Putting the Cart Before the Horse when Leading a Test to Market

April 28th, 2011
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Berkeley HeartLab’s experience with its KIF6 StatinCheckTM highlights the discrepancies between how well a test is marketed versus its clinical utility.
In 2008, the assay KIF6 StatinCheck genotype test was introduced as a laboratory developed test.  More than 250,000 tests, with a price tag of about $100 each, have now been performed. In December of 2010, Celera (Berkeley HeartLab’s parent company) submitted a pre-market approval application to the U.S. Food & Drug Administration (FDA) based on several studies. These studies suggested a relationship between carriers of the KIF6 gene and an increased risk of coronary heart disease (CHD) and statin response.
TheBerkeleyHeartLab states the test’s clinical value on its website as follows:

KIF6 genotyping provides significant information beyond traditional risk factors to help with the identification of patients at risk for CHD events and the personalization of their treatment. Kinesin-like protein 6 (KIF6) is a protein involved in intracellular transport. A single nucleotide polymorphism (SNP) of KIF6 (719 Arg) has been shown to predict increased coronary heart disease (CHD) risk and event reduction during statin therapy.

However, what started as a test to better identify persons at risk for CHD and help predict which patients should receive statin therapy has now become engulfed by studies disproving the link between the KIF6 gene and risk of CHD.
In October of 2010 a meta-analysis reported in the JournaloftheAmericanCollegeofCardiology refuted the utility of the test.  Other studies have followed suit along with researchers and physicians voicing concerns over the lack of clinical utility.
Further adding fuel to the unfavorable articles that appear to be eroding the success of the test, the FDA denied the company pre-market approval for the assay because clinicaldataandpeerreviewed publications submitted did not sufficiently support the safety and efficacy of the test.
Some of the key issues stem from the lack of analytical and clinical validity as well as clinical utility. For example, investigators within the HealthProtectionStudy stated concern that the test could do more harm than good for those without the gene who may not receive statin therapy when in fact they should be treated.
This case clearly exemplifies the discrepancies between how well a test is marketed versus the clinical utility of the test. Perhaps the block in the road may be the impetus for Celera or others currently developing a similar test to create better tests. Ultimately, clinical utility is and should be the value driver for a diagnostic test.
Do you agree? Are there other examples that point to the imbalance between marketing means and clinical utility? Please share your thoughts below.

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About the Author:

I have 20 years experience in clinical research, including leading diagnostic and pharmaceutical clinical studies in disease areas ranging from cancer to infectious disease to cardiology, diabetes, and autoimmune disorders. Send me an email.

2 Responses to “Putting the Cart Before the Horse when Leading a Test to Market”

  1. Meghan O'Neil says:

    A friend had this test and she showed me the results. Somehow it all seemed so “glossy” and overwhelming. Also I questioned if it is just a drug company’s way of getting more use for their drugs. Here in Florida there are a lot of us older people. Is this really a useful test for someone not experiencing a heart problem? I agreed to do some research on what people think about the test. Can you steer me to some articles that are objective? So far the articles I have found are really just advertisements for clinics that administer the test. We see a lot of that down here. I want something that steps back and gives a clinical analysis of the need and usefulness of this expensive test for the average person. Thanks for you help