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.