![]() ![]() ![]() Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 geneĬobas KRAS Mutation Test (Roche Molecular Systems, Inc.) Non-Small Cell Lung Cancer (NSCLC) - Tissue or PlasmaĬobas EZH2 Mutation Test (Roche Molecular Systems, Inc.) Non-Small Cell Lung Cancer (NSCLC) - Plasma Non-Small Cell Lung Cancer (NSCLC) - TissueĮxon 19 deletion or exon 21 L858R substitution mutationĬobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.) Metastatic Castrate Resistant Prostate Cancer (mCRPC) - Whole BloodĬobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.)Ĭotellic (cobimetinib) NDA 206192 in combination with Zelboraf (vemurafenib) NDA 202429Ĭobas EGFR Mutation Test v1 (Roche Molecular Systems, Inc.) R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S, and R172Wīond Oracle HER2 IHC System (Leica Biosystems)īRACAnalysis CDx (Myriad Genetic Laboratories, Inc.) R132 mutations (R132C, R132H, R132G, R132S, and R132L)Ībbott RealTime IDH2 (Abbott Molecular, Inc.) ![]() Please submit any questions to a Printable Version of this Table List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)ĥ13(f)(2) / HDE (Approval / Clearance / Grant Date)Ībbott RealTime IDH1 (Abbott Molecular, Inc.)Īcute Myeloid Leukemia - Peripheral Blood or Bone Marrow Their detailed information can be found in a second table below the main one.įor a list of all FDA cleared or approved nucleic acid based tests, see Nucleic Acid Based Tests. Some devices have indication for a specific group of oncology therapeutic (group labeling). In addition, the use of an IVD companion diagnostic device is stipulated in the labeling of the therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product. The use of an IVD companion diagnostic device is stipulated in the instructions for use in the labeling of the diagnostic device, either including a specific therapeutic product(s) or, if approved for oncology products, a specific group of oncology therapeutic products (for information, see the guidance for industry Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products). Below, you would find a sortable and searchable table that lists all active indications.Ī companion diagnostic device can be in vitro diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. ![]()
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