized Thermal Imaging has been running a parallel study to monitor the effectiveness of the system. Dave Packer stated in the letter to shareholders that the results of the parallel study EXCEEDED their expectations. cti-net.com and cti-net.com I hope this clears up any confusion. Good luck and God bless, George