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 In this section:

                In Vitro Diagnostics

In Vitro Diagnostics

                        Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
          Nucleic Acid Based Tests


                        Blood Glucose Monitoring Devices
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          In Vitro Diagnostics
          List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)In Vitro Diagnostics List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
  
  	
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    PrintBelow, you would find a sortable and searchable table that lists all active indications.

A *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.

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). 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.

Some devices have indication for a specific group of oncology therapeutic (group labeling). Their detailed information can be found in a second table below the main one.

For a list of all FDA cleared or approved nucleic acid based tests, see Nucleic Acid Based Tests.

Please submit any questions to DICE@fda.hhs.gov.

Download a Printable Version of this Table

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)

Diagnostic Name (Manufacturer)
			Indication - Sample Type
			Drug Trade Name (Generic) NDA / BLA
			Biomarker(s)
			Biomarker(s) (Details)
			PMA / 510(k) /
			513(f)(2) / HDE (Approval / Clearance / Grant Date)*therascreen* PDGFRA RGQ PCR Kit (QIAGEN GmbH)
			Gastrointestinal Stromal Tumors (GIST) - Tissue
			AYVAKIT (Avapritinib) NDA 212608
			*PDGFRA*
			D842V mutation
			P210002 (06/29/2023)Abbott RealTime IDH1 (Abbott Molecular, Inc.)
			Acute Myeloid Leukemia - Peripheral Blood or Bone Marrow
			Tibsovo (ivosidenib) NDA 211192
			*IDH1*
			R132 mutations (R132C, R132H, R132G, R132S, and R132L)
			P170041
			(07/20/2018)Abbott RealTime IDH1 (Abbott Molecular, Inc.)
			Myelodysplastic Syndromes (MDS) - Peripheral Blood or Bone Marrow
			Tibsovo (ivosidenib) NDA 211192
			*IDH1*
			R132 mutations (R132C, R132H, R132G, R132S, and R132L)
			P170041/S007
			(10/24/2023)Abbott RealTime IDH2 (Abbott Molecular, Inc.)
			Acute Myeloid Leukemia - Peripheral Blood or Bone Marrow
			Idhifa (enasidenib) NDA 209606
			*IDH2*
			R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S, and R172W
			P170005
			(08/01/2017)Bond Oracle HER2 IHC System (Leica Biosystems)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			ERBB2 (HER2)
			HER-2 protein overexpression
			P090015
			(04/18/2012)BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.)
			Ovarian Cancer - Whole Blood
			Lynparza (olaparib) NDA 208558
			*BRCA1* and *BRCA2*
			Mutations
			P140020
			(12/19/2014)BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.)
			Breast Cancer - Whole Blood
			Lynparza (olaparib) NDA 208558
			*BRCA1* and *BRCA2*
			Mutations
			P140020/S012
			(01/12/2018)BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.)
			Breast Cancer - Whole Blood
			Talzenna (talazoparib) NDA 211651
			*BRCA1* and *BRCA2*
			Mutations
			P140020/S015
			(10/16/2018)BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.)
			Ovarian Cancer - Whole Blood
			Rubraca (rucaparib) NDA 209115
			*BRCA1* and *BRCA2*
			Mutations
			P140020/S016
			(10/16/2018)BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.)
			Pancreatic Cancer - Whole Blood
			Lynparza (olaparib) NDA 208558
			*BRCA1* and *BRCA2*
			Mutations
			P140020/S019
			(12/27/2019)BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.)
			Metastatic Castrate Resistant Prostate Cancer (mCRPC) - Whole Blood
			Lynparza (olaparib) NDA 208558
			*BRCA1* and *BRCA2*
			Mutations
			P140020/S020
			(05/19/2020)cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.)
			Melanoma - Tissue
			Zelboraf (vemurafenib) NDA 202429
			*BRAF*
			V600E
			P110020
			(08/17/2011)cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.)
			Melanoma - Tissue
			Cotellic (cobimetinib) NDA 206192 in combination with Zelboraf (vemurafenib) NDA 202429
			*BRAF*
			V600E or V600K
			P110020/S016
			(11/07/2016)cobas EGFR Mutation Test v1 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tarceva (erlotinib) NDA 021743
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120019
			(07/15/2013)cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			T790M
			P120019/S007
			(11/13/2015)cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120019/S016
			(04/18/2018)cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120019/S018
			(04/18/2018)cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue or Plasma
			Iressa (gefitinib) NDA 206995
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120019/S019
			(08/22/0218)cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue or Plasma
			Iressa (gefitinib) NDA 206995
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120019/S031
			(10/27/2020)Group Labeling, see table belowcobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue or Plasma
