Education

Education

Applications

Tests

As of September 2016

Click on the "+" icons below to view tables with information on selected personalized medicine tests.

  • CARDIOVASCULAR

      • * Indicates a drug on which more information is available in the "Therapies" section of this site

      Test/Kit
      		Drug Name
      (Brand Name)
      		Indication
      AlloMap Molecular Expression Testing

      		Heart Transplant: Aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment.
      Corus ® CAD

      		 Obstructive Coronary Artery Disease: Gene expression test is a decision-making tool that can help identify patients unlikely to have obstructive CAD and help determine appropriate next steps. 
      Familion ® 5-gene profile 

      		CV: Guides prevention and drug selection for patients with inherited cardiac channelopathies such as Long QT Syndrome (LQTS), which can lead to cardiac rhythm abnormalities. 
      SINM PhyzioType TM
      		 Statins *
      		 CV: Predicts risk of statin-induced neuro-myopathy, based on a patient’s combinatorial genotype for 50 genes. 
      eQ-PCR LC Warfarin Genotyping kit
      		Warfarin * (Coumadin ®) 
      		Genotyping single nucleotide polymorphisms (SNPs) in the cytochrome P450 enzyme gene CYP2C9 known as CYP2C9*2 (C430T), CYP2C9*3 (A1075C), and a SNP in the vitamin K epoxide reductase complex 1 gene (VKORC1) known as VKORC1 (-1639G>A). 
      eSensor Warfarin Sensitivity Test
      		 Warfarin * (Coumadin ®)
      		Detection and genotyping of CYP450 2C9 (*2 and *3) and VKORC1 (-1639G>A). 
      Gentris Rapid Genotyping Assay - CYP2C9 & VKORCI
      		 Warfarin * (Coumadin ®)
      		Intended to detect the presence of CYP2C9 *2 and *3 and VKORC1 1173 C>T alleles. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients with greater risk for warfarin sensitivity. 
      INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin
      		Warfarin * (Coumadin ®) 
      		Identify CYP450 2C9 and VKORC1 genetic variants. 
      PGx PredictTM Warfarin * (Coumadin ®)
      		CV: Determines CYP2C9 and VKORC1 genotypes to predict likelihood of adverse events with warfarin therapy. 
      Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System
      		Warfarin * (Coumadin ®)
      		 The two most common alleles of CYP2C9 that affect warfarin metabolism are CYP2C9*2 (also known as R144C) and CYP2C9*3 (also known as I359L). The VKORC1 gene, located on the short arm of human chromosome 16 (16p11.2), encodes the VKORC1 protein which plays an essential role in gamma-carboxylation of Vitamin K-dependent blood clotting factors.
  • DRUG METABOLISM

      • * Indicates a drug on which more information is available in the "Therapies" section of this site

      Test/Kit
      		Drug Name
      (Brand Name)
      		Indication
      AmpliChip CYP450 microarray 

      		Detection of gene variations — including deletions and duplications — for the CYP2D6 and CYP2C19 genes, the expressed enzymes play a major role in the metabolism of an estimated 25% of all prescription drugs.
      INFINITI CYP2C19 Assay
      		Determining therapeutic strategy for therapeutics that are metabolized by the CYP450 2C19 gene product, specifically *2, *3, *17.
      Verigene CYP2C19 Nucleic Acid Test
      		Identifies a patient’s CYP2C19 *2, *3 and *17 genotype.
      xTAG ® CYP2D6 Kit
      		Determine therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product.
  • GENETIC DISEASE

      • * Indicates a drug on which more information is available in the "Therapies" section of this site

      Test/Kit
      		Drug Name
      (Brand Name)
      		Indication
      AneuVysion

      		Detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13q14 region and the 21q22.13 to 21q22.2 region.
      CEP 8 Spectrumor- ange DNA Probe Kit
      		Detect AT rich alpha satellite sequences in the centromere region of chromosome 8 in conjunction with routine diagnostic cytogenetic testing.
      eSensor ® CF Genotyping Test
      		Cystic Fibrosis: Provide patients with accurate genetic carrier screening results. Panel includes 23 ACOG/ACMG recommended mutations.
      xTAG Cystic Fibrosis 39 Kit

