theragenomics: companion tests
You find the newest and actual compilation of FDA-approved companion tests here that provide information essential for the safe and effective use of a corresponding therapeutic product in given patient subgroups, a hallmark of theragenomic medicine.
According to the FDA definition, a companion diagnostic device can be an in vitro diagnostic 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 with a particular therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.
For most current list of tests, see the page at FDA here.
Updated on December 11, 2022
| 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) |
|---|---|---|---|---|---|
| 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 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.) | Ovarian Cancer - Tissue | Rubraca (rucaparib) NDA 209115 | BRCA1 and BRCA2 | BRCA1 and BRCA2 alterations | 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.) | Cholangiocarcinoma - Tissue | Truseltiq (infigratinib) NDA 214622 | FGFR2 | FGFR2 fusions/rearrangements | P170019/S021 (05/28/2021) |
| 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.) | 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.) | 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 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) |
| 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) |
| 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) |
| 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 | Alecensa (alectinib) NDA 208434 | ALK | ALK rearrangements | P200006 (10/26/2020) |
| FoundationOne Liquid CDx (Foundation Medicine, Inc.) | Ovarian Cancer - Plasma | Rubraca (rucaparib) NDA 209115 | BRCA1 and BRCA2 | BRCA1 and BRCA2 alterations | 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) |
| 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 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) |
| 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) |
| 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 | Zejula (niraparib) NDA 208447 | Myriad HRD | Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes and/or positive Genomic Instability Score) | P190014 (10/23/2019) |
| 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 | Iressa (gefitinib) NDA 206995 | EGFR (HER1) | Exon 19 deletion or exon 21 L858R substitution mutation | P200011 (07/30/2021) |
| ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (Pillar Biosciences, Inc.) | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Gilotrif (afatinib) NDA 201292 | EGFR (HER1) | Exon 19 deletion or exon 21 L858R substitution mutation | P200011 (07/30/2021) |
| ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (Pillar Biosciences, Inc.) | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Tarceva (erlotinib) NDA 021743 | EGFR (HER1) | Exon 19 deletion or exon 21 L858R substitution mutation | P200011 (07/30/2021) |
| ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (Pillar Biosciences, Inc.) | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Vizimpro (dacomitinib) NDA 211288 | EGFR (HER1) | Exon 19 deletion or exon 21 L858R substitution mutation | P200011 (07/30/2021) |
| 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) |
| 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) |
| 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) |
| 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 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 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 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 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 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) |