			Tarceva (erlotinib) NDA 021743
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120019/S031
			(10/27/2020)Group Labeling, see table belowcobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue or Plasma
			Gilotrif (afatinib) NDA 201292
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120019/S031
			(10/27/2020)Group Labeling, see table belowcobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue or Plasma
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120019/S031
			(10/27/2020)Group Labeling, see table belowcobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			T790M
			P150044
			(09/28/2016)cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Tarceva (erlotinib) NDA 021743
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P150047
			(06/01/2016)cobas EZH2 Mutation Test (Roche Molecular Systems, Inc.)
			Follicular Lymphoma Tumor - Tissue
			Tazverik (tazemetostat) NDA 213400
			*EZH2*
			Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the *EZH2* gene
			P200014
			(06/18/2020)cobas KRAS Mutation Test (Roche Molecular Systems, Inc.)
			Colorectal Cancer - Tissue
			Erbitux (cetuximab) BLA 125084
			*KRAS*
			Mutations in codons 12 and 13 of *KRAS* gene
			P140023
			(05/07/2015)cobas KRAS Mutation Test (Roche Molecular Systems, Inc.)
			Colorectal Cancer - Tissue
			Vectibix (panitumumab) BLA 125147
			*KRAS*
			Mutations in codons 12 and 13 of *KRAS* gene
			P140023
			(05/07/2015)Dako c-KIT pharmDx (Dako North America, Inc.)
			Gastrointestinal Stromal Tumors - Tissue
			Gleevec (imatinib mesylate) NDA 021588
			C-Kit
			C-Kit protein expression in CD117 antigen-expressing cells
			P040011
			(06/27/2005)Dako EGFR pharmDx Kit (Dako North America, Inc.)
			Colorectal Cancer - Tissue
			Erbitux (cetuximab) BLA 125084
			EGFR (HER1)
			EGFR (HER1) protein expression
			P030044
			(02/12/2004)Dako EGFR pharmDx Kit (Dako North America, Inc.)
			Colorectal Cancer - Tissue
			Vectibix (panitumumab) BLA 125147
			EGFR (HER1)
			EGFR (HER1) protein expression
			P030044/S002
			(09/27/2006)FerriScan (Resonance Health Analysis Services Pty Ltd)
			Non-Transfusion-Dependent Thalassemia - Tissue
			Exjade (deferasirox) NDA 021882
			Liver iron concentration imaging
			Liver iron concentration based on the proton transverse relaxation rate of MRI images
			DEN130012 / K124065
			(01/23/2013)FoundationFocus CDxBRCA Assay (Foundation Medicine, Inc.)
			Ovarian Cancer - Tissue
			Rubraca (rucaparib) NDA 209115
			*BRCA1* and *BRCA2*
			*BRCA1* and *BRCA2* alterations
			P160018
			(12/19/2016)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Gilotrif (afatinib) NDA 201292
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Iressa (gefitinib) NDA 206995
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tarceva (erlotinib) NDA 021743
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			T790M
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Alecensa (alectinib) NDA 208434
			*ALK*
			*ALK* rearrangements
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Xalkori (crizotinib) NDA 202570
			*ALK*
			*ALK* rearrangements
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Zykadia (ceritinib) NDA 211225
			*ALK*
			*ALK* rearrangements
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tafinlar (dabrafenib) NDA 202806 in combination with Mekinist (trametinib) NDA 204114
			*BRAF*
			V600E
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			*ERBB2* (*HER2*) amplification
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Breast Cancer - Tissue
			Perjeta (pertuzumab) BLA 125409
			*ERBB2* (*HER2*)
			*ERBB2* (*HER2*) amplification
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Breast Cancer - Tissue
			Kadcyla (ado-trastuzumab emtansine) BLA 125427
			*ERBB2* (*HER2*)
			*ERBB2* (*HER2*) amplification
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Colorectal Cancer - Tissue
			Erbitux (cetuximab) BLA 125084
			*KRAS*
			*KRAS* wild-type (absence of mutations in codons 12 and 13)
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Colorectal Cancer - Tissue
			Vectibix (panitumumab) BLA 125147
			*KRAS* and *NRAS*
			*KRAS* wild-type (absence of mutations in exons 2, 3, and 4) and *NRAS* wild type (absence of mutations in exons 2, 3, and 4)
			P170019
			(11/30/2017)FoundationOne CDx (Foundation Medicine, Inc.)
			Melanoma - Tissue
			Mekinist (trametinib) NDA 204114
			*BRAF*
			V600E and V600K
			P170019
			(11/30/2017)Group Labeling, See table belowFoundationOne CDx (Foundation Medicine, Inc.)
			Ovarian Cancer - Tissue
			Lynparza (olaparib) NDA 208558
			*BRCA1* and *BRCA2*
			*BRCA1* and *BRCA2* alterations
			P170019/S004
			(07/01/2019)FoundationOne CDx (Foundation Medicine, Inc.)
			Breast Cancer - Tissue
			Piqray (alpelisib) NDA 212526
			*PIK3CA*
			C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y
			P170019/S006
			(12/03/2019)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P170019/S008
