As a follower of deCodeYou, we wanted to let you know about some important developments in the company and how we believe these will underpin our ability to continue to keep you in the forefront of understanding what the latest advances in genetics mean for you and your health.

For the past several months, deCODE has been working on restructuring its operations. As a result of these efforts, deCODE has entered into and filed concurrently with its Chapter 11 petition announced today an asset purchase agreement under which it would sell its Iceland-based human genetics operation to new owners. This is the subsidiary that conducts our human genetics research, manages our population genetics resources and provides our personal genome scans and DNA-based risk assessment tests. This agreement is subject to a number of contingencies, including a competitive bidding procedure and court approval in accordance with bankruptcy law. It also provides interim financing to enable us to continue operations during the Chapter 11 process, and we have asked the court for the customary authority to continue to provide products and services to our customers without interruption during the bankruptcy process.

Thus you should expect to continue to hear from here on all the latest in human genetics and its relevance to health and healthcare. You can read our press release here.

With best regards,

The deCODEyou team

deCODE Discovers Second Common Genetic Risk Factor for Atrial Fibrillation and Stroke. Will be integrated into deCODE AF™ DNA-based risk assessment test, and into the deCODEme™ and deCODEme Cardio™ scans.

Scientists at deCODE genetics and colleagues from Europe and the United States today report the discovery of a common single-letter variant in the sequence of the human genome (SNP) conferring increased risk of atrial fibrillation (AF) and stroke. The findings will be integrated directly into the deCODE AF™ reference laboratory test for gauging individual risk of AF and stroke and helping to identify stroke patients who may benefit from enhanced monitoring for AF. The study is published online today in Nature Genetics.

The new SNP is in the ZFHX3 gene on chromosome 16q22, and the more than one third of people of European descent who carry one copy are at approximately 20% greater risk of AF and cardioembolic stroke than are individuals who carry none. AF is the most common type of cardiac arrhythmia, and is a major risk factor for stroke. Because AF is often intermittent and difficult to detect, gauging genetic susceptibility can help doctors to decide which of their stroke patients might benefit from longer-term monitoring for AF following a stroke. Those with stroke due to AF may be given different therapy than they would otherwise. This is the purpose of deCODE AF™, at the heart of which is the major AF and stroke variant discovered by deCODE on 4q25. Indeed today’s findings are the result of deCODE’s program to build on this work and to find new risk variants. After expanding their genome-wide association study in Iceland, the deCODE team took the top SNPs outside the 4q25 region and typed them in case-control cohorts from Iceland, Norway and the United States. This confirmed the ZFHX3 SNP as a risk variant for AF. Analysis in stroke cohorts from Iceland, Germany, Sweden and the UK demonstrated that this SNP was associated with increased risk of stroke, particularly cardioembolic stroke.

“This is an important discovery and all the more gratifying because we can integrate it straight into a test that is already helping to improve patient care in the clinic.
As with our 4q25 variant, this latest discovery has been replicated in numerous populations by us and others, and the connection to cardioembolic stroke is yet further evidence that we are putting our finger on an important pathway involved in AF and stroke risk. The ability to routinely test for these risk factors means that we can understand whom we should screen intensively for AF and then prescribe the drugs most suited to the cause of a particular patient’s disease. This is the sort of personalized medicine that genetics is enabling – individualized care that may mean not only better outcomes but significant potential savings to the healthcare system. Discoveries like this are the foundation upon which this transformation is being made,” said Kari Stefansson, CEO of deCODE.

deCODE and the authors wish to thank the participants who took part in this study and made it possible. Financial support for this study was provided by US National Institutes of Health grants HL075266 and U01 HL65962 and American Heart Association grant 0940116N; by the German Federal Ministry of Education and Research (01GI9909/3), by the German Migraine & Headache Society (DMKG), and by unrestricted grants of equal share from Astra Zeneca, Berlin Chemie, Boots Healthcare, Glaxo-Smith-Kline, McNeil Pharma, MSD Sharp & Dohme and Pfizer to the University of Muenster.

Crown Prince Frederik of Denmark and Crown Princess Marie of Denmark along with deCODE scientist Unnur Thorsteinsdottir during an official visit to deCODE laboratories earlier this year.

Reykjavik, ICELAND, December 8, 2008 – deCODE genetics (Nasdaq:DCGN) today announced the discovery by an international consortium of scientists from deCODE and major European and US academic institutions of a single letter variation in the human genome (SNP) that is associated with increased fasting glucose levels and risk of type 2 diabetes (T2D). deCODE will employ its CLIA-registered genotyping laboratory and existing testing platform to swiftly integrate the finding into its deCODEme™ personal genome scan, and to assess the addition of this new variant to the company’s deCODE T2™ reference laboratory test for assessing individual risk of type 2 diabetes.

