How do genetic variations affect cardiovascular drug effectiveness?
People inherit different versions of any particular gene, and some genes affect how patients process and metabolize medicines. This especially holds true for people with cardiovascular (CV) disease. They may be fast, slow or non-metabolizers and might also react badly (with serious adverse events) to certain drug therapies or not at all.
A large subset of cardiovascular disease patients (20-50%) respond poorly to “standard of care” medicines due to their genetic make-up. Adverse outcomes, including risk of CV death, myocardial infarction, or stroke have been demonstrated to align to the genetic makeup, or genotype, that the patient inherited. Historically, this response could not be predicted in advance of prescribing or taking a medication.
Please can you introduce the molecular diagnostic test that Transgenomic have developed to identify patients’ genes that may influence the effectiveness of cardiovascular drugs?
CardioPredictTM is a broad-based genetic assay that identifies a patient’s specific genes that influence the effectiveness and safety of many commonly used cardiovascular drugs such anti-coagulants (blood thinners) statins (cholesterol lowering drugs), beta blockers and antiarrhythmics.
This new molecular diagnostic test panel analyse more than 40 genetic markers in 10 genes shown to be important for predicting how individual patients may respond to a cardiovascular drug. The most common of these medications include clopidogrel, atorvastatin calcium, simvastatin, warfarin, and more.
CardioPredict is a very comprehensive commercially available test for predicting cardiovascular drug response, and the only one that includes the critical ABCB1 gene, shown to impact patients’ ability to absorb clopidogrel.
How does the test work?
CardioPredict(TM) Pharmacogenomic Optimization Panel provides healthcare professionals the ability to tailor cardiovascular treatment to an individual patient's genotype.
DNA obtained within a buccal swab is analyzed to identify polymorphisms, or variations of a particular DNA sequence within genes. CardioPredict(TM) assesses polymorphisms within 10 genes that correlate with cardiovascular drug responsiveness--ABCB1, CYP2C19, CYP2C9, VKORC1, CYP2D6, CYP3A4, CYP3A5, Factor V, Factor II, and MTHFR.
A customized patient report summarizes the results and provides a detailed pharmacogenomic profile that informs the healthcare professional of the patient's genetic predisposition towards absorption, activation, and metabolism of specific cardiovascular medications. The report also provides clinical implications to help guide healthcare professionals in tailoring their treatment, including dose adjustments or use of alternative therapies that do not have genetic limitations.
How useful is this information to physicians who have to make drug selection and dosing decisions?
The availability of CardioPredict makes the knowledge of patients’ individual genetic makeup (related to these genes) available in broad commercial panel available for the first time, which can help in choosing drugs and dosing more effectively.
If a patient is found to possess certain genes variants, physicians can prescribe alternative therapies that are not as dependent on genetic limitations right away, rather than taking a ‘wait and see’ approach to selecting a treatment. The easy-to-interpret CardioPredict™ test results help physicians to individualize CV therapies for each of their at-risk patients to achieve optimal therapeutic benefits. The test will only need to be performed once to provide a lifetime of therapeutic guidance.
Transgenomic recently partnered with PDI, Inc. to commercialize this test. What are the next steps in this process?
We are introducing CardioPredict in a few key markets initially this year, and plan to make it fully available in the U.S. early in 2014. We have sales representatives in the field engaging with physicians regarding the test, which is being made available.
What impact do you think this test will have?
We believe that CardioPredict will enable to physicians to help better manage their at-risk patients, through this personalized approach to medicine, and accelerate the process of getting them on the right treatment.
What are PDI’s and Transgenomic’s plans for the future?
At PDI, we are focused on successfully commercializing CardioPredict and look forward to a mutually beneficial relationship with Transgenomic through our eight-year agreement and beyond to help address the growing population of high-risk patients with CV disease and the physicians that help treat them.
Do you have plans to develop similar tests for other types of drug?
PDI’s strategy involves plans to commercialize additional molecular diagnostic tests, although it is too early at this time to discuss them specifically.
About Nancy Lurker and Paul Kinnon
Nancy Lurker, CEO, PDI, Inc.
Nancy Lurker, a veteran in the biopharmaceutical industry, joined PDI in November 2008 as Chief Executive Officer and a member of the company’s Board of Directors. Ms. Lurker has more than 25 years of experience in pharmaceutical sales, marketing, and commercial operations. Prior to joining PDI, she was Senior Vice President and Chief Marketing Officer for Novartis Pharmaceuticals Corporation (the US subsidiary of Novartis AG), where she oversaw a product portfolio in multiple therapeutic areas representing multi-billion dollars in annual sales. Ms. Lurker was also President and CEO of ImpactRx, Group Vice President-Global Primary Care Products for Pharmacia Corporation, and a member of Pharmacia’s US Executive Management Committee. She began her career at Bristol Myers Squibb, where she quickly rose from Senior Sales Representative to Senior Director of Worldwide Cardiovascular Franchise Management during her 14-year tenure. Ms. Lurker graduated magna cum laude with a BS in biology and chemistry from Seattle Pacific University, and holds an MBA from the University of Evansville (Evansville, IN).
Paul Kinnon, CEO, Transgenomic
Mr. Paul Kinnon has been Chief Executive Officer and President of Transgenomic Inc. since September 30, 2013. He served as Chief Executive Officer and President of ZyGEM (also known as, ZyGEM Corporation Limited) since October 2007 and also served as its Chief Executive of North American operations. Mr. Kinnon joined ZyGEM in 2007 from Invitrogen Corp. (now Life Technologies), where he held the positions of Vice President of Global Strategic Alliances and Vice ... President and General Manager of the Applied Markets Business Unit. Mr. Kinnon has over two decades of business and scientific leadership in the biotechnology and pharmaceutical industries. Previously, Mr. Kinnon served as Vice President of Sales and Marketing of Guava Technologies where he helped it evolve into a cellular analysis business and as Vice President of Sales of Cellomics, where he built the high Content Screening (HCS) business after initially establishing Cellomics European operation. He has also held marketing and business roles in leading companies such as Porvair, Caliper, Whatman and Thermo Instrumentation. Mr. Kinnon earned his Bachelor of Applied Chemistry at Coventry University in the UK; holds a Diploma of Marketing and is a member of the Chartered Institute Marketing & Association of Strategic Alliance Professionals.
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