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The Genomadix Cube CYP2C19 System is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA obtained from a buccal swab sample. The Genomadix Cube CYP2C19 System can be used to aid clinicians in determining therapeutic strategy for therapeutics that are metabolized by the cytochrome P450 2C19 gene product, specifically *2, *3, and *17 alleles. This test is not intended to be used to predict drug response or non-response. The Genomadix Cube CYP2C19 Test Kit is indicated for use with the Genomadix Cube CYP2C19 Platform.

The Genomadix Cube CYP2C19 System is a sample-to-result DNA testing system with integrated DNA extraction and amplification. Genotypes are determined using Polymerase Chain Reaction (PCR) and fluorescent probe detection. The Genomadix Cube CYP2C19 System is comprised of the Genomadix Cube CYP2C19 Platform (Genomadix Cube, computer, and barcode scanner) and the Genomadix Cube CYP2C19 Test Kit (swabs and cartridges). The test is run on the Genomadix Cube CYP2C19 Platform. The Genomadix Cube is a thermal cycling instrument that automatically integrates extraction of DNA from the buccal sample, PCR amplification, fluorescence-based detection of CYP2C19 alleles, and genotype calling.

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The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response. The xTAG® CYP2C19 Kit v3 is indicated for use with the Luminex® 100/200™ instrument or MAPGIX® with xPONENT® software systems.

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The Spartan RX CYP2C19 System is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and *17 genotype determined from genomic DNA obtained from a buccal swab sample. For prescription use only. Spartan RX CYP2C19 Assay - The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Assay will be run on the Spartan RX CYP2C19 Platform from the buccal sample collected with a buccal swab. The Spartan RX CYP2C19 Assay is not indicated to be used to predict drug response or non-response. Spartan RX CYP2C19 Platform - The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Platform will be used to run the Spartan RX CYP2C19 Assay.

The Spartan RX CYP2C19 System is a sample-to-result DNA testing system that uses proprietary technology to integrate DNA extraction and amplification. Genotypes are determined using PCR and fluorescent probe detection. The Spartan RX CYP2C19 System is comprised of the Spartan RX liadrooom prable a and Spartan RX CYP2C19 Assays. The Spartan RX CYP2C19 Assays are run on the Spartan RX CYP2C19 Platform. The Spartan RX CYP2C19 System is based on the following processes: - Buccal swab collection i. - ii. DNA extraction - PCR-based amplification of the target gene lii. - Detection of the *2, *3, and *17 alleles using fluorescent-probes iv. - Fluorescent signal detection and analysis V. - Genotype determination vi. The Spartan RX CYP2C19 System integrates and automates steps ii to vi. Results are presented to the end user as genotype calls. The system also has integrated controls that monitor performance of a run and automatically inform the user of any anomalies in the instrument or reagents. The system detects the CYP2C19 *2, *3, and *17 genotypes in separate reagent tubes. The operator collects buccal swab samples from a patient; inserts each sample into a reagent tube; and then inserts the reagent tubes into a Spartan RX Analyzer instrument.

The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from an EDTA or citrate anticoagulated whole blood sample. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand- alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

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The Verigene® CYP2C19 Nucleic Acid Test (CYP2C19 Test), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of an individual's CYP450 2C19 genotype in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test) is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP450 2C19 gene product, specifically *2, *3, and *17. The Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test) is not indicated to be used to predict drug response or non-response.

The Verigene® System is comprised of test consumables and shared instrumentation. All Verigene tests are formatted in self-contained test-specific Verigene Test Cartridges which serve to analyze a nucleic acid sample that is presented to them. Nucleic acids are prepared directly from a whole blood specimen using magnetic glass particles and input automatically into a Test Cartridge inside the Verigene Processor SP. Test progress is tracked and directed by the Verigene Reader instrument, which serves as a central control unit for each Verigene System. Genomic DNA is extracted from the white blood cells in a whole blood specimen, fragmented and denatured. This fragmented, single-stranded genomic DNA hybridizes to complementary sequence-specific DNA oligonucleotides, known as capture oligonucleotides, arrayed on the surface of a substrate (glass slide). A second DNA oligonucleotide is then hybridized to the captured genomic DNA that was captured initially. This oligonucleotide is known as a mediator oligonucleotide containing two sequence domain is complementary to the genomic DNA target and a second domain is complementary to a common oligonucleotide attached to a signal generating gold nanoparticle probe. After washing away any DNA not affixed to the captures, the probe is exposed to the captured mediator/target compound where it hybridizes to any captured mediators. Presence of the gold nanoparticle probes at a particular location on the substrate is assessed optically. The Verigene CYP2C19 Nucleic Acid Test is designed to detect and genotype the CYP450 2C19 *2, *3 and *17 alleles. The test report lists the alleles and provides which genotype was detected in the specimen. The CYP2C19 Test algorithm automatically calculates each of the allele results using a preset normalized ratio of the signal of wild type capture locations on the microarray to the mutant capture locations on the microarray.

The INFINITI CYP2C19 Assay is an in vitro diagnostic test for the identification of a patient's CYP450 2C19 genotype in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI CYP2C19 Assay is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The INFINITI CYP2C19 Assay is indicated for use as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP450 2C19 gene product, specifically *2, *3, *17. The INFINITI CYP2C19 Assay is not indicated to be used to predict drug response or non-response.