The multinational study analyzed a number of SNPs that had been suggestively linked with fasting glucose levels in several major studies involving some 36,000 individuals from Europe and the United States.The analysis identified a version of single SNP within the gene encoding melatonin receptor IB (MTNR1B) that was associated with notable increase in fasting glucose levels. The deCODE team then demonstrated in its Icelandic cohort that this SNP also associated with an increased risk of T2D, a finding that was then replicated in a meta-analysis of data from more than 80,000 cases and controls from Europe and the US. Approximately 10% of the participants in this study carry two copies of the at-risk version of this SNP, putting them at more than 15 percent greater risk of type 2 diabetes than individuals who carry no copies. The paper, entitled “Variants in MTNR1B influence fasting glucose levels,” is published today in the online edition of Nature Genetics, and will appear in an upcoming print edition of the journal.

“This finding is another step towards rounding out our understanding of the genetic factors that underpin glucose regulation and risk of type 2 diabetes. This variant does not confer sufficient risk to be of clinical utility on its own. But when measured in addition to our TCF7L2 variant that is the anchor of the deCODE T2™ test, it may, like other common variants conferring modest risk, enable the test to capture an even larger proportion of inherited risk. We are currently evaluating its integration into deCODE T2™, because understanding genetic risk of T2D enables individuals and their physicians to focus, personalize and improve prevention. In the meantime, we will be enabling our deCODEme subscribers to check their profiles for this new variant, keeping them at the cutting edge of human genetics” said Kari Stefansson, CEO of deCODE.

Type 2 diabetes: A major public health problem
T2D is a chronic condition that develops when the body either becomes resistant to or doesn’t secrete enough insulin. Diabetes affects nearly 200 million people worldwide and, according to the American Diabetes Association, some 21 million in the United States. The vast majority of these have T2D, and as many as one third of Americans with diabetes may not even be aware that they have the disease. More than 50 million Americans have pre-diabetes, a condition characterized by elevated blood glucose levels and which puts these individuals at high risk for developing T2D. T2D can be managed and – most importantly – prevented. If losing weight, eating better and getting adequate exercise aren’t enough, there are also medications that can help to manage blood sugar levels and insulin response to reduce the likelihood of developing diabetes. For more information on T2D and how to prevent it, you can go to the American Diabetes Association’s website.

Breast Cancer Network of Strength was started by Mimi Kaplan and Ann Marcou.

Attitudes towards breast cancer have changed quite a lot over the past three decades, a fact evidenced by the outpouring of response when stars such as Olivia Newton-John, Kylie Minogue, and, most recently, Christina Applegate, went public with their personal struggles with the disease. But this change in attitude is also reflected in many other ways and not least in the adoption of a new name for the patient advocacy and support organization that until now called itself Y-ME? Tomorrow, a gala event held at the Fairmont Hotel in Chicago will celebrate Breast Cancer Awareness Month and the evolution of Y-ME, 30 years on, into the Breast Cancer Network of Strength-a change they hope that will better communicate the organization’s mission to promote a proactive, engaged and positive approach to fighting breast cancer.

Started in 1978 by librarian Mimi Kaplan and social worker Ann Marcou (both breast cancer patients hailing from Chicago), the newly named Breast Cancer Network of Strength includes a 24-hour hotline with interpreters in 150 languages, as well as an internet-based support system where breast cancer patients can share their stories. Breast Cancer Awareness Month (BCAM) has a slightly shorter history but the pink ribbons you have seen everywhere for the past two weeks (one of which you are hopefully wearing right now) are now a familiar sight worldwide.

Alongside a number of other organizations, deCODE genetics is working on the preventative side of matters via ongoing research into the genetic risk factors for breast cancer. Last week deCODE genetics launched deCODE BreastCancer^TM, a new tool for assessing risk of the common forms of breast cancer (that are also the result of environmental and lifestyle factors) and for targeting intensive screening and early detection for women at high risk of the disease. deCODE BreastCancer^TM aims to put the power of genetic risk assessment to work for the majority of women, complementing the use of tests for variants in the BRCA1&2 that cause rarer, highly familial forms of the disease.

