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

Below, 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 below
cobas 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 below
cobas 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 below
cobas 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 below
cobas 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 below
FoundationOne 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 below
FoundationOne 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 below

FoundationOne 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 below
FoundationOne 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 below
FoundationOne 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 below
Oncomine 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/BLA
cobas 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:

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:

FoundationOne 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:

"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:

Non-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:

FoundationOne 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:

ONCO/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:

 

 
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