			(07/01/2019)Group Labeling, See table belowFoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tabrecta (capmatinib) NDA 213591
			*MET*
			*MET* single nucleotide variants and indels that lead to *MET* exon 14 skipping
			P170019/S011
			(05/06/2020)FoundationOne CDx (Foundation Medicine, Inc.)
			Cholangiocarcinoma - Tissue
			Pemazyre (pemigatinib) NDA 213736
			*FGFR2*
			*FGFR2* fusions and select rearrangements
			P170019/S013
			(04/17/2020)FoundationOne CDx (Foundation Medicine, Inc.)
			Metastatic Castrate Resistant Prostate Cancer (mCRPC) - Tissue
			Lynparza (olaparib) NDA 208558
			Homologous recombination repair (HRR) genes
			*BRCA1*, *BRCA2*, *ATM*, *BARD1*, *BRIP1*, *CDK12*, *CHEK1*, *CHEK2*, *FANCL*, *PALB2*, *RAD51B*, *RAD51C*, *RAD51D* and *RAD54L* alterations
			P170019/S015
			(05/19/2020)FoundationOne CDx (Foundation Medicine, Inc.)
			Solid Tumors - Tissue
			Keytruda (pembrolizumab) BLA 125514
			TMB
			TMB ≥ 10 mutations per megabase
			P170019/S016
			(06/16/2020)FoundationOne CDx (Foundation Medicine, Inc.)
			Solid Tumors - Tissue
			Vitrakvi (larotrectinib) NDA 210861
			*NTRK1*, *NTRK2* and *NTRK3*
			*NTRK1*, *NTRK2* and *NTRK3* fusions
			P170019/S017
			(10/23/2020)FoundationOne CDx (Foundation Medicine, Inc.)
			Solid Tumors - Tissue
			Keytruda (pembrolizumab) BLA 125514
			MSI-High
			Microsatellite instability-High (MSI-H)
			P170019/S029
			(02/18/2022)FoundationOne CDx (Foundation Medicine, Inc.)
			Solid Tumors - Tissue
			Rozlytrek (entrectinib) NDA 212725
			NTRK1, NTRK2 and NTRK3
			NTRK1, NTRK2 and NTRK3 fusions
			P170019/S014
			(06/07/2022)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Rozlytrek (entrectinib) NDA 212725
			ROS1
			ROS1 fusions
			P170019/S014
			(06/07/2022)FoundationOne CDx (Foundation Medicine, Inc.)
			Melanoma - Tissue
			Tecentriq (atezolizumab) BLA 761034 in combination with Cotellic (cobimetinib) NDA 206192 and Zelboraf (vemurafenib) NDA 202429
			*BRAF*
			*BRAF* V600 mutations
			P170019/S030
			(01/19/2022)FoundationOne CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			BRAFTOVI (encorafenib) NDA210496 in combination with MEKTOVI (binimetinib) NDA210498
			*BRAF*
			*V600E*
			P170019/S039
			(10/11/2023)FoundationOne CDx (Foundation Medicine, Inc.)
			Solid Tumors - Tissue
			RETEVMO (selpercatinib) NDA214246
			RET
			RET fusions
			P170019/S043
			(10/06/2023)FoundationOne CDx (Foundation Medicine, Inc.)
			Breast Cancer - Tissue
			TRUQAP (capivaertib) NDA218197 in combination with FASLODEX (fulvestrant) NDA021344
			*PIK3CA*
			*AKT1/PTEN*alterations
			P170019/S048
			(11/16/2023)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Exkivity (mobocertinib) NDA 215310
			*EGFR (HER1)*
			Exon 20 insertion mutations
			P190032/S005
			(05/03/2023)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Iressa (gefitinib) NDA 206995
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P190032
			(08/26/2020)P190032/S008
			(12/19/2022)Group Labeling, See table belowFoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P190032
			(08/26/2020)P190032/S008
			(12/19/2022)Group Labeling, See table belowFoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Tarceva (erlotinib) NDA 021743
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P190032
			(08/26/2020)P190032/S008
			(12/19/2022)Group Labeling, See table belowFoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			BRAFTOVI (encorafenib) NDA210496 in combination with MEKTOVI (binimetinib) NDA210498
			*BRAF*
			V600E
			P190032/S011
			(10/11/2023)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Metastatic Castrate Resistant Prostate Cancer (mCRPC) - Plasma
			Rubraca (rucaparib) NDA 209115
			*BRCA1* and *BRCA2*
			*BRCA1* and *BRCA2* alterations
			P190032
			(08/26/2020)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Tabrecta (capmatinib) NDA 213591
			*MET*
			*MET* single nucleotide variants and indels that lead to *MET* exon 14 skipping
			P190032/S001
			(07/15/2021)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Rozlytrek (entrectinib) NDA 212725
			*ROS1*
			*ROS1 fusions*
			P190032/S004
			(12/22/2022)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Solid Tumors - Plasma
			Rozlytrek (entrectinib) NDA 212725
			*NTRK1, NTRK2,*and*NTRK3*fusions
			*NTRK1/2/3*fusions
			P190032/S004
			(12/22/2022)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Alecensa (alectinib) NDA 208434
			*ALK*
			*ALK* rearrangements
			P200006
			(10/26/2020)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Breast Cancer - Plasma
			Piqray (alpelisib) NDA 212526
			*PIK3CA*
			C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y
			P200006
			(10/26/2020)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Metastatic Castrate Resistant Prostate Cancer (mCRPC) - Plasma
			Lynparza (olaparib) NDA 208558
			*BRCA1,* *BRCA2* and *ATM*
			*BRCA1*, *BRCA2*, and *ATM* alterations
			P200006
			(10/26/2020)Guardant360 CDx (Guardant Health, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Tagrisso (osimertinib) NDA 208065
