Medical Device Link.

For the Record

The recent article by Jose de la Torre-Bueno, Kenneth D. Bauer, and Branwyn Stewart Wagman, "A New Frontier in Pathology: Automating the Reading of Glass Slides" (IVD Technology, July/August 2001, pp. 37–48), describes a multicenter study comparing three methods of evaluating HER-2 protein expression. The methods that were tested included immunohistochemistry-stained slides read with the assistance of the Automated Cellular Imaging System (ACIS) by ChromaVision (San Juan Capistrano, CA), manual immunohistochemistry evaluation, and evaluation using fluorescent in situ hybridization (FISH) technology. The text erroneously states that results of the study were "presented at a joint meeting of FDA's Hematology and Pathology Devices Panel and Immunology Devices Panel in September 1998." The study was actually presented in December 2000 at the 23rd Annual Breast Cancer Symposium in San Antonio (TX), sponsored by the San Antonio Cancer Institute. The editors regret the error.