www.fdanews.com/articles/186423-cancer-genetics-gets-510k-clearance-for-tissue-of-origin-test
Cancer Genetics Gets 510(k) Clearance for Tissue of Origin Test
April 16, 2018
Cancer Genetics received FDA clearance for its tissue of origin test after making modifications to the test reagents and software.
The microarray-based gene expression test evaluates the genomic information of tumors to identify their origin, which is used to diagnose metastatic, poorly differentiated and undifferentiated cancers.
The test covers 15 of the most common types of tumors, including thyroid, breast, non-small cell lung, pancreas, kidney, bladder and liver cancer.