Indica Labs Gets CE-IVD Mark for Its Halo Prostate Cancer Detection Software

Albuquerque, N.M.-based Indica Labs has received a CE-IVD mark for its Halo Prostate AI, artificial intelligence cancer screening software.

Halo Prostate AI was “trained” on more than 870,000 digital scans that included the full range of prostate cancer subtypes as well as benign tissue. The software was designed to help pathologists identify prostate cancer in core needle biopsies, which remove more tissue than a fine needle biopsy. 

The algorithm achieved sensitivity of 95 to 100 percent and specificity of 88 to 98 percent, in validation studies performed on 4,973 core needle biopsies from three independent cohorts from hospitals in Austria and Germany.

The algorithm correctly detected tumors in 26 cores in the validation study that were originally reported as tumor negative, the company said.