1. PhenGene
P2Y12 Test

2. CLOPIDOGREL METABOLISM AND ACTION OF 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

3. Clopidogrel is not effective in about 1/3 of individuals
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

4. 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

5. Our Solution
To identify patients who are not responding to Clopidogrel using PhenGene P2Y12 Test that includes:
Genotyping: CYP2C19 enzyme
Involved in the metabolism of clopidogrel
Every individual has two CYP2C19 alleles
Depending on the combination of alleles in an individual, drug- metabolizing phenotypes associated with the CYP2C19 enzyme can vary
Phenotyping: assessing platelet reactivity in response to stimulation with agonists
High on-treatment platelet reactivity correlates with recurrent thrombotic events
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

6. Supporting Studies

7. 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.

8. Sample Collection & Processing
OUR WORKFLOW
Assess anywhere
Patient on antiplatelet therapy can be assessed in primary care or home setting
Sample Collection & Processing
Blood sample taken and processed using simple, drug-specific kit
Sample Shipment
Processed sample is shipped to a central processing lab in the UK
Sample analysed
Laboratory staff analyse sample for P-selectin using flow cytometry and CYP2C19 using Luminex Platform
Electronic reporting
Complete test results are reported back electronically

9. 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