			*EGFR* (*HER1*)
			*EGFR* exon 19 deletions, *EGFR* exon 21 L858R, and T790M
			P200010
			(08/07/2020)Guardant360 CDx (Guardant Health, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Rybrevant (amivantamb) BLA 761210
			*EGFR* (*HER1*)
			*EGFR* exon 20 insertions
			P200010/S001
			(05/21/2021)Guardant360 CDx (Guardant Health, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Lumakras (sotorasib) NDA 214665
			*KRAS*
			G12C
			P200010/S002
			(05/28/2021)Guardant360 CDx (Guardant Health, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			ENHERTU (fam-trastuzumab deruxtecan-nxki) BLA 761139
			ERBB2
			ERBB2 Activating Mutations (SNVs And Exon 20 Insertions)
			P200010/S008
			(08/11/2022)Guardant360 CDx (Guardant Health, Inc.)
			Breast Cancer - Plasma
			Orserdu (elacestrant) NDA 217639
			*ESR1*
			*ESR1* missense mutations between codons 310 and 547
			P200010/S010
			(01/27/2023)HER2 CISH pharmDx Kit (Dako Denmark A/S)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			HER-2/neu (ERBB2) gene amplification
			P100024
			(11/30/2011)HER2 FISH pharmDx Kit (Dako Denmark A/S)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P040005
			(05/03/2005)HER2 FISH pharmDx Kit (Dako Denmark A/S)
			Gastric and Gastroesophageal Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P040005/S005
			(10/20/2010)HER2 FISH pharmDx Kit (Dako Denmark A/S)
			Breast Cancer - Tissue
			Perjeta (pertuzumab) BLA 125409
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P040005/S006
			(06/08/2012)HER2 FISH pharmDx Kit (Dako Denmark A/S)
			Breast Cancer - Tissue
			Kadcyla (ado-trastuzumab emtansine) BLA 125427
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P040005/S009
			(02/22/2013)HercepTest (Dako Denmark A/S)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			ERBB2 (HER2)
			HER-2 protein overexpression
			P980018
			(09/25/1998)HercepTest (Dako Denmark A/S)
			Gastric and Gastroesophageal Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			ERBB2 (HER2)
			HER-2 protein overexpression
			P980018/S010
			(10/20/2010)HercepTest (Dako Denmark A/S)
			Breast Cancer - Tissue
			Perjeta (pertuzumab) BLA 125409
			ERBB2 (HER2)
			HER-2 protein overexpression
			P980018/S015
			(06/08/2012)HercepTest (Dako Denmark A/S)
			Breast Cancer - Tissue
			Kadcyla (ado-trastuzumab emtansine) BLA 125427
			ERBB2 (HER2)
			HER-2 protein overexpression
			P980018/S016
			(02/22/2013)INFORM HER2 Dual ISH DNA Probe Cocktail (Ventana Medical Systems, Inc.)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P100027
			(06/14/2011)INFORM HER2 Dual ISH DNA Probe Cocktail (Ventana Medical Systems, Inc.)
			Breast Cancer - Tissue
			Kadcyla (ado-trastuzumab emtansine) BLA 125427
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P100027/S030
			(05/03/2019)INFORM HER-2/neu (Ventana Medical Systems, Inc.)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P940004
			(12/30/1997)InSite Her-2/neu (CB11) Monoclonal Antibody (Biogenex Laboratories, Inc.)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2 (HER2)*
			HER2protein overexpression
			P040030
			(12/22/2004)Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (Agilent Technologies)
			Breast Cancer - Tissue
			Verzenio (abemaciclib) NDA 208716
			Ki-67
			Ki-67 protein expression
			P210026
			(10/12/2021)KIT D816V Assay (ARUP Laboratories, Inc.)
			Aggressive Systemic Mastocytosis - Bone Marrow
			Gleevec (imatinib mesylate) NDA 021588
			*KIT*
			D816V
			H140006
			(12/18/2015)LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies, Inc.)
			Acute Myelogenous Leukemia - Peripheral Blood or Bone Marrow
			Rydapt (midostaurin) NDA 207997
			*FLT3*(ITD/TDK)
			ITD mutations and TKD mutations D835 and I836
			P160040
			(04/28/2017)LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies, Inc.)
			Acute Myelogenous Leukemia - Peripheral Blood or Bone Marrow
			Xospata (gilterinib) NDA 211349
			*FLT3*(ITD/TDK)
			ITD mutations and TKD mutations D835 and I836
			P160040/S002
			(11/28/2018)MRDx BCR-ABL Test (MolecularMD Corporation)
			Chronic Myeloid Leukemia - Peripheral Blood
			Tasigna (nilotinib) NDA 022068
			t(9;21) Philadelphia chromosome
			*BCR*-*ABL* fusion
			K173492
			(12/22/2017)Myriad myChoice CDx (Myriad Genetic Laboratories, Inc.)
			Ovarian Cancer - Tissue
			Lynparza (olaparib) NDA 208558
			Myriad HRD
			Deleterious or suspected deleterious mutations in *BRCA1* and *BRCA2* genes and/or positive Genomic Instability Score)
			P190014/S003
			(05/08/2020)ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (Pillar Biosciences, Inc.)
			Colorectal Cancer - Tissue
			Erbitux (cetuximab) BLA 125084
			*KRAS*
			*KRAS* wild-type (absence of mutations in codons 12 and 13)
			P200011
			(07/30/2021)ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (Pillar Biosciences, Inc.)
			Colorectal Cancer - Tissue
			Vectibix (panitumumab) BLA 125147
			*KRAS*
			*KRAS* wild-type (absence of mutations in codons 12 and 13)
			P200011
