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1 Your patients are unique They deserve personalized treatment New laboratory service offered by

2 STA 2 R is a panel of genetic tests that gives prescribers answers to the clinical questions below. The test report provides information regarding the potential response of individual patients to antipsychotic and antidepressant treatment based upon the information known about their genetic makeup and the influence of genetics on drug response. This information can help prescribers select the right drug at the right dose for a given patient. Is olanzapine likely to have enhanced efficacy? Do consensus data recommend avoiding risperidone due to altered metabolism? Are SSRIs likely to have decreased efficacy and increased risk of side effects? Do consensus data recommend avoiding amitriptyline and venlafaxine due to altered metabolism? Additionally, the test report provides potentially useful dosing information for the following drugs: aripiprazole, citalopram, clomipramine, clozapine, desipramine, doxepin, duloxetine, escitalopram, fluoxetine, haloperidol, imipramine, maprotiline, nortriptyline, olanzapine, paroxetine, sertraline, and trazodone.

3 Overview of genetic variants tested by STA 2 R SULT4A1-1 status Positive Consider olanzapine Olanzapine may exhibit enhanced efficacy Negative No efficacy advantage expected for olanzapine CYP2D6 metabolizer status a Poor Intermediate Extensive Ultra AVOID Risperidone Venlafaxine Amitriptyline Also see dose recommendations AVOID Risperidone Venlafaxine Also see dose recommendations Normal metabolic clearance AVOID Amitriptyline Clomipramine Paroxetine Atomoxetine Risperidone CYP2C19 metabolizer status a Poor Intermediate Extensive Ultra ADJUST DOSE Imipramine Sertraline ADJUST DOSE Imipramine Sertraline Normal metabolic clearance ADJUST DOSE Citalopram Escitalopram CYP1A2 induction a Decreased Normal Hyper Reduced clearance Olanzapine may require decreased dose Normal clearance of CYP1A2 targets Rapid clearance Olanzapine may require increased dose SLC6A4 responder status Poor Intermediate Normal Consider non-ssri antidepressant therapies, such as SNRIs or tricyclic antidepressants Possible risk of decreased or slower response to SSRIs or increased risk of adverse events a Dose and drug recommendations based on guidelines published at 1 Normal response to SSRIs expected

4 SULT4A1-1 status impacted response to olanzapine in the CATIE Study In the CATIE Study, SULT4A1-1 positive Caucasian subjects that were treated with olanzapine achieved clinically significant response (at least 20% reduction in PANSS score) more often than patients treated with any other drug. Using the response model developed in Ramsey et al, 75% of Phase I CATIE subjects who were SULT4A1-1 positive and treated with olanzapine had a clinically significant response at 18 months. Compared to other patient groups, SULT4A1-1 positive patients treated with olanzapine were more than three times as likely to achieve clinically significant response. SULT4A1-1 negative patients treated with olanzapine were no more likely to achieve clinically significant response than SULT4A1-1 negative patients treated with risperidone. Using these parameters, the figure below shows the percentage of SULT4A1-1 positive and negative Caucasian patients that achieved clinically significant response in Phase I of the CATIE Study. 2 Percentage of SUL4A1-1 positive and negative Caucasian patients that achieved clinically significant response in Phase I of the CATIE Study 2

5 1 in 5 schizophrenia patients will be hospitalized in a given year. 3 1 in 2 hospitalized patients will return to the hospital within a year. 3 Treating SULT4A1-1 positive Caucasian patients with olanzapine or quetiapine reduced the risk of hospitalization by over 80% in the CATIE Study 4 Percentage of SUL4A1-1 positive and negative Caucasian patients who returned to the hospital within one year after starting a new antipsychotic therapy in the CATIE Study 4

6 Serotonin Transporter The STA 2 R panel tests for genetic variation in the serotonin transporter gene (SLC6A4) that impacts response to SSRIs. Promoter variants lead to altered transporter production 5 Promoter SS version Lower expression SLC6A4 gene LG version Lower expression LA version Higher expression Response to SSRIs is influenced by number of LA versions of SLC6A4 6 2 copies of LA version Normal responders Expected response to SSRIs 1 copy of LA version Intermediate responder Possible increased risk of poor response and adverse events 0 copies of LA version Poor responder Increased risk of poor response and adverse events Metabolic Genes Variation in the metabolic genes CYP2D6, CYP2C19, and CYP1A2 can lead to higher or lower concentrations of drugs. Since recommended dosing assumes normal metabolism, individuals with genetic variants that impact drug metabolism may require dose adjustments or, in some cases, should avoid drugs impacted by genetic variants. 7 Increasing risk of adverse events Poor (slow) Metabolizer phenotype/rate of drug metabolism Ultra (fast) Increasing the dose may be required

7 Your PGXL healthcare professional will streamline the ordering process, sample collection, and result generation. Cheek swab by your PGXL healthcare professional Placed in overnight envelope CLIA certified lab processes sample Five to seven days later, healthcare professional receives the STA 2 R report

8 When to use STA 2 R is designed to help clinicians select pharmacotherapy for patients for whom antipsychotic and/or antidepressant medications are indicated, and as such it is best used at the following naturally occurring clinical points. Initial medication: For patients currently not on medication Treatment switch: Poor efficacy, tolerability, or satisfaction Severe treatment failure: Exacerbations of psychosis SUREGENE DOES NOT RECOMMEND STA 2 R FOR PATIENTS EXHIBITING AN ACCEPTABLE CLINICAL RESPONSE TO CURRENT THERAPY References: 1. PharmGKB Web site. Accessed September 18, Ramsey TL, Meltzer HY, Brock GN, et al. Evidence for a SULT4A1 haplotype correlating with baseline psychopathology and atypical antipsychotic response. Pharmacogenomics. 2011;12(4): Ascher-Svanum H, Zhu B, Faries DE, et al. The cost of relapse and the predictors of relapse in the treatment of schizophrenia. BMC Psychiatry Jan 7;10:2. 4. Liu Q, Ramsey TL, Meltzer HY, Massey BW, Padmanabhan S, Brennan MD. Sulfotransferase 4A1 haplotype 1 (SULT4A1-1) is associated with decreased hospitalization events in antipsychotic-treated patients with schizophrenia. Prim Care Companion CNS Disord. 2012;14(3):doi: /PCC.11m Heils A, Teufel A, Petri S, et al. Allelic variation of human serotonin transporter gene expression. J Neurochem. 1996;66(6): Serretti A, Kato M, De Ronchi D, Kinoshita T. Meta-analysis of serotonin transporter gene promoter polymorphism (5-HTTLPR) association with selective serotonin reuptake inhibitor efficacy in depressed patients. Mol Psychiatry. 2007;12(3): de Leon J, Susce MT, Pan RM, Fairchild M, Koch WH, Wedlund PJ. The CYP2D6 poor metabolizer phenotype may be associated with risperidone adverse drug reactions and discontinuation. J Clin Psychiatry. 2005;66(1): This test should not be used as the sole means of treatment decision making, and should be regarded by the ordering physician as adjunctive to the overall patient management strategy. These genotyping results do not eliminate the necessity to account for non-genetic factors that can influence dose requirements for or responses to medications that are metabolized by these enzyme systems. Drug-drug and drug-gene interactions that lead to enzymatic inhibition or induction may lead to altered metabolism. Results should always be interpreted in context with the clinical picture and all co-administered medications. The STA 2 R panel was developed by PGXL Laboratories and is conducted in PGXL s CLIA-certified facility in Louisville, KY SureGene LLC. All rights reserved

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