MainStreet.com – How to Fight Breast Cancer Without Giving Money

Breast Cancer Network of Strength

In a recent interview Dr. Kari Stefansson, C.E.O. of deCODE genetics talked about the future for genetic tests such as deCODEme and how he believes that they will drive the shift from intervention to prevention in medicine

Lauralee Nygaard, a periodontist from Spokane, WA, says the deCODE tests are easy to take and highly cost effective but that we have to pay close attention to the results and be prepared to make some serious lifestyle changes.

Lauralee Nygaard is a dentist from Spokane, Washington. She is in her early forties and has two young children. Three years ago Lauralee had a stroke while she was performing surgery on a patient. It confirmed her suspicions about a predisposition to heart disease that she had nurtured since she was 18.

“When I was 18, I went to the doctor and said, ‘I know I’m at risk for a heart attack, my dad has hypercholesterolemia.’ The doctor laughed at me. He said, ‘you’re a skinny girl, you’re never going to have heart disease.”

A stroke at forty confirmed her worst fears: “It corroborated the fact that I knew I was at risk. I had pushed my family physician for years to be aggressively preventative with making sure I didn’t have heart disease. He always told me there was nothing they could do.”

As a dentist who had stressed the importance of preventative care for years, Lauralee was ready to practice what she had preached

Finding the right program

Lauralee had heard about the Heart Attack & Stroke Prevention Clinic in Spokane, Washington from some of her patients who had been through the program there and spoken very highly of it. She was impressed from the very start:

“For me it was one of the most unique health care experiences. My first appointment was three hours long—I had never spent three hours in a physician’s office! They spent a lot of time looking at my family history, asking questions about my uncles and my aunts and other people in the family, and going over my symptoms and educating me about heart disease and we did some follow-up tests.”

After taking the deCODE test she discovered, alarmingly, that her risk for heart attack and stroke was considerably higher than the average.

The program at Heart Attack & Stroke Prevention Clinic was quite unlike anything she had experienced before: “I had seen my physician annually for my entire life. I’d always had perfect blood pressure, always had perfect blood work. So, for them to say that ‘well, you had a stroke we’re not sure why’—I just thought, what did they miss? I mean there’s got to be something else. That was just really disturbing. Was I at risk because someone missed something?”

Lauralee expressed her disappointment and frustration with what she calls the ‘five-minute, drive-by doctor’s appointment’. She explains: “even if a physician wants to give you options, he’s not allowed to if he’s on certain insurance plans,” and that most physicians are restricted under the present system.

However, she insists that paying out of her own pocket at the Heart Attack & Stroke Prevention Clinic allowed nurse practitioner Amy Doneen “to have time with patients and be more preventative in terms of her approach to disease.” Lauralee adds that the costs of preventative treatment, as opposed to those incurred after an incident such as stroke or heart attack, are minimal.

The benefits of genetic testing
“To me, the benefit of doing the genetic test is that I can reduce my risk of having another stroke and permanent damage. It’s a short life, you know . . .”

deCODE offers genetic testing for a range of inheritable diseases. This, Lauralee believes, is part of a more efficient and more cost effective method of treatment.

“The motivation for me to follow through with the genetic test was the fact that my mother’s health had been failing rapidly and she had had four strokes in the last six months. She had just been diagnosed with diabetes and was not doing well. I had never really figured out why I had a stroke. Then Amy Doneen at Heart Attack Prevention Clinic suggested that atrial fibrillation (irregular heart rhythm) might have played a role. She explained to me that 30% of cryptogenic stroke diagnosis comes from atrial fibrillation and that this condition was ‘preventable’ with the right medication.”

To her surprise, Lauralee tested negative for the diabetes gene she believed she had inherited from her mother. But the test results affirmed that her stroke has not been a random catastrophe and she did indeed have a genetic disposition for atrial fibrillation. The next step was to take blood thinners that would reduce the risk of clotting after irregular heart rhythm and subsequently reduce the risk of having a stroke.

“The genetic test gave me information (that confirmed with my past stroke) that I am at risk for future strokes. Now, instead of saying, ‘Oh well, I had a stroke. I got lucky—no big deal,’ I can actually make some choices with my health care and avoid another stroke altogether.” Lauralee’s mother had suffered a series of strokes over a short period of time and she did not want to follow along the same path.

“My kids are little—I have kids that are 8 and 10 years old and I would like to be around to see them become productive adults. I think if I could gain some information, I’d be more proactive in my health—I think there’s a lot of benefit in that.”

By the same token, she believes that her children have “so many more preventative options” and could be tested at a much younger age and therefore hopefully avoid an incident altogether. She did not want them to have to wait till 40 or 50 and/or the occurrence of a massive event. Finding out early that they could be at risk would mean earlier intervention.