      v2 xTAG Cystic Fibrosis 60 Kit v2
      		Cystic Fibrosis: Test for the most prevalent CFTR gene mutations in a variety of populations. Tests a patient for only the 23 CFTR mutations recommended by the ACMG/ACOG or to also test for an additional 16 (with the xTAG Cystic Fibrosis (CFTR) 39 kit v2) or an additional 37 (with the xTAG Cystic Fibrosis (CFTR) 60 kit v2) of the world’s most common and North American-prevalent mutations.
      Verigene ® CFTR
      and
      Verigene ® CFTR PolyT Nucleic Acid Tests
      		Cystic Fibrosis: Panel includes mutations and variants recommended by the 2004 American College of Medical Genetics (ACMG) and the 2005 American College of Obstetricians and Gynecologists (ACOG). It provides information intended to be used for carrier testing in adults of reproductive age and in confirmatory diagnostic testing of newborns and children.
      InPlex CF Molecular Test
      		Cystic Fibrosis: Tests for twenty-three separate mutations in the Cystic Fibrosis Transmembrane Receptor (CFTR) gene. In addition, the IVS8-5T/7T/9T markers are automatically reflexed as part of the test. All mutations contained in the assay are recommended for testing by the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics (ACMG).
      Cystic Fibrosis Genotyping Assay
      		Cystic Fibrosis: Genotype a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human whole blood specimens. The panel includes mutations and variants recommended by the American College of Medical Genetics (ACMG, 2004) and the American College of Obstetri- cians and Gynecologists (ACOG, 2005), plus additional multiethnic muta- tions and variants. It provides information intended to be used for carrier screening in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. 
  • HEMATOLOGY

      • * Indicates a drug on which more information is available in the "Therapies" section of this site

      Test/Kit
      		Drug Name
      (Brand Name)
      		Indication
      CEP X SpectrumO- range/ Y SpectrumGreen DNA Probe Kit
      		Indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosomes X and Y in interphase nuclei and metaphase spreads obtained from bone marrow specimens in subjects who received opposite-sex bone marrow transplantation for chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), myeloproliferative disorder (MPD), myelodysplastic syndrome (MDS), acute and lymphoid leukemia (ALL), or hematological disorder not otherwise specified (HDNOS).
      eSensor Thrombophilia Risk Test
      		All four thrombophilia-related genetic markers: FV, FII, MTHFR 677, MTHFR 1298.
      Factor II (Prothrombin) G20210A Kit
      		Detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene from DNA isolated from human whole peripheral blood. Detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
      Factor V leiden Kit
      		Detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation. Detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
      Illumina VeraCode Genotyping Test for Factor V and Factor II
      		Detection and genotyping of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A point mutations in DNA obtained from EDTA-anticoagulated human blood samples. It is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
      INFINITI System
      		Identify genetic variants for Factor II, Factor V, and MTHFR genes.
      Invader Factor V
      		Detect a single nucleotide substitution mutation, causing a change in the translated protein’s amino acid at 506th position from Arginine to Glutamine.
      Invader Factor II
      		Detect G20210A mutation that is characterized by a guanine to adenine transition at position 20210 in the 3’ untranslated region of the Factor II gene.
      Invader MTHFR 677
      		Detect a polymorphism at the 677 position of the gene that causes a Cytosine to Thymine substitution.
      Invader MTHFR 1298 
      		 
      		 Detect a polymorphism at the 1298 position of the gene that causes an Adenine to Cytosine substitution.
      Verigene F5 Nucleic Acid Test Verigene F2 Nucleic Acid Test Verigene MTHFR Nucleic Acid Test
      		Detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia. Verigene F2 :(G to A at position 20210) of the human Factor II gene (F2; prothrombin gene), Verigene MTHFR: (C to T at position 677) of the human 5,10 methylene-tetra-hydro-folate reduc- tase gene (MTHFR).
      Xpert HemosIL FII & FV
      		Detection of Factor II (FII) and Factor V (FV) alleles. Performed on the Cepheid GeneXpert System, the test is intended to provide rapid results for FII (G20210A) and FV Leiden (G1691A) mutations as an aid in the diagnosis of suspected thrombophilia.
  • IMMUNOLOGY

      • * Indicates a drug on which more information is available in the "Therapies" section of this site

