Reykjavik, ICELAND, November 11, 2008 – In a presentation today at the American Heart Association Scientific Sessions 2008, clinicians and researchers from Baylor College of Medicine have presented data from the Atherosclerosis Risk in Communities (ARIC) study, demonstrating that measuring the genetic risk factor on chromosome 9p21 detected by the deCODE MI™ test complements traditional risk factors to improve the assessment of individual risk of future coronary heart disease (CHD). This information can be used to more accurately assess target cholesterol levels and to inform lipid-modifying therapy recommendations.
Last year, deCODE discovered single-letter variations in the human genome (SNPs) on chromosome 9p21 that increase risk of heart attack, and launched its deCODE MI™ reference laboratory test to enable clinicians to measure this risk factor as part of their efforts to provide the best preventive strategies for their patients. In the study today, the Baylor team and colleagues from other academic institutions analyzed the clinical utility of testing for the 9p21 risk factor by adding it to a range of standard CHD risk factors followed by ARIC, a major, NIH-funded prospective study of cardiovascular disease and care begun in 1987. Through an analysis of more than 10,000 ARIC participants of European descent for whom 9p21 status was known, the study found that knowing the 9p21 risk made the assessment of individual risk more accurate and resulted in the reclassification from one risk category to another of a significant proportion of the overall cohort. The impact was most pronounced in the categories of intermediate risk, in which individuals were estimated to be at a 5–10% risk of CHD in the next ten years, and intermediate-high, with individuals at an estimated 10 –20% 10-year CHD risk. In these categories, 19% and 17% of people, respectively, were shifted to a different risk category as a result of integrating their 9p21 status. This reclassification would result in a change in target LDL-cholesterol levels and thus in recommended lipid-lowering therapy.
“The results of this study demonstrate that integrating deCODE MI™ into the standard list of risk factors now used to assess CHD risk can improve the prediction of risk of future cardiac events. This provides physicians with a more accurate basis upon which to target cholesterol levels for individual patients and thus for tailoring statin use, in addition to addressing other risk factors such as obesity, smoking and hypertension. The study is all the more important because deCODE MI is available to clinicians today through our CLIA-registered laboratory,” said Dr. Kari Stefansson, M.D., Dr. Med., CEO of deCODE.
About deCODE MI™
deCODE MI™ is a DNA-based test for identifying individuals at increased risk for myocardial infarction (MI). It is a reference laboratory test which detects versions of SNPs in the CDKN2A/2B gene region on chromosome 9p21. deCODE genetics has reported, based on studies of thousands of patients in multiple cohorts from the US and Europe, that individuals who are positive for this test are at approximately 1.6-times higher risk of MI, and at approximately twice the risk of early-onset MI (before age 50 in men and age 60 in women) than are those without the genetic risk variants. About 20% of people of European descent are positive for this test. deCODE’s findings have been confirmed in multiple studies in the US, Canada, United Kingdom and Europe.
How to order deCODE MI™
Additional information and physician order forms for deCODE MI™ can be found at www.decodediagnostics.com. The price of the test is $200 dollars and deCODE facilitates reimbursement from commercial insurers. Testing is performed in deCODE’s CLIA-registered laboratory, which has analyzed the genomes of hundreds of thousands of people from around the globe.
deCODE is a bio-pharmaceutical company developing drugs and DNA-based tests to improve the treatment, diagnosis and prevention of common diseases. Its lead therapeutic programs, which leverage the company’s expertise in chemistry and structural biology, include DG041, an antiplatelet compound being developed for the prevention of arterial thrombosis; DG051 and DG031, compounds targeting the leukotriene pathway for the prevention of heart attack; and DG071 and a platform for other PDE4 modulators with therapeutic applications in Alzheimer’s disease and other conditions. deCODE is a global leader in human genetics, and has identified key variations in the genome (SNPs) conferring increased risk of major public health challenges from cardiovascular disease to cancer. Based upon these discoveries deCODE has brought to market a growing range of DNA-based tests for gauging risk and empowering prevention of common diseases. Through its CLIA-registered laboratory, deCODE offers deCODE T2™ for type 2 diabetes; deCODE AF™ for atrial fibrillation and stroke; deCODE MI™ for heart attack; deCODE ProCa™ for prostate cancer; deCODE Glaucoma™ for a major type of glaucoma; and deCODE BreastCancer, for the common forms of breast cancer. deCODE is delivering on the promise of the new genetics.SM Visit us on the web at www.decode.com; on our diagnostics site at www.decodediagnostics.com; for our pioneering personal genome analysis service, integrating the genetic variants included in these tests and those linked to another twenty common diseases, at www.decodeme.com; and on our blog at www.decodeyou.com.
Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results, and the timing of events, to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, the effect of a potential delisting of our common stock from The Nasdaq Global Market, uncertainty regarding potential future deterioration in the market for auction rate securities which could negatively affect our cash position and result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE’s filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10-K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.