Monday, August 24, 2009

Executive Spotlight: David Levison, Founder, CEO and Director of CardioDx

CardioDx is a personalized medicine company that develops and commercializes genetic based cardiac diagnostic tests. The company is currently developing several molecular diagnostics that will help physicians determine appropriate treatment for cardiovascular patients. CardioDx is using both genetics and genomics technologies to develop these unique diagnostic products. David Levison, the founder, CEO and director, who was previously a venture capitalist and CEO of a couple of start ups, including XDx and iScribe, talked with me about what it's like to run a start-up, how CardioDx is seeking a competitive edge in the cardiovascular testing market and how he thinks diagnostics might hold the key for more efficiently spending our healthcare dollars.

Q: Tell me about CardioDx, its products and what’s in the pipeline.
A: CardioDx is a four-year old genomic diagnostics company focused exclusively on cardiovascular disease. In June of this year, we launched our first product, Corus CAD, which is a gene expression test to aid in the assessment of obstructive coronary artery disease. This test is designed to help physicians identify which patients with chest pain are likely to have enough plaque in their coronary arteries that it is obstructing blood flow to their heart. This first test is intended for non-diabetics, but we are working on a product version for diabetic patients. We’re also working on prognostic applications of this product—so, say a patient’s score goes up over time, we’re looking at what that may mean in terms of disease progression. Additionally, we’re looking at multiple technology modalities; this first test is based on the expression of certain genes, but there could be applications for proteomics and/or genetics as well. In addition, CardioDx has an ongoing prospective clinical trial in arrhythmia and sudden cardiac arrest risk stratification to identify patients who would be good candidates for receiving implantable cardioverter defibrillators, or ICDs. Right now clinicians have suboptimal diagnostic tools to determine who would be ideal recipients for these sophisticated therapy devices. In fact, studies have indicated that a majority of these devices implanted in patients may never need to deliver therapy, or “fire”.

Q: How does the Corus CAD test work?
It’s a gene expression test that measures how the activity of certain genes in peripheral blood reflects the state of disease in the coronary arteries. It’s a central lab test (CLIA), so a blood sample is drawn by a clinician in an office or lab and shipped overnight to our lab in Palo Alto. The results, in the form of a score, which correlates to the probability that the patient has obstructive coronary disease, are sent to the clinician within two days. Clinicians should use the Corus CAD test results in conjunction with other tests in their patient assessment, and our U.S. clinical trial (PREDICT) results indicate that a low patient score reflects a low probability that obstructive coronary disease exists. And finally, Corus CAD provides a safe, noninvasive, and less restrictive means of assessing obstructive coronary disease without patient exposure to radiation or imaging agents, which many patients do not tolerate well—we think that’s pretty important, too.

Q: How is this condition currently diagnosed?
Currently, obstructive coronary artery disease is being assessed in numerous and varying ways: clinicians consider a patient’s personal or family history of cardiovascular disease, the type of chest pain they’re having, and numerous other clinical variables that impact the likelihood a given patient has coronary artery disease. Many times noninvasive imaging modalities are utilized, such as echocardiography or myocardial nuclear perfusion. These procedures are not entirely benign for all patients, and they are costly and time-consuming.

Q: How many people work at CardioDx and how many locations do you have?
We have about 70 people working in research and development, clinical and regulatory, sales and marketing, our commercial CLIA lab, and operational administration roles. Our primary location is in Palo Alto, but others are spread throughout the country working on our clinical trials and commercializing Corus CAD in our initial sales territories.

Q: Which companies do you view as your main competitors and what are your main competitive advantages?
Well, our competitors can also be our greatest collaborators. Certainly we would count the large labs like Quest and LabCorp, both of whom have product menus into which we would strategically fit. We’ve also been monitoring how successful Celera has been in terms of its introduction of the Berkeley HeartLab product line. We are unique in terms of our genomic diagnostics focus on cardiovascular disease, but there are certainly other companies out there that also serve cardiologists. I believe our product development cycle is a key differentiator for CardioDx—because we spend a tremendous amount of time to understand what clinicians need day to day, and we create detailed product specifications before investing heavily on R&D. We’ve also created competitive advantage through a multifaceted team of people from the device, pharmaceutical and diagnostic worlds with extensive experience in cardiovascular product commercialization. Lastly, we have proven our ability to drive multicenter, prospective clinical trials like PREDICT and DISCERN, which is our arrhythmia trial. Developing a product like Corus CAD requires that you rigorously control large, well annotated patient sample collections and the clinical data collection associated with them. It’s an expensive and time-consuming undertaking, but you must have high quality data in order to develop high quality products.

Q: What changes can we expect in your industry in the coming years?
The last 20 years have seen tremendous progress in the development of effective new drugs and medical devices to treat a wide variety of diseases. The diagnostics tools that are necessary to determine which patients should receive these new therapies have not kept pace with the new drugs and devices. As an industry, we must now apply the same rigor to the development of diagnostics that can appropriately direct these new technologies to the patients who need them. Right now it seems the diagnostics world is playing catch-up to the therapeutic world, and there appears to be a real disconnect—for example, only 3 percent of healthcare dollars are spent on diagnostics, but that cost drives another 70 percent of the cost of healthcare. There’s a tremendous opportunity to improve diagnostics to more efficiently deploy our therapeutic dollars, and we believe that genomics has given us an incredible tool with which to do this. I expect that the diagnostics industry will be a key component to improving the delivery of healthcare.

Q: What segment of your business do you see as the primary growth driver this year and next?
Corus CAD and its follow-on products will be the key drivers for CardioDx over the next couple of years.

Q: What do you hear from your customers about your products?
Both cardiologists and primary care physicians tell us that their traditional tools don’t allow them to do as good a job with assessing coronary artery disease as they’d like. Physicians looking for a new way to assess their patients with chest pain are embracing Corus CAD—they understand that the new era of genomics has brought them unique, objective biological insight that adds to their clinical capabilities today. As far as patients are concerned, the idea of a convenient blood-based test that assesses their coronary disease likelihood without radiation exposure strongly resonates. Payers love the idea of more efficiently directing the right patients into the healthcare system to ensure they get the procedures they need.

Q: What keeps you up at night?
Besides my five children aged 7 to 17…I ask myself if we are doing all we can to develop these tests and get them to the market as soon as possible. We’ve launched in only nine states. We wanted to be sure we knew how physicians were going to integrate the test into practice and make sure we have all the tools in place for them before launching nationwide.

Q: What do you do to relax?
I spend as much time with my wife and kids as possible. Relaxation isn’t always the first word that comes to mind.

Q: If your house were on fire, what would you grab?
The hard drive with all the family photos.

Q: When you were young, what did you aspire to be as an adult?
I always thought that being involved in small companies would be fun. My early career experience is actually more in information technology, but I’m delighted that I’ve moved to the healthcare side. It’s so gratifying to do well and do good at the same time.

Q: Do you have any regrets?
Not as relates to CardioDx. One of the real advantages is learning from those who’ve come before us. We’ve been able to learn from the mistakes and successes of other molecular diagnostic companies. We’ve certainly made our own mistakes, but we try to learn from them and not make the same mistakes over again.

Q: How do you want people to remember you?
I think I’m most proud of meeting the challenges of building companies that improve the lives of patients every day.

CHI-Advancing California biomedical research and innovation

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