The INFINITI CYP2C19 Assay is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management, and software technology for the detection and genotyping of the 2C19 *2, *3, and *17 mutations in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI CYP2C19 Assay is comprised of the BioFilmChipTM Microarray, the Intellipac Reagent Module and the PCR Amplification Mix. The INFINITI CYP2C19 Assay should be run using the AutoGenomics INFINITI Analyzer. The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific. The Intellipac Reagent Module contains up four reservoirs that house the test reagents and has an integrated memory chip. Information on the reagent such as lot number, expiration date and remaining tests, are archived in the memory. The PCR Amplification Mix consists of the reagents needed for the PCR amplification step of the assay. The INFINITI CYP2C19 Assay is based on the following processes: (a) DNA extraction (b) PCR amplification of purified DNA from human genomic DNA (c) Labeling of the amplified product (allele specific primer extension) (d) Hybridization of the labeled amplified product to a microarray by signature Tag/Capture probe hybridization under isothermal conditions. (e) Scanning of the microarray (f) Signal detection and analysis Steps (c) through (f) are automated by the INFINITI Analyzer. The INFINITI Analyzer automates the 2C19 assay and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, and results The assays are processed automatically and read by the built-in confocal analysis. microscope. Results are analyzed and presented as genotype calls.

The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or nonresponse.

The xTAG CYP2D6 Kit v3 includes the following components: - xTAG® 2D6 v3 PCR Primer Mix A - xTAG® 2D6 v3 PCR Primer Mix B - xTAG® 2D6 v3 ASPE Primer Mix - xTAG® 2D6 v3 Bead Mix - xTAG® 10x Buffer - xTAG® Shrimp Alkaline Phosphatase - xTAG® Exonuclease I - xTAG® Streptavidin, R-Phycoerythrin Conjugate - Platinum TI Exo(-) DNA Polymerase - Platinum® Tfl Reaction Buffer, 5x - Tfi 50mM MgCl3 - xTAG® Hot Start Taq (Long Acting) - xTAG® 10x Tag Buffer (Long Acting) - xTAG® Data Analysis Software (TDAS) CYP2D6

The Invader® UGTIA1 Molecular Assay is an in vitro diagnostic test for the detection and genotyping of the *1 (TA6) and *28 (TA7) alleles of the UDP glucuronosyltransferase 1A1 (UGTIA1) gene in genomic DNA from whole peripheral blood as an aid in the identification of patients with greater risk for decreased UDP-glucunorosyltransferase activity.

The Invader® UGTIA1 Molecular Assay is an in vitro diagnostic test which utilizes sequence specific Invader DNA probes, a structure-specific cleavage enzyme and a fluorescent resonance energy transfer (FRET) system combined with universal interpretative software and third party microtiter plate reader instrumentation. Invader® is the term used to generically refer to the patented chemistry on which the Invader® UGT A 1 Molecular Assay is based. The assay is designed to identify specific nucleic acid sequences and query for the presence of known sequence polymorphisms through the structurespecific cleavage of a series of probes that are specifically complementary to TA repeat sequences in in the "TATA Box" of of the UGT1A1 promoter region. In the Invader® UGT1A1 Molecular Assay, two oligonucleotides (a discriminatory Primary Probe and an Invader® Oligo) hybridize in tandem to the target DNA to form an overlapping structure. The 5'-end of the Primary Probe includes a 5'-flap that does not hybridize to the target DNA. The 3'-nucleotide of the bound Invader® Oligo overlaps the Primary Probe, but need not hybridize to the target DNA. The Cleavase® enzyme recognizes this overlapping structure and cleaves off the unpaired 5'-flap of the Primary Probe, releasing it as a target-specific product. The Primary Probe is designed to have a melting temperature close to the reaction temperature. Therefore, under the isothermal assay conditions, Primary Probes, which are provided in excess, cycle on the target DNA. This allows for multiple rounds of Primary Probe cleavage for each target DNA, and amplification of the number of released 5'-flaps. In the secondary reaction, each released 5'-flap can serve as an Invader® Oligo on a fluorescence resonance energy transfer (FRET) Cassette to create another overlapping structure that is recognized and cleaved by the Cleavase® enzyme. When the FRET Cassette is cleaved, the fluorophore and quencher are separated, generating detectable fluorescence signal. Similar to the initial reaction, the released 5'-flap and the FRET Cassette cycle, resulting in amplified fluorescence signal. The initial and secondary reactions run concurrently in the same well. The biplex format of the Invader® UGT1A1 Molecular Assay enables simultaneous detection of two DNA sequences, a non-varying segment of the human alpha actin (ACTAI) gene and the TA repeat in the TATA box of the human UGTIA1 gene, in a single well. The biplex format uses two different discriminatory Primary Probes, each with a unique 5'-flap, and two different FRET Cassettes, each with a spectrally distinct fluorophore. By design, the released 5'-flaps will bind only to their respective FRET Cassettes to generate a target-specific signal. The Invader® UGT1A1 Molecular Assay utilizes four independent wells per sample (one well for each of the TA Oligo mix reactions), to make a single genotype call. Each well contains a TATA box specific probe and an alpha actin probe. The alpha actin probe serves as an internal control to confirm the validity of a given result when a particular TATA box polymorphism is absent.

The AmpliChip CYP450 test is intended to identify a patient's CYP2C19 genotype from genomic DNA extracted from a whole blood sample. Information about CYP2C19 genotype may be used as an aid to clinicians in determining therapeutic strategy and treatment dose for therapeutics that are metabolized by the CYP2C19 gene product.

The AmpliChip CYP450 Test is based on five major processes: PCR amplification of purified DNA: fragmentation and labeling of the amplified products; hybridization of the amplified products to a microarray and staining of the bound products; scanning of the microarray; and determination of the CYP450 genotype and predicted phenotype. The AmpliChip CYP450 Test is designed to identify specific nucleic acid sequences and query for the presence of known sequence polymorphisms through analysis of the pattern of hybridization to a series of probes that are specifically complementary either to wildtype or mutant sequences. Microarrays of oligonucleotide probes synthesized on a glass substrate are utilized for the analysis.