Modifying behavior for optimum health
Lauralee explains a healthy future is a matter of first getting as much information as possible and then modifying one’s behavior:

“I think things are changing. We’re learning more about how being aware impacts people. I think the more you can learn about your risks, the more you can modify your behavior and the more you can hopefully prevent something that’s going to harm or shorten your life.”

Of course, knowledge can be intimidating, but only if one is not willing to make lifestyle changes. Lauralee claims that the people who are frightened of what genetic testing can offer are mainly those who don’t want to change how they’re living. She admits she had to make some serious changes in her own life, changes that she frowned on several years before her stroke.

Cost effective
Lauralee says some people are naturally concerned about costs and the fact that their insurance might not pay for genetic testing. However, if you find out you are at risk before you damage anything, you can save a great deal. She believes that preventative medicine and genetic testing are highly cost effective!

“We know that a simple swab from the inside of your mouth can gauge your disease risk—that’s a very cost effective test to figure out what your disease predispositions are. Certainly, being more aggressive in prevention is going to lower health care costs over time. For example, it would have cost a lot less for me to know that I was at risk than to have 3 MRIs—in terms of health care expense. On the national scale, heart disease, diabetes, and stroke are some of the greatest issues facing health care in this country at the moment and they’re eating up a good chunk of our health care budget.

Better decisions, better health
After describing the test as “ridiculously easy,” Lauralee admitted that some fears were “a generational issue.” Younger people are much more comfortable with technology and knowledge and do not regard knowing what their genetic makeup is as threatening. People will soon learn that knowledge is power and that it allows us to take better care of our health and make better decisions. She admits, though, that any fears she might have had are allayed by a background in biology. She certainly did not shy away from being proactive: “I mean, I think that you can never ever regret what you invest in taking care of yourself. One body, one life, one chance.”

Does that mean she was glad to have an early warning?

“Yes, totally—it was a blessing. I was very fortunate I got a warning and could shape a path for myself. Not everyone does. 70% of all first heart attacks or strokes result in death for patients.”

She ends by telling us how the pharmacist reacted to her new medication regime:
“My pharmacist, who looks sixteen, said: ‘Can I ask you a personal question? Why are you taking all this medicine?’ (blood thinners, blood pressure and cholesterol medications) I said ‘you mean the medicine of an 80-year-old?—that’s because I want to live to be 80!’”

In its work on the inherited components of dozens of common diseases, deCODE has discovered gene variants that significantly affect individual susceptibility or protection against disease. In the common forms of these conditions – such as obesity, type 2 diabetes and cardiovascular diseases – deCODE has previously shown that genetic variants confer increased or decreased risk by up-regulating or down-regulating the activity of major biological pathways.

In today’s paper, the deCODE team and collaborators from Merck demonstrate one of the principal ways in which the activity of biological pathways is functionally perturbed in a quintessentially complex condition: obesity.

Kari Stefansson, CEO of deCODE, put the study into context: “One of the observations we have made in our work on the isolation of disease genes is that the genetic risk of common diseases is often conferred by variations in the sequence of the genome that affect expression of genes. Hence, one of the ways to approach the study of common diseases is through the analysis of gene expression. This paper provides a substantial contribution towards the understanding of gene expression in man and one example of how it can be used to expand our knowledge of one disease, namely obesity.”

These latest SNPs are the fourth set of variants that deCODE has linked to prostate cancer risk. They are single-letter variations in the genome – SNPs – located on chromosome 2 and on the X chromosome. The SNPs confer relatively modest increases in risk – of approximately 20% and 15% per copy carried, respectively – but because they are also quite common they are each believed to contribute to about 5% of prostate cancer cases. They were found through the analysis of 300,000 SNPs in 23,000 Icelanders in deCODE’s prostate cancer studies, and then confirmed in an analysis of more than 15,500 individuals from seven different cohorts from Europe and the United States.

Published studies by major academic research groups in the United States and Europe have over the past month provided strong validation of the role of the other common risk variants, on chromosomes 8 and 17, discovered by deCODE in 2006 and 2007. Altogether, the prostate cancer risk variants now included in deCODEme™ contribute to more than 50% of all cases of the disease. Because of these variants, 10% of men are at twice the risk and 1% of men are at three times the risk of the disease in the general population.

For those subscribers who believe they should consider having a DNA-based diagnostic test for prostate cancer risk variants that they can use with their doctor, deCODE has also just launched deCODEPrCa™, the first such test aimed at understanding individual risk of the disease.