This aim of this Phase I SBIR proposal from Applikate Technology, LLC, is to validate the use of ClearView, a novel approach to performing complete and non-destructive imaging of tissue specimens, for primary pathology of lung biopsies. Error rates for diagnoses of lung cancer from biopsies may run as high as 15%. Although the root causes of errors are diverse, immunohistochemistry (IHC) and molecular analysis are some of the newest and most valuable tools employed for surgical pathology accuracy. Indeed, results from IHC and molecular analysis are now considered critical for determining the path of care and the appropriate agent for chemotherapy. However, their use is dependent on having enough sample tissue after initial morphologic evaluation. Applikate Technologies has developed ClearView, a proprietary approach for morphologic evaluation of biopsies without worry that tissue will be "exhausted" before IHC and molecular analysis studies. In addition, ClearView enables complete, non-destructive imaging of entire biopsy samples, improving limits of slide-based histology that include partial tissue visualization, artifacts of preparation, non-quantitative interpretation, limited growth pattern information, and extensive manual preparation.
The specific aims of the proposal are to: 1) Demonstrate primary lung cancer diagnosis on samples processed with ClearView;2) Verify the compatibility of ClearView processing with IHC and molecular analyses and 3) Develop software for automated pseudo-coloring and image normalization in order to present the pathologist with images that reliably mimic conventional staining with hematoxylin and eosin. Successful completion of these aims will set the stage for a Phase II proposal to develop a system ready for commercial deployment. Phase III will establish a specialized lung pathology service based on ClearView.
Determining the best course of treatment for lung cancer, the most common form of cancer in the United States, is increasingly dependent on the use of advanced genetic and protein analyses that require a sufficient amount of biopsy tissue for accurate results. Yet, the initial diagnosis of cancer often uses up too much of the available tissue, requiring a second biopsy procedure with the associated non-trivial patient risk and costs. This proposal seeks to validate ClearView, a novel approach for tissue processing that does not consume any tissue during the initial diagnosis and therefore maximizes the effectiveness of genetic and protein analyses.