      Test/Kit
      		Drug Name
      (Brand Name)
      		Indication
      AlloMap ® gene signature
      		Heart transplantation: Monitors patient’s immune response to heart transplant to guide immunosuppressive therapy.
      Prometheus ® IBD Serology 7
      		 Budesonide (Entocort ®)
      		 Inflammatory bowel disease: Identifies subset of patients who will benefit from budesonide.
      ImmuKnow ®
      		Post-Transplant Immune Status: Is an immune cell function assay that detects cell-mediated immunity in an immunosuppressed population.
  • ONCOLOGY

      • * Indicates a drug on which more information is available in the "Therapies" section of this site

      Test/Kit
      		Drug Name
      (Brand Name)
      		Indication
      therascreen EGFR RGQ PCR Kit                 
      		Afatinib * (Gilotrif ®)
      		 Lung cancer: Detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) tumor tissue. It is intended to be used to select patients with NSCLC for whom Afatinib is indicated.
      CancerTYPE ID ®

      		 Classifies 28 main tumor types and 50 subtypes.
      ResponseDx: LungTM
      		Carboplatin * (Daraplatin ®)
      		 Lung cancer: Expression profiles and mutations in ERCC1, TS, EGFR, RRM1, KRAS, and EML4-ALK provide information for the selection of various therapies.
      CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe

      		 B-cell chronic lymphocytic leukemia: Detect AT rich alpha satellite sequences in the centromere region of chromosome 12 in conjunction with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosome 12 via fluorescence in situ hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with B-cell chronic lymphocytic leukemia (CLL).
      therascreen KRAS RGQ PCR Kit
      		Cetuximab * (Erbutix ®)
      		 Colorectal cancer: Detection of seven somatic mutations in the human KRAS oncogene in colorectal cancer (CRC) tissue. It is intended to aid in the identification of CRC patients for treatment with Cetuximab based on a KRAS no mutation detected test result.
      ResponseDx: ColonTM
      		Cetuximab * (Erbutix ®) 
      		 Colon cancer: Expression profiles and mutations in ERCC1, TS, EGFR, BRAF, KRAS provide information for the selection of various therapies.
      Target GI TM
      		Cetuximab * (Erbutix ®)
      		 Colon cancer: Provides information of the expression of key molecular targets—KRAS, TS, and TOPO1—to guide therapy.
      DAKO EGFR PharmDx Kit
      		Cetuximab * (Erbutix ®)
      		Colorectal cancer: Identify EGFR expression in normal and neoplastic tissue. It detects the EGFR (HER1) protein in EGFR-expressing cells. It is indicated as an aid in identifying colorectal cancer patients eligible for treatment with Cetuximab.
      ResponseDx: LungTM
      		Cetuximab * (Erbutix ®)
      		 Lung cancer: Expression profiles and mutations in ERCC1, TS, EGFR, RRM1, KRAS, and EML4-ALK provide information for the selection of various therapies.
      CompanDx ® 31-gene signature

      		 Breast cancer: The test predicts “time to event” for metastasis of breast cancer, following surgery or biopsy.
      Vysis ALK Break Apart FISH Probe Kit
      		Crizotinib * (Xalkori ®)
      		 Lung cancer: To detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH), in non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with Crizotinib.
      CupPrint TM

      		 Multiple cancers: Determines cancer classification for tumors of unknown primary origin.
      THxID TM BRAF Kit
      		Dabrafenib * (Tafinlar ®)
      		 Melanoma: Qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with Dabrafenib.
      Dako TOP2A FISH PharmDx Kit

