Roche Amplichip CYP450 (IVD)
In 2005 DNAVision was chosen by Roche Diagnostics as official service provider for Amplichip CYP450 testing.
The AmpliChip™ CYP450 test is the world's first pharmacogenetic microarray-based test approved for clinical use (cleared for in vitro diagnostic use in the US and EU).
The AmpliChip CYP450 Test provides comprehensive coverage of gene variations - including deletions and duplications - for the CYP2D6 and CYP2C19 genes, which play a major role in the metabolism of an estimated 25% of all prescription drugs. It is intended to be an aid for physicians in individualizing treatment selection and dosing for drugs metabolized through these enzymes.
Clinical Utility
- FDA & EU cleared for diagnostic analysis of two critical drug metabolism genes: CYP2D6 and CYP2C19
- Identifies poor metabolizers prior to therapy to help avoid adverse drug reactions
- Identifies ultra-rapid and intermediate metabolizers for pre-therapeutic drug adjustment to maximize drug efficacy
- Approximately 10% of Caucasians are poor metabolizers, 35% intermediate, 48% extensive and 7% ultra-rapid
Drugs Metabolized by CYP2D6 and CYP2C19
Approximately 25% of prescription drugs are metabolized by CYP2D6 and CYP2C19
Genes |
Mutations |
Substrate Examples |
CYP2D6 |
*2,*3,*4,*5,*6,*7,*8,*9,*10,*11,
*14A,*14B,*15,*17,*19,*20,*25,
*26,*29,*30,*31,*35,*36,*40,*41,
1XN,2XN,4XN,10XN,17XN,
35XN,41XN |
Beta-blockers
Carvedilol
Metoprolol
Propafenone
Timolol
Anti-depressants
Amitriptyline
Clomipramine
Desipramine
Imipramine
Paroxetine
Venlafaxine
Anti-psychotics
Haloperidol
Risperidone
Thioridazine
Others
Codeine
Dextromethorphan
Flecainide
Mexiletine
Ondansetron
Tamoxifen
Tramadol |
CYP2C19 |
*2,*3 |
Proton pump inhibitors
Omeprazole
Lansoprazole
Pantoprazole
Anti-epileptics
Diazepam
Phenobarbitone
Phenytoin
Others
Amitriptyline
Clomipramine
Cyclophosphamide
Progesterone |
Roche AmpliChip™ CYP450 process
Customer Benefits
- Broad allelic coverage
High built-in sensitivity analyzing 29 polymorphisms and mutations for the 2D6 gene and 2 polymorphisms for the 2C19 gene, thereby enabling more accurate determination of patient's the genotype and predicted phenotype (poor, intermediate, extensive, or ultra rapid metabolizer). Accurately genotypes over 99% of the world's population.
- All-in-One
Tests for the 31 polymorphisms and mutations, including gene deletions and duplications, in a single assay.
The only test that also analyzes the functional status of gene duplications.
- Automatic Analysis
Automatically determines genotype and predicted phenotype when used with Roche proprietary software.
- Gold Standards
AmpliChip microarray-based tests combine Roche's patented PCR technology, the gold standard in nucleic acid amplification, with Affymetrix leading microarray technology.
- Computer-assisted Analysis
Results are obtained and interpreted by computer analysis performed on a scan showing the pattern of hybridization of the patient sample to a series of probes (arrayed on the glass substrate) that are specifically complementary to either wild-type or mutant sequences.
Amplichip CYP450 testing at DNAVISION
- Fast turn-around time (5 days) from samples reception
- Validated process
- Large expertise in Affymetrix and PCR technology
- Pharmacogenetics specialized laboratory
We give you more than genotypic and phenotypic data (EM, UM, IM, PM). We provide you also with a Drug Regimen Assessment Report (optional)
Reporting
We provide you with:
- genotypic data (e.g. CYP2D6*1/*4)
- phenotypic data (EM, UM, IM, PM)
- and also a drug regimen assessment report including:
- evaluation of the Patient's current drug regimen against their genetic CYP results using recent scientifically validated information to improve drug therapy
- identification of important CYP related drug-drug interactions in the Patient's current regimen that can affect treatment outcomes
- personalized prospective drug assessment chart.
Sample Requirements
The AmpliChip CYP450 test is for use with whole blood specimens only.
Peripheral blood collected in an EDTA (lavender top) tube is required; we need 3 ml. The samples should be refrigerated at 4°C and send by express courier (Fedex, DHL, …).
Please send all the samples to:
DNAVision SA
Avenue Georges Lemaître 25
6041 Belgium
Europe
Tel: 003271378527
Fax: 003271378501
Email: info@dnavision.be
Prices and Ordering
Please inquire for ordering information.
An invoice will be sent for each test.
Payment is possible by credit card (Visa or MasterCard), or by bank transfer to the DNAVision bank account at the ING bank
Belgium only: 360-0107565-95
International: IBAN: BE76 3600 1075 6595 BIC: BBRUBEBB
To order a test please fill out the patient submission form and add this to the 2 custom forms (if you are outside of Belgium). Contact us for more information.
