As of September 2016
Click on the "+" icons below to view tables with information on selected personalized medicine tests.
* 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. |
* 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. |
* 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.
|
* 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. |
* 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. |
* 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.
|
HERCEPTEST | Pertuzumab * (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. |
* 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. |
* 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.