      		 Breast cancer: Detect amplifications and deletions of the TOP2A gene in human breast cancer tissue. Deletions and amplifications of the TOP2A gene serve as a marker for poor prognosis in high risk breast cancer patients.
      ResponseDx: Lung TM
      		Erlotinib * (Tarceva ®)
      		 Lung cancer: Expression profiles and mutations in ERCC1, TS, EGFR, RRM1, KRAS, and EML4-ALK provide information for the selection of various therapies.
      Cobas EGFR Mutation Test
      		Erlotinib * (Tarceva ®)
      		 Lung cancer: Qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in human non-small cell lung cancer (NSCLC) tumor tissue. It is intended to be used as an aid in selecting patients with metastatic NSCLC for Erlotinib use.
      ResponseDx: Colon TM
      		5-FU * (Adrucil ®)
      		 Colon cancer: Expression profiles and mutations in ERCC1, TS, EGFR, BRAF, KRAS provide information for the selection of various therapies.
      ResponseDx: Lung TM
      		5-FU * (Adrucil ®)
      		 Lung cancer: Expression profiles and mutations in ERCC1, TS, EGFR, RRM1, KRAS, and EML4-ALK provide information for the selection of various therapies.
      ResponseDx: Gastric TM
      		5-FU * (Adrucil ®)
      		 Stomach cancer: Expression profiles and mutations in ERCC1, TS, and HER2 provide information for the selection of various therapies.
      ResponseDx: Lung TM
      		Gefitinib * (Iressa ®)
      		 Lung cancer: Expression profiles and mutations in ERCC1, TS, EGFR, RRM1, KRAS, and EML4-ALK provide information for the selection of various therapies.
      ResponseDx: Colon TM
      		 Gemcitabine * (Gemzar ®)
      		 Colon cancer: Expression profiles and mutations in ERCC1, TS, EGFR, BRAF, KRAS provide information for the selection of various therapies.
      ResponseDx:Lung TM
      		Gemcitabine * (Gemzar ®)
      		 Lung cancer: Expression profiles and mutations in ERCC1, TS, EGFR, RRM1, KRAS, and EML4-ALK provide information for the selection of various therapies.
      GeneSearch Breast Lymph Node (BLN) Test

      		 Breast Cancer: First intra-operative and gene-based test approved for use in the US to detect the spread of breast cancer into the lymph nodes.
      DAKO C-KIT PharmDx
      		Imatinib mesylate * (Gleevec ®)
      		 GIST: Specifically detect the c-kit protein in CD 117 antigen-expressing cells. It is indicated as an aid in the differential diagnosis of gastroin- testinal stromal tumors (GIST) for those patients eligible for treatment with Imatinib mesylate.
      Target GI TM
      		Irinotecan * (Camptosar ®)
      		 Colon cancer: Provides information of the expression of key molecular targets—KRAS, TS, and TOPO1—to guide therapy.
      ResponseDx: Colon TM
      		Irinotecan * (Camptosar ®)
      		 Colon cancer: Expression profiles and mutations in ERCC1, TS, EGFR, BRAF, KRAS provide information for the selection of various therapies.
      Invader ® UGT1A1 Molecular Assay
      		Irinotecan * (Camptosar ®)
      		 Determines the UGT1A1 *28 genotype as recommended in the label for the chemotherapeutic drug irinotecan, which is approved as a first-line therapy for metastatic colorectal cancer. Patients with a heterozygous-deficient *1 / *28 genotype or homozygous-deficient *28 / *28 genotype have greater risk for severe toxicity when treated with irinotecan therapy.
      MammaPrint

      		 Breast cancer: First and only FDA-cleared IVDMIA breast cancer recurrence assay. The unique 70-gene signature of MammaPrint provides you with the unprecedented ability to identify which early-stage breast cancer patients are at risk of distant recurrence following surgery, independent of Estrogen Receptor status and any prior treatment.
      Mammostrat ®

      		 Breast cancer: Test used for postmenopausal, node negative, estrogen receptor expressing breast cancer patients who will receive hormonal therapy and are considering adjuvant chemotherapy.
      NADiA ProsVue

      		 Prostate Cancer: The NADiA ProsVue assay is performed for patients having less than 0.1 ng/mL serum tPSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy. It is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy.
      Oncotype DX ® 16-gene signature

      		 Breast cancer: A 16-gene signature (plus five reference genes) indicates whether a patient has a low, intermediate, or high risk of having a tumor return within 10 years. Low-risk patients may be treated successfully with hormone therapy alone. High-risk patients may require more aggressive treatment with chemotherapy.
      Oncotype DX ® 7-gene signature

