Cancer Genetics’ Unique Tissue of Origin Test (TOO®) Receives Special FDA 510(k) Clearance
CANCER GENETICS (CGIX)
Last cancer genetics earnings: 11/19 04:16 pm
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Source: GlobeNewswire
RUTHERFORD, N.J., April 16, 2018 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, today announced that it has received special 510(k) clearance from the U. S. Food and Drug Administration (FDA) for its Tissue of Origin test (TOO®) following modifications made to test reagents and software. TOO® is a microarray-based gene expression test that analyzes a tumor’s genomic information to help identify its origin, which is valuable in classifying metastatic, poorly differentiated, or undifferentiated cancers. TOO® assesses 2,000 individual genes, covering 15 of the most common tumor types (representing 58 morphologies) and 90% of all solid tumors [1]. 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. TOO® is the only FDA-cleared te
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