			(07/30/2021)ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (Pillar Biosciences, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			A tyrosine kinase inhibitor approved by FDA for that indication
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P200011
			(07/30/2021)Group Labeling, See table belowOncomine Dx Target Test (Life Technologies Corporation)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tafinlar (dabrafenib) NDA 202806 in combination with Mekinist (trametinib) NDA 204114
			*BRAF*
			V600E
			P160045
			(06/22/2017)Oncomine Dx Target Test (Life Technologies Corporation)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Xalkori (crizotinib) NDA 202570
			*ROS1*
			*ROS1* fusions
			P160045
			(06/22/2017)Oncomine Dx Target Test (Life Technologies Corporation)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Iressa (gefitinib) NDA 206995
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P160045
			(06/22/2017)Oncomine Dx Target Test (Life Technologies Corporation)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Gavreto (pralsetinib) NDA 213721
			*RET*
			*RET* fusions
			P160045/S019
			(09/04/2020)Oncomine Dx Target Test (Life Technologies Corporation)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Rybrevant (amivantamb) BLA 761210
			*EGFR* (*HER1*)
			Exon 20 insertion mutations
			P160045/S027
			(12/01/2021)Oncomine Dx Target Test (Life Technologies Corporation)
			Cholangiocarcinoma - Tissue
			Tibsovo (ivosidenib) NDA 211192
			IDH1
			Single nucleotide variants
			P160045/S028
			(08/25/2021)Oncomine Dx Target Test (Life Technologies Corporation)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Exkivity (mobocertinib) NDA 215310
			*EGFR* (*HER1*)
			Exon 20 insertion mutations
			P160045/S029
			(09/15/2021)Oncomine Dx Target Test (Life Technologies Corporation)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			ENHERTU (fam-trastuzumab deruxtecan-nxki) BLA 761139
			ERBB2
			ERBB2 Activating Mutations (SNVs And Exon 20 Insertions)
			P160045/S035
			(08/11/2022)Oncomine Dx Target Test (Life Technologies Corporation)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Retevmo (selpercatinib) NDA 213246
			*RET*
			*RET* fusions
			P160045/S031
			(09/21/2022)Oncomine Dx Target Test (Life Technologies Corporation)
			Medullary Thyroid Cancer (MTC) - Tissue
			Retevmo (selpercatinib) NDA 213246
			*RET*
			RET mutations (SNVs, MNVs, and deletions)
			P160045/S031
			(09/21/2022)Oncomine Dx Target Test (Life Technologies Corporation)
			Thyroid Cancer (TC) - Tissue
			Retevmo (selpercatinib) NDA 213246
			*RET*
			*RET* fusions
			P160045/S031
			(09/21/2022)PathVysion HER-2 DNA Probe Kit (Abbott Molecular Inc.)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P980024
			(12/11/1998)PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc.)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			ERBB2 (HER2)
			HER-2 protein overexpression
			P990081
			(11/28/2000)PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc.)
			Breast Cancer - Tissue
			Kadcyla (ado-trastuzumab emtansine) BLA 125427
			ERBB2 (HER2)
			HER-2 protein overexpression
			P990081/S039
			(05/03/2019)PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc.)
			Breast Cancer - Tissue
			Enhertu (fam-trastuzumab deruxtecan-nxki) BLA 761139
			ERBB2 (HER2)
			HER-2 protein overexpression
			P990081/S047
			(09/30/2022)PDGFRB FISH Assay (ARUP Laboratories, Inc.)
			Myelodysplastic Syndrome/Myeloproliferative Disease - Bone Marrow
			Gleevec (imatinib mesylate) NDA 021588
			*PDGFRB*
			*PDGFRB* gene rearrangement at 5q31~33
			H140005
			(12/18/2015)PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Keytruda (pembrolizumab) BLA 125514
			PD-L1
			PD-L1 protein expression
			P150013
			(10/02/2015)PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.)
			Cervical Cancer - Tissue
			Keytruda (pembrolizumab) BLA 125514
			PD-L1
			PD-L1 protein expression
			P150013/S009
			(06/12/2018)PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.)
			Head and Neck Squamous Cell Carcinoma (HNSCC) - Tissue
			Keytruda (pembrolizumab) BLA 125514
			PD-L1
			PD-L1 protein expression
			P150013/S014
			(06/10/2019)PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.)
			Esophageal Squamous Cell Carcinoma (ESCC) - Tissue
			Keytruda (pembrolizumab) BLA 125514
			PD-L1
			PD-L1 protein expression
			P150013/S016
			(07/30/2019)PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.)
			Triple-Negative Breast Cancer (TNBC) - Tissue
			Keytruda (pembrolizumab) BLA 125514
			PD-L1
			PD-L1 protein expression
			P150013/S020
			(11/13/2020)PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Libtayo (cemiplimab-rwlc) BLA 761097
			PD-L1
			PD-L1 protein expression [Tumor Proportion Score (TPS) ≥ 50%]
			P150013/S021
			(02/22/2021)PD-L1 IHC 28-8 pharmDx (Dako North America, Inc.)
			Non-small cell lung cancer (NSCLC) - Tissue
			Opdivo (nivolumab) BLA 125554 in combination with Yervoy (ipilimumab) BLA 125377
			PD-L1
