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TEST:
OncoScreen™ Focus CDx Tissue Kit

Type:
CE Marked
Related tests:

Details

Evidence
The OncoScreen™ Focus CDx Tissue Kit is a qualitative NGS-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of mutations in 13 genes including EGFR/ALK/ROS1/RET/MET/ERBB2/BRAF/PIK3CA/KRAS/NRAS/HRAS/KIT/PDGFRA using DNA extracted from FFPE tissues in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and gastrointestinal stromal tumor (GIST). Mutations include SNV, InDel, rearrangement (fusion), and CNV.
Cancer:
Colorectal Cancer, Gastrointestinal Stromal Tumor, Non Small Cell Lung Cancer
Gene:
ALK (Anaplastic lymphoma kinase), BRAF (B-raf proto-oncogene), EGFR (Epidermal growth factor receptor), HER-2 (Human epidermal growth factor receptor 2), HRAS (Harvey rat sarcoma viral oncogene homolog), KIT (KIT proto-oncogene, receptor tyrosine kinase)
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Method:
Next-Generation Sequencing (NGS)
Approvals
Date
Cancer
Gene
Drug
By
05/07/22
CE