Boston Heart Diagnostics (BHD) announced today the commercial launch of the Statin Induced Myopathy (SLCO1B1) Genotype test licensed from the University of Oxford's technology commercialization company Isis Innovation. This adds to the company's IP portfolio and suite of cardiovascular disease (CVD)-focused tests that are designed to improve outcomes for patients and save health dollars by tailoring a therapeutic regimen to the patient's particular circumstances. The new test, which BHD offers through its Framingham-based CLIA lab, identifies patients who are at higher risk for developing severe myopathy (muscle aches and pain) as a side effect of statin drugs prescribed to reduce low-density lipoprotein cholesterol (LDL-C) levels. Oxford University made the SLCO1B1 discovery and has granted BHD an exclusive U.S. license for the marker. Additionally, the U.S. Patent and Trademark Office has approved the patent application for Prioritized Examination under its fast-track patent examination program. A final decision is expected before the end of 2012.
About 40 million Americans take statins annually to lower LDL-C and reduce the risk of heart attack and stroke. Statins have helped reduce mortality from cardiovascular disease, yet it is still the number one cause of death in the U.S. According to Boston Heart Diagnostics Chief Medical Officer, Ernst Schaefer, M.D., the SLCO1B1 gene is critical to the body's uptake and metabolism of these important drugs. Studies show that statin users who have one copy of a particular inherited variation at the SLCO1B1 gene location are about five times more likely to suffer myopathy of varying severity as a side effect (approximately 9 million people). However, for the roughly 1.2 million people that carry two gene variations, the likelihood of experiencing myopathy is 18-times higher and the effects can be incapacitating. Despite their proven efficacy, studies estimate that 25 to 50 percent of patients who are prescribed statins stop taking their medications as directed – many of whom do so because of statin induced muscle aches, spasms, and pain.
"Of course there are any number of reasons that people ignore their healthcare provider's advice, but statin induced myopathy can be extremely unpleasant and, for a small percentage, completely debilitating – leading many to forego taking the potentially life-saving drug," said BHD President and CEO, Susan Hertzberg. "Armed with the right information, clinicians can prescribe alternatives that are more appropriate. This test is another example of how Boston Heart Diagnostics is helping to fulfill the promise of personalized medicine. The Statin Induced Myopathy Genotype test is designed to help healthcare providers identify in advance those patients who are at higher risk for negative side effects due to a variation in their SLCO1B1 gene, and accordingly prescribe the right drugs at the right doses."
The presence of this common variant to SLCO1B1 results in significantly decreased ability to take up statins, less effectiveness of the statin in lowering so-called "bad" cholesterol levels, higher blood levels after dosing, and an increased risk of myopathy. This risk is especially pronounced in those receiving high doses of the lipophilic statins simvastatin and atorvastatin. The physician or healthcare provider should consider using lower doses of water-soluble statins (pravastatin 20 mg/day or less, pitavastatin 2 mg/day or less, rosuvastatin 10 mg/day or less, or fluvastatin 20 mg/day or less) and adding ezetimibe or colesevelam therapy to augment LDL-C lowering response if needed.
"We are delighted to assist in bringing this important new test to the U.S. market through an exclusive arrangement with Boston Heart Diagnostics," said Tom Hockaday, Managing Director of Isis Innovation, the technology transfer company of Oxford. "The Statin Induced Myopathy Genotype test, developed at Oxford's Clinical Trials Services Unit by Professor Rory Collins' group, will allow Boston Heart Diagnostics to assist patients and physicians to choose the best treatment option for their particular case."
SOURCE Boston Heart Diagnostics