			PD-L1 protein expression (tumor cell staining ≥1%)
			P150025/S013
			(05/15/2020)PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.)
			Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma - Tissue
			Keytruda (pembrolizumab) BLA 125514
			PD-L1
			PD-L1 protein expression
			P150013/S027
			(11/07/2023)POMC/PCSK1/LEPR CDx Panel (PreventionGenetics, LLC)
			Obesity - Blood or Saliva
			Imcivree (setmelanotide acetate) NDA 213793
			*POMC*, *PCSK1* and *LEPR*
			Variants (Pathogenic/Likely Pathogenic) and Variants of Uncertain Significance
			DEN200059
			(01/21/2022)Praxis Extended RAS Panel (Illumina, Inc.)
			Colorectal cancer - Tissue
			Vectibix (panitumumab) BLA 125147
			*KRAS* and *NRAS*
			*KRAS* wild-type (absence of mutations in exons 2, 3, and 4) and *NRAS* wild type (absence of mutations in exons 2, 3, and 4)
			P160038
			(06/29/2017)SeCore CDx HLA Sequencing System (One Lambda Inc.
			Uveal Melanoma – Whole Blood
			Kimmtrak (tebentafusp-tebn) BLA 761228
			*HLA*
			*HLA-A*02:01*
			BR220737
			(11/28/2022)SPOT-LIGHT HER2 CISH Kit (Life Technologies Corporation)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P050040
			(07/01/2008)*therascreen* EGFR RGQ PCR Kit (Qiagen Manchester, Ltd.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Gilotrif (afatinib) NDA 201292
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120022
			(07/12/2013)*therascreen* EGFR RGQ PCR Kit (Qiagen Manchester, Ltd.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Iressa (gefitinib) NDA 206995
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120022/S001
			(07/10/2015)*therascreen* EGFR RGQ PCR Kit (Qiagen Manchester, Ltd.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Gilotrif (afatinib) NDA 201292
			*EGFR* (*HER1*)
			L861Q, G719X and S7681
			P120022/S016
			(01/12/2016)*therascreen* EGFR RGQ PCR Kit (Qiagen Manchester, Ltd.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Vizimpro (dacomitinib) NDA 211288
			*EGFR* (*HER1*)
			Exon 19 deletion or exon 21 L858R substitution mutation
			P120022/S018
			(09/27/2018)*therascreen* KRAS RGQ PCR Kit (Qiagen Manchester, Ltd.)
			Colorectal Cancer - Tissue
			Vectibix (panitumumab) BLA 125147
			*KRAS*
			G12A, G12D, G12R, G12C, G12S, G12V, G13D
			P110027
			(05/23/2014)*therascreen* KRAS RGQ PCR Kit (Qiagen Manchester, Ltd.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Lumakras (sotorasib) NDA 214665
			*KRAS*
			G12C
			P110027/S012
			(05/28/2021)*therascreen* KRAS RGQ PCR Kit (Qiagen Manchester, Ltd.)
			Colorectal Cancer - Tissue
			Erbitux (cetuximab) BLA 125084
			*KRAS*
			G12A, G12D, G12R, G12C, G12S, G12V, G13D
			P110030
			(07/06/2012)*therascreen* BRAF V600E RGQ PCR Kit (QIAGEN GmbH)
			Colorectal Cancer - Tissue
			Braftovi (encorafenib) NDA 210496 in combination with Erbitux (cetuximab) BLA 125084
			*BRAF*
			V600E
			P190026
			(04/15/2020)*therascreen* FGFR RGQ RT-PCR Kit (QIAGEN Manchester Ltd.)
			Urothelial Cancer - Tissue
			Balversa (erdafitinib) NDA 212018
			*FGFR3*
			Exon 7: R248C (c.742C>T), S249C (c.746C>G); exon 10: G370C (c.1108G>T) and Y373C (c.1118A>G); and fusions (*FGFR3*-*TACC3v1* and *FGFR3*-*TACC3v3*)
			P180043
			(04/12/2019)*therascreen* PIK3CA RGQ PCR Kit (QIAGEN GmbH)
			Breast Cancer - Tissue or Plasma
			Piqray (alpelisib) NDA 212526
			*PIK3CA*
			C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y
			P190001
			(05/24/2019)P190004
			(05/24/2019)THXID BRAF Kit (bioMérieux Inc.)
			Melanoma - Tissue
			Mekinist (trametinib) NDA 204114
			*BRAF*
			V600E or V600K
			P120014
			(05/29/2013)THXID BRAF Kit (bioMérieux Inc.)
			Melanoma - Tissue
			Tafinlar (dabrafenib) NDA 202806
			*BRAF*
			V600E
			P120014
			(05/29/2013)THXID BRAF Kit (bioMérieux Inc.)
			Melanoma - Tissue
			Braftovi (encorafenib) NDA 210496 in combination with Mektovi (binimetinib) NDA 210498
			*BRAF*
			V600E or V600K
			P120014/S008
			(06/27/2018)Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Xalkori (crizotinib) NDA 202570
			ALK
			ALK protein expression
			P140025
			(06/12/2015)Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Zykadia (ceritinib) NDA 211225
			ALK
			ALK protein expression
			P140025/S005
			(05/26/2017)Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Alecensa (alectinib) NDA 208434
			ALK
			ALK protein expression
			P140025/S006
			(11/06/2017)Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Lorbrena (lorlatinib) NDA 210868
			ALK
			ALK protein expression
			P140025/S014
			(03/03/2021)Ventana FOLR1 (FOLR-2.1) RxDx Assay 
			(Ventana Medical Systems, Inc.)
			Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer - Tissue
			Elahere (mirvetuximab soravtansine-gynx) BLA 761310
			FOLR1
			FOLR1 protein expression
			P220006
			(11/14/2022)Ventana HER2 Dual ISH DNA Probe Cocktail (Ventana Medical Systems, Inc.)
			Breast Cancer - Tissue
			Herceptin (trastuzumab) BLA 103792
			*ERBB2* (*HER2*)
			*HER-2*/*neu* (*ERBB2*) gene amplification
			P190031
			(07/28/2020)Ventana MMR RxDx Panel (Ventana Medical Systems, Inc.)
