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PhenGene P2Y12 Test 1 CLOPIDOGREL • A second-generation thienopyridine antiplatelet agent, an antagonist of platelet P2Y12 receptor • Inhibits the formation of blood clots in the coronary, peripheral & cerebrovascular arteries METABOLISM AND ACTION OF CLOPIDOGREL 2 Problem – limited effectiveness of clopidogrel Pharmacodynamic evidence recognized by the FDA, American College of Cardiology, American Heart Association, and European Society of Cardiology suggests that clopidogrel has a suboptimal effect in a substantial proportion (“about one third”) of patients and that increasing the dose has limited efficacy in selected patients. Clopidogrel is not effective in about 1/3 of individuals One of the most prevalent reasons for reduced response to CLOPIDOGREL is inefficient conversion of the drug into its active metabolite due to genetic variability in liver enzymes 3 No easy-to-use test for clopidogrel effectiveness Clopidogrel effectiveness is not routinely measured due to • current assessment of platelet function requiring testing within a limited time of taking the blood sample • specialised equipment and technical expertise requirements on site • Ineffective treatment can increase the risk of a recurrent cardiac event or stroke • Overly effective treatment can lead to excessive bleeding 4 Our Solution To identify patients who are not responding to Clopidogrel using PhenGene P2Y12 Test that includes: • Genotyping: CYP2C19 enzyme o Involved in the metabolism of clopidogrel o Every individual has two CYP2C19 alleles o Depending on the combination of alleles in an individual, drugmetabolizing phenotypes associated with the CYP2C19 enzyme can vary • Phenotyping: assessing platelet reactivity in response to stimulation with agonists o High on-treatment thrombotic events platelet reactivity correlates with recurrent Blood samples are collected, processed using simple kit and are sent for analysis at a central laboratory – no need for specialised equipment on site and no time limitations to perform the analysis 5 Supporting Studies 6 Importance of CYP2C19 Genotyping In 2009, the US Food and Drug Administration (FDA) issued a boxed warning, recommending “consideration of CYP2C19 genotype” prior to prescribing clopidogrel. 7 OUR WORKFLOW Assess anywhere Sample Collection & Processing Sample Shipment Sample analysed Electronic reporting Patient on antiplatelet therapy can be assessed in primary care or home setting Blood sample taken and processed using simple, drug-specific kit Processed sample is Laboratory staff analyse shipped to a central sample for P-selectin processing lab in the UK using flow cytometry and CYP2C19 using Luminex Platform Complete test results are reported back electronically 8 Advantages of this combined testing • Identify at risk patients with sub-optimal response to Clopidogrel using both genotyping and phenotyping approaches • Results allow healthcare providers tailor the prescription of antiplatelet agents for their patients accordingly to reduce the risk of myocardial infarction, stent thrombosis or stroke • No capital investment is required on site to setup the testing – all that is needed is an easy-to-use testing kit to process and stabilise the blood sample, which is then sent for expert analysis to a central laboratory