In this interview, EP Lab Digest® speaks with Nancy Lurker, CEO of PDI, Inc. about CardioPredict™, a molecular diagnostic test developed by Transgenomic, Inc. The test identifies a patient’s specific genes that will influence the effectiveness and safety of many commonly used cardiovascular drugs. PDI, Inc. and Transgenomic, Inc., recently announced their long-term collaboration agreement to commercialize CardioPredict™.
Tell us about PDI and the services you provide.
PDI is a biopharmaceutical diagnostics services and commercial services company. We supply healthcare products to physicians and healthcare providers, mostly in the prescription drug space but also in the molecular diagnostic space.
We cover a wide variety, whether it’s personal promotion, sales representatives, to medical science liaison, nurse practitioners and nurse educators, teledetailing where appropriate, and electronic digital communications as well.
How did the collaboration agreement between PDI and Transgenomic to commercialize CardioPredict™ come about?
As a company we believe that molecular diagnostics is an area that is going to increasingly play a vital role in the healthcare treatment of patients and disease. That is an area that plays very well to our strengths as a company, in that it’s a complex area. Today, a large number of practicing physicians do not have an in-depth understanding of genomics and the implications for how to use these various types of tests that are just now starting to come to market. As a result, we’re able to educate practicing physicians and healthcare providers on these new treatment modalities. As we begin to assess where the future of medicine is going, we believe molecular diagnostics is going to be a key part of that, and through a variety of different channels we came in touch with Transgenomic. I was also responsible for the global marketing of Plavix (clopidogrel) when it was first launched, so that initially interested me because I’m very familiar with that drug and the metabolism of that product, which is suboptimal for certain patients.
Tell us about the purpose of the CardioPredict™ diagnostic test and how it works. In which group of patients is it most useful for?
The purpose of the test is to ensure that the right cardiovascular drug is given to the right patient at the right dose. There are 10 genes and 40 variants in this assay, and there is a large number of patients (40-50%) who are taking either antiplatelets, anticoagulants, beta blockers, statins, antithrombotics, or antiarrhythmics. However, 40-50% of these patients are not metabolizing those drugs optimally, the way the label reads, and it’s because of these genetic variants. As a result, the patient is either getting too much or not enough drug, and the result is either lack of efficacy or increased side effects, or both. So it’s critical that healthcare providers ensure their patients are getting the right drug and dose. In particular, if you look at clopidogrel or some of the antiarrhythmics, there are major side effects including stroke, MI, arrhythmias — many of which can be life threatening. CardioPredict can help to determine in patients on these medications the effects before they take them.
How long does the testing take to complete?
Testing takes anywhere from 7-14 days to complete.
How will CardioPredict™ differ from other genetic testing options currently available to cardiovascular patients?
There are not a lot of cardiovascular assays available. The few that we know of don’t have the broad coverage of the CardioPredict™ assay. In particular, CardioPredict also has one major genetic variant for clopidogrel that has a patent pending. It’s a method of use that no one can test for, and is a very important variant that affects 23% of all patients on clopidogrel.
When will CardioPredict™ be commercially available?
CardioPedict will start being commercially available in the first quarter of 2014. We’ve started a small launch this November and will roll out more significantly by late first quarter or early second quarter.
Can you discuss the role that pharmacogenetic testing and personalized medicine will play in the future in the cardiovascular therapeutic area? How have these areas evolved?
The cost to run genomic assays is dropping substantially and the speed is accelerating. The result is that the use of these types of tests, whatever the therapeutic area, is going to increasingly become a key part of how physicians practice medicine. That includes everything from how patients metabolize drugs (in any category of drugs), to what their risk for myocardial infarction is as an example, to what their stroke risk is on a genetic basis. Right now, oncology is at the forefront of this type of testing. They are beginning to be able to characterize tumors much more specifically, and that only is going to accelerate until we are able to tailor the drug treatment for the tumor type. So the oncology space is on the leading edge at the moment, and their abilities are only going to grow. What we’re going to see in the future is that almost every drug that is launched will have a companion diagnostic with it. Everything from propensity for a disease, to metabolizing of drugs, to treatment of that disease, is going to be much more characterized by patient’s genetic profiles and that’s going to increasingly play a very large role in the delivery of medicine.
Patients with various risk factors for a disease or with a preexisting disease are all put into the same clinical trial to see what happens. We know that no matter what category they are put in, a large number of patients will be non-responders, and today there is no way to tell who those patients will be specifically. If you’re lucky, you will have a large number of responders in your trial. If not, you’re going to get a large number of nonresponders, and in some cases, drugs get abandoned even though they might be incredibly effective for a particular type of patient.
Until now, there was no way of knowing on whom a particular drug would be effective or not. However, now we will be able to determine this on a genetic basis. Lives are going to be saved with this approach to personalized medicine.
Is there anything else you’d like to add?
Physicians need to be on the lookout, particularly for patients who might be on Plavix (clopidogrel) or other cardiovascular medicines. If these patients do not seem to be responding well, consider getting some information about CardioPredict and using it as a tool to reduce the “wait and see” time and be more accurate in deciding treatment regimens for specific conditions.
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