      		 Colon cancer: The seven-gene signature (plus five reference genes) provides a risk score that indicates whether a patient is likely to have a tumor recurrence with stage II colon cancer. Risk levels guide treatment with adjuvant chemotherapy.
      DAKO EGFR PharmDx Kit
      		Panitumumab * (Vectibix ®)
      		 Colorectal cancer: Identify EGFR expression in normal and neoplastic tissues and detects the EGFR (HER1) protein in EGFR-expressing cells. It is indicated as an aid in identifying colorectal cancer patients eligible for treatment with Panitumumab.
      ResponseDx: Colon TM
      		Panitumumab * (Vectibix ®)
      		 Colon cancer: Expression profiles and mutations in ERCC1, TS, EGFR, BRAF, KRAS provide information for the selection of various therapies.
      Target GI TM
      		Panitumumab * (Vectibix ®)
      		 Colon cancer: Provides information of the expression of key molecular targets—KRAS, TS, and TOPO1—to guide therapy.
      ResponseDx: Lung TM
      		Panitumumab * (Vectibix ®)
      		 Lung cancer: Expression profiles and mutations in ERCC1, TS, EGFR, RRM1, KRAS, and EML4-ALK provide information for the selection of various therapies.
      Pathwork Tissue of Origin Test Kit— FFPE

      		 Measure the degree of similarity between the RNA expression patterns in a patient’s tumor and the RNA expression patterns in a database of fifteen tumor types (poorly differentiated, undifferentiated and metastatic cases) that were diagnosed according to then current clinical and pathological practice.
      ResponseDx: Colon TM
      		Pemetrexed * (Alimta ®)
      		 Colon cancer: Expression profiles and mutations in ERCC1, TS, EGFR, BRAF, KRAS provide information for the selection of various therapies. 
      HERCEPTESTPertuzumab * (Perjeta ®)
      		 Breast cancer: To determine HER2 protein overexpression in breast cancer tissues from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. It is indicated as an aid in the assessment of breast cancer patients for whom Pertuzumab treatment is being considered.
      HER2 FISH PharmDx Kit
      		Pertuzumab * (Perjeta ®)
      		 Breast cancer: Quantitatively determine HER2 gene amplification in breast cancer tissue and patients with metastatic gastric or gastroesophageal junction adenocarcinoma. It is indicated as an aid in the assessment of breast cancer patients for whom Pertuzumab is being considered.
      MLH1, MSH2, MSH6

      		Multiple cancers: Guides surveillance and preventive treatment based on susceptibility risk for colon and other cancers.
      BRCA1/2

      		 Breast cancer: Guides surveillance and preventive treatment based on susceptibility risk for breast and ovarian cancer.
      ResponseDx: Colon TM
      		Platinum therapies *
      		 Colon cancer: Expression profiles and mutations in ERCC1, TS, EGFR, BRAF, KRAS provide information for the selection of various therapies.
      ResponseDx: Gastric TM
      		Platinum therapies *
      		 Stomach cancer: Expression profiles and mutations in ERCC1, TS, and HER2 provide information for the selection of various therapies.
      PROGENSA PCA3 Assay