			Endometrial Carcinoma (EC) - Tissue
			Jemperli (dostarlimag-gxly) NDA 761174
			deficient mismatch repair (dMMR) proteins
			MLH1, PMS2, MSH2 and MSH6
			P200019
			(04/22/2021)Ventana MMR RxDx Panel (Ventana Medical Systems, Inc.)
			Solid Tumors
			Jemperli (dostarlimag-gxly) NDA 761174
			deficient mismatch repair (dMMR) proteins
			MLH1, PMS2, MSH2 and MSH6
			P210001
			(08/17/2021)Ventana MMR RxDx Panel (Ventana Medical Systems, Inc.)
			Solid Tumors
			Keytruda (pembrolizumab) BLA 125514
			deficient mismatch repair (dMMR) proteins
			MLH1, PMS2, MSH2 and MSH6
			P210001/S001
			(03/21/2022)Ventana MMR RxDx Panel (Ventana Medical Systems, Inc.)
			Endometrial Carcinoma (EC) - Tissue
			Keytruda (pembrolizumab) BLA 125514 in combination with Lenvima (lenvatinib) NDA 206947
			proficient mismatch repair (pMMR) proteins
			MLH1, PMS2, MSH2 and MSH6
			P210001/S002
			(06/16/2022)Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.)
			Urothelial Carcinoma - Tissue
			Tecentriq (atezolizumab) BLA 761034
			PD-L1
			PD-L1 protein expression (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area)
			P160002
			(05/18/2016)Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tecentriq (atezolizumab) BLA 761034
			PD-L1
			PD-L1 protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%])
			P160002/S006
			(07/02/2018)Ventana PD-LI (SP263) Assay (Ventana Medical Systems, Inc)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Tecentriq (atezolizumab) BLA 761034
			PD-L1
			PD-L1 protein expression
			P160046/S010
			(10/15/2021)Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Xalkori (crizotinib) NDA 202570
			*ALK*
			*ALK* gene rearrangements
			P110012
			(08/26/2011)Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Alunbrig (brigatinib) NDA 208772
			*ALK*
			*ALK* gene rearrangements
			P110012/S020
			(05/22/2020)Vysis CLL FISH Probe Kit (Abbott Molecular, Inc.)
			B-cell Chronic Lymphocytic Leukemia - Peripheral Blood
			Venclexta (venetoclax) NDA 208573
			*TP53*
			Deletion chromosome 17p (17p-)
			P150041
			(04/11/2016)Abbott RealTime IDH1 (Abbott Molecular, Inc.)
			Acute Myeloid Leukemia - Peripheral Blood or Bone Marrow
			Rezlidhia (olutasidenib) NDA 215814
			*IDH1*
			R132 mutations (R132C, R132H, R132G, R132S, and R132L)
			P170041/S006
			(12/01/2022)Agilent Resolution ctDx FIRST assay (Resolution Bioscience, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			Krazati (adagrasib) NDA 216340
			KRAS
			KRAS G12C
			P210040
			(12/12/2022)*therascreen KRAS RGQ PCR Kit (Qiagen Manchester, Ltd.)*
			Colorectal Cancer - Tissue
			Erbitux (cetuximab) BLA 125084
			*KRAS*
			KRAS wild-type (absence of mutations in codons 12 and 13)
			P110027/S013
			(12/02/2022)*therascreen KRAS RGQ PCR Kit (Qiagen Manchester, Ltd.)*
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			Krazati (adagrasib) NDA 216340
			*KRAS*
			KRAS G12C
			P110027/S013
			(12/02/2022)xT CDx (Tempus Labs, Inc.)
			Colorectal Cancer (CRC) - Tissue (Matching Blood/Saliva)
			Erbitux (cetuximab) BLA 125084
			*KRAS*
			KRAS wild-type (absence of mutations in codons 12 or 13)
			P210011 (04/28/2023)xT CDx (Tempus Labs, Inc.)
			Colorectal Cancer (CRC) - Tissue (Matching Blood/Saliva)
			Vectibix (panitumumab) BLA 125147
			*KRAS* and *NRAS*
			KRAS wild-type (absence of mutations in exons 2, 3, or 4) and NRAS wild-type (absence of mutations in exons 2, 3, or 4)
			P210011 (04/28/2023)AAV5 DetectCDx (ARUP Laboratories)
			Hemophilia A Patients - Plasma
			ROCTAVIAN (valoctocogene roxaparvovec-rvox) BLA 125720
			Anti-AAV5 Antibodies
			Antibodies to the adeno-associated virus serotype 5 (AAV5) viral vector
			P190033 (06/29/2023)FoundationOne Liquid CDx (Foundation Medicine, Inc.)
			Metastatic Colorectal Cancer (mCRC) - Plasma
			BRAFTOVI (encorafenib) NDA 210496 in combination with cetuximab BLA 125084
			*BRAF*
			*BRAF V600E* alteration
			P190032/S010 (06/08/2023)LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies, Inc.)
			Acute Myelogenous Leukemia (AML) - Peripheral Blood or Bone Marrow
			VANFLYTA (quizartinib) NDA 216993
			FLT3 (ITD/TDK)
			IDT mutations and TKD mutations D835 and I836
			P160040/S011 (07/20/2023)FoundationOne CDx 
			(Foundation Medicine, Inc.)
			Prostate Cancer - Tissue
			AKEEGA (niraparib + abiraterone acetate) NDA 216793
			BRCA1 and BRCA2
			BRCA1 and BRCA2 alterations
			P170019/S042
			(08/11/2023)CRCDx RAS Mutation Detection Assay Kit (EntroGen, Inc.)
			Colorectal Cancer (CRC) - Tissue
			Vectibix (panitumumab) BLA 125147
			*KRAS* and*NRAS*
			*KRAS* wild-type biomarkers (the absence of mutations in exons 2, 3, or 4) and *NRAS* wild-type biomarkers (the absence of mutations in exons 2, 3, or 4)
			P220005 (09/29/2023)Oncomine Dx Target Test (Life Technologies Corporation)
			Anaplastic Thyroid Cancer (ATC) - Tissue
			Tafinlar (dabrafenib) NDA 202806 in combination with Mekinist (trametinib) NDA 204114
			*BRAF*
			*BRAF* V600E mutations
			P160045/S025 (09/29/2023)

