Putting the Cart Before the Horse when Leading a Test to Market
April 28th, 2011
Posted by Patti Doherty, R.N.
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.
The Berkeley HeartLab 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 Journal of the American College of Cardiology 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 clinical data and peer reviewed 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 Health Protection Study 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.
Tags: Berkely HeartLab, Celera, CHD, coronary heart disease, FDA, genotype, genotype test, KIF6 gene, KIF6 StatinCheck
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