      		 Prostate cancer: Detects Prostate Cancer Gene 3 (PCA3) messenger ribonucleic acid (mRNA) in male urine specimens to generate a PCA3 Score. The PCA3 Score is intended for use in conjunction with standard-of-care diagnostic algorithms as an aid in the diagnosis of prostate cancer.
      Breast cancer IndexSM
      		Tamoxifen * (Nolvadex ®)
      		 Breast cancer: Calculates a combined risk analysis for recurrence after tamoxifen treatment for ER-positive, node-negative breast cancer.
      THxID TM BRAF Kit
      		Tramatenib * (Mekinist ®)
      		 Melanoma: Qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with Trametinib.
      Bond Oracle HER2 IHC System
      		Trastuzumab * (Herceptin ®)
      		 To determine HER2 oncoprotein status in breast cancer tissue. It is indicated as an aid in the assessment of patients for whom Trastuzumab treatment is being considered.
      HER2 CISH PharmDx Kit
      		Trastuzumab * (Herceptin ®)
      		 Determine HER2 gene status in breast cancer tissue. It is indicated as an aid in the assessment of patients for whom Trastuzumab treatment is being considered.
      HER2 FISH PharmDx Kit
      		Trastuzumab * (Herceptin ®)
      		 Quantitatively determine HER2 gene amplification in breast cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. It is indicated as an aid in the assessment of breast and gastric cancer patients for whom Trastuzumab treatment is being considered.
      HERCEPTEST
      		Trastuzumab * (Herceptin ®)
      		 Semi-quantitative assay to determine HER2 protein overexpression in breast cancer tissues. It is indicated as an aid in the assessment of breast and gastric cancer patients for whom Trastuzumab treatment is being considered.
      INFORM HER-2/ NEU
      		Trastuzumab * (Herceptin ®)
      		 Breast cancer: Determines the qualitative presence of Her-2/Neu gene amplification in human breast tissue. It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priori invasive, localized breast carcinoma and who are lymph node-negative.
      INFORM HER2 DUAL ISH DNA Probe Cocktail
      		Trastuzumab * (Herceptin ®)
      		 Intended for use in determining HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. It is indicated as an aid in the assessment of patients for whom Trastuzumab treatment is being considered.
      INSITE HER-2/NEU KIT
      		Trastuzumab * (Herceptin ®)
      		Semi-quantitative detection of over-expression of HER-2/NEU (I.E., C-ERBB-2) in normal and neoplastic tissue. It is indicated as an aid in the assessment of breast cancer patients for whom Trastuzumab therapy is being considered.
      PATHVYSION HER-2 DNA Probe Kit
      		Trastuzumab * (Herceptin ®)
      		 To detect amplification of the HER-2/NEU gene human breast cancer tissue. It is indicated as an aid in the assessment of patients for whom Trastuzumab treatment is being considered.
      PATHWAY ANTI- HER-2/NEU (4B5) Rabbit mAb
      		Trastuzumab * (Herceptin ®)
      		 Intended for laboratory use for the semi-quantitative detection of C-ERBB-2 antigen in neoplastic tissue. It is indicated as an aid in the assessment of breast cancer patients for whom Trastuzumab treatment is being considered.
      ResponseDx: Gastric TM
      		Trastuzumab * (Herceptin ®)
      		 Stomach cancer: Expression profiles and mutations in ERCC1, TS, and HER2 provide information for the selection of various therapies.
      SPOT-LIGHT HER2 CISH Kit
      		Trastuzumab * (Herceptin ®)
      		 Quantitatively determine HER2 gene amplification in breast carcinoma tissue. It is indicated as an aid in the assessment of patients for whom Trastuzumab treatment is being considered.
      Cobas ® 4800 BRAF V600 Mutation Test
      		Vemurafenib * (Zelboraf ®)
      		 Melanoma: Detects the BRAF V600E mutation in human melanoma tissue. It is designed to help select patients for treatment with Vemurafenib.
      Vysis CLL FISH Probe Kit

      		 B-cell lymphocytic leukemia: Detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL).
      Vysis EGR1 FISH Probe Kit

      		 Acute Myeloid Leukemia: Detect deletion of the LSI EGR1 probe target on chromosome 5q in bone marrow specimens and to be used, in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of acute myeloid leukemia (AML) diagnosis as an aid in determining prognosis. Deletion of chromosome 5q has been associated with an unfavorable prognosis in AML patients.
      Vysis UroVysion Bladder Cancer Recurrence Kit

      		 Bladder cancer: Detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer.
  • PSYCHIATRY

      • * Indicates a drug on which more information is available in the "Therapies" section of this site

      Test/Kit
      		Drug Name
      (Brand Name)
      		Indication
      GeneSightRx ®

      		Psychiatric disorders: Genetic variants (CYP1A2, CYP2D6, CYP2C19, serotonin transporter gene SLC6A4, serotonin 2A receptor gene 5HTR2A) in this test may affect a patient’s ability to metabolize, tolerate or respond to 26 psychotropic medications.
      PhyzioType PIMS
      		Resperidone (Risperdal ®)
      Olanzapine (Zyprexa ®)
      		 Psychiatric disorders: Predicts risk of psychotropic-induced metabolic syndrome, based on a patient’s combinatorial genotype for 50 genes.
  • RHEUMATOLOGY

      • * Indicates a drug on which more information is available in the "Therapies" section of this site

      Test/Kit
      		Drug Name
      (Brand Name)
      		Indication
      PsoriasisDx TM
      		Etanercept (Enbrel ®)
      Infliximab (Remicade ®)
      		 Psoriatic arthritis: This sequencing-based assay detects the presence of gene variant MICA-A9, indicative of an increased risk of psoriatic arthritis. Identification of risk could guide monitoring and early treat- ment with TNF-alpha antagonists.

If you have suggestions or updates for this page please contact Daryl Pritchard at dpritchard@personalizedmedicinecoalition.org. 

Resources

More Than a Number: Better Health Begins With You

A Consumer's Guide to Genetic Health Testing (PDF)

Moving Beyond Population Averages: A Patient-Centered Research Agenda Advancing Personalized Medicine (PDF)


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