Device Indication for a Specific Group of Oncology Therapeutic Products

Diagnostic Name
			(Manufacturer)
			Indication(s) - Sample Type
			PMA (Approval Date)
			Device Indication for a Specific Group of Oncology Therapeutic Products and Trade Name (Generic) – NDA/BLAcobas EGFR Mutation Test v2
			(Roche Molecular Systems, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue or Plasma
			P120019/S031
			(10/27/2020)
			Non-small cell lung cancer (tissue):

			"Identifying patients with NSCLC whose tumors have *EGFR* exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor approved by FDA for that indication"

			List of tyrosine kinase inhibitors approved by FDA for this indication:

			Tarceva (erlotinib) - NDA 021743
				Tagrisso (osimertinib) - NDA 208065
				Iressa (gefitinib) - NDA 206995
				Gilotrif (afatinib) - NDA 201292
				Vizimpro (dacomitinib) - NDA 211288Non-small cell lung cancer (plasma)

			"Identifying patients with NSCLC whose tumors have *EGFR* exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor approved by FDA for that indication"

			List of tyrosine kinase inhibitors approved by FDA for this indication:

			Tarceva (erlotinib) - NDA 021743
				Tagrisso (osimertinib) - NDA 208065
				Iressa (gefitinib) - NDA 206995FoundationOne CDx
			(Foundation Medicine, Inc.)
			Melanoma - Tissue
			P170019/S025
			(11/10/2021)
			"Identifying patients with melanoma whose tumors have BRAF V600E and are suitable for treatment with BRAF Inhibitors approved by FDA for that indication"

			List of BRAF Inhibitors approved by FDA for this indication:

			Tafinlar (dabrafenib) - NDA 202806
				Zelboraf (vemurafenib) - NDA 202429"Identifying patients with melanoma whose tumors have *BRAF* V600E and V600K and are suitable for treatment with BRAF/MEK Inhibitor Combinations approved by FDA for that indication"

			List of BRAF/MEK Inhibitor Combinations approved by FDA for this indication:

			Cotellic (cobimetinib) - NDA 206192 in combination with Zelboraf (vemurafenib) - NDA 202429
				Braftovi (encorafenib) - NDA 210496 in combination with Mektovi (Binimetinib) - NDA 210498
				Tafinlar (dabrafenib) - NDA 202806in combination with Mekinist (trametinib) - NDA 204114Non-Small Cell Lung Cancer (NSCLC) - Tissue or Plasma
			P170019/S033
			(03/16/2022)
			"Identifying patients with NSCLC whose tumors have *EGFR* exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor (TKI) approved by FDA for that indication"

			List of tyrosine kinase inhibitors approved by FDA for this indication:

			Tarceva (erlotinib) - NDA 021743
				Tagrisso (osimertinib) - NDA 208065
				Iressa (gefitinib) - NDA 206995
				Gilotrif (afatinib) - NDA 201292
				Vizimpro (dacomitinib) - NDA 211288FoundationOne Liquid CDx
			(Foundation Medicine, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Plasma
			P190032/S008
			(12/19/2022)
			Non-small cell lung cancer (plasma)

			"Identifying patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor approved by FDA for that indication"

			List of tyrosine kinase inhibitors approved by FDA for this indication:

			Tarceva (erlotinib) - NDA 021743
				Tagrisso (osimertinib) - NDA 208065
				Iressa (gefitinib) - NDA 206995ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (Pillar Biosciences, Inc.)
			Non-Small Cell Lung Cancer (NSCLC) - Tissue
			P200011
			(07/30/2021)
			Non-Small Cell Lung Cancer (tissue):

			"Identifying patients with NSCLC whose tumors have *EGFR* exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor approved by FDA for that indication"

			List of tyrosine kinase inhibitors approved by FDA for this indication:

			Tarceva (erlotinib) - NDA 021743
				Tagrisso (osimertinib) - NDA 208065
				Iressa (gefitinib) - NDA 206995
				Gilotrif (afatinib) - NDA 201292
				Vizimpro (dacomitinib) - NDA 211288

                                                                                  Content current as of:
      12/21/2023
              
              
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		 Medical DevicesIn Vitro Diagnostics

          
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