July 2018—Cancer Genetics announced it has received special 510(k) clearance from the FDA for its Tissue of Origin test following modifications made to test reagents and software. Compared with the earlier version, the current TOO assay uses new labeling reagents and has a higher accuracy rate and a shorter workflow.
TOO is a microarray-based gene expression test that analyzes a tumor’s genomic information to help identify its origin. TOO assesses 2,000 individual genes, covering 15 of the most common tumor types (representing 58 morphologies) and 90 percent of all solid tumors. These tumors include thyroid, breast, non-small cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate.
Cancer Genetics, 201-528-9200