DOBI releases clinical data

Optical breast imaging firm DOBI Medical International of Mahwah, NJ, has released a paper compiling the results from company-sponsored research studies of its ComfortScan breast imaging system at four clinical sites over 10 months.

A total of 245 scans were acquired with prototype ComfortScan systems from March 2003 to January 2004. The scans were collected from women who had suspicious findings on their mammograms and were being further evaluated for possible breast cancer. Facilities in four countries (Italy, France, Spain, and the U.S.) participated in the studies, the company said.

Scans of 68 patients using the latest iteration of the device were read in two ways: the first in a traditional method with a physician reader, and the second with an advanced computer-assisted reading technique. The computer-assisted technique produced sensitivity of 92% and a specificity of 63% overall, close to that of the manual reading method, which produced sensitivity of 98% and a specificity of 63% for the same cohort, according to the firm.

The company said the computer-assisted technique is less operator-dependent, and requires less expertise and training than the manual method. The technique's sensitivity and specificity is expected to improve as new cases are added to refine the system's ability to identify suspicious areas.

By AuntMinnie.com staff writers
September 16, 2004

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