Editing DeCODE genetics (section)

== Product innovation ==
deCODE's scientific leadership over more than twenty years has enabled it repeatedly to pioneer new types of partnerships, products and applications for many aspects of precision medicine. Between 1998 and 2004, the company signed high-profile and innovative partnerships with pharmaceutical companies [[Hoffmann-La Roche|Roche]], [[Merck & Co.|Merck]], [[Bayer]], [[Wyeth]] and others. These alliances provided research funding to advance deCODE's work, with goals of finding genetically validated new drug targets in common diseases; to develop DNA-based diagnostics, that could gauge risk of disease or predict drug response and identify patients most likely to benefit from a drug; and to design "information-rich" clinical trials that would enroll participants with particular genetic variants, with the potential to make trials smaller, more informative, and with a greater chance of success.<ref>Brief summary of the company's collaborations and business lines in its [https://sec.report/Document/0001104659-06-016794/ 2005 10K] {{Webarchive|url=https://web.archive.org/web/20200318210423/https://sec.report/Document/0001104659-06-016794/ |date=18 March 2020 }}, pp. 9-10</ref>

In 2002, deCODE acquired a Chicago-based medicinal chemistry company in order to discover compounds based on its genetics discoveries and so to begin to develop its own pipeline of new drugs.<ref>"DeCode to Acquire MediChem Life Sciences in $84M Stock Deal," ''[https://www.genomeweb.com/archive/decode-acquire-medichem-life-sciences-84m-stock-deal#.XlO9sFP7R25 Genomeweb]'', 8 January 2002</ref> Over the next few years the company initiated and completed several early-stage clinical trials for potential new treatments for heart attack, peripheral artery disease, and conducted work with partners on asthma and [[Spinal muscular atrophy|SMA]].<ref>Company press release, "deCODE genetics, Inc. Provides Product Development Update -- CEP-1347, DG041, DG031, DG051," republished in ''[https://www.biospace.com/article/releases/decode-genetics-inc-provides-product-development-update-cep-1347-dg041-dg031-dg051-/ Biospace],'' 26 June 2006</ref> These were early examples of what would today be called '[[precision medicine]]' programs: using genetics for target discovery and to select trial participants by testing them for disease susceptibility through the same pathway targeted by the drug.<ref>{{Cite journal |last=Hakonarson |first=Hakon |last2=Thorvaldsson |first2=Sverrir |last3=Helgadottir |first3=Anna |last4=Gudbjartsson |first4=Daniel |last5=Zink |first5=Florian |last6=Andresdottir |first6=Margret |last7=Manolescu |first7=Andrei |last8=Arnar |first8=David O. |last9=Andersen |first9=Karl |last10=Sigurdsson |first10=Axel |last11=Thorgeirsson |first11=Gestur |last12=Jonsson |first12=Asgeir |last13=Agnarsson |first13=Uggi |last14=Bjornsdottir |first14=Halldora |last15=Gottskalksson |first15=Gizur |date=2005-05-11 |title=Effects of a 5-Lipoxygenase–Activating Protein Inhibitor on Biomarkers Associated With Risk of Myocardial Infarction: A Randomized Trial |url=http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.293.18.2245 |journal=JAMA |language=en |volume=293 |issue=18 |pages=2245 |doi=10.1001/jama.293.18.2245 |issn=0098-7484|url-access=subscription }}</ref>

In the mid-2000s, deCODE launched a new kind of risk diagnostic focused largely on prevention and wellness. These DNA-based diagnostic tests detected genetic variants identified by deCODE and others that correlated with significantly increased individual risk of common diseases including heart attack,<ref>[https://www.decode.com/decode-launches-decode-mi-a-test-for-a-major-genetic-risk-factor-for-early-onset-heart-attack/ Company press release], "deCODE Launches deCODE MI™ – A Test for a Major Genetic Risk Factor for Early-onset Heart Attack," 11 October 2007</ref> atrial fibrillation and stroke, type 2 diabetes, common (non-BRCA) breast cancer, prostate cancer and glaucoma.<ref>A list of the tests and example of how their utility was described in [https://www.decode.com/decode-launches-decode-breastcancer-a-genetic-test-to-screen-for-risk-of-the-most-common-forms-of-breast-cancer/ company press release], "deCODE Launches deCODE BreastCancer™, a Genetic Test to Screen for Risk of the Most Common Forms of Breast Cancer," 8 October 2008</ref> The type 2 diabetes test, for example, was based on published studies that showed that approximately 10% of people carried two copies of deCODE's highest impact risk variant, putting them at twice the average risk of developing diabetes, independent of obesity. The medical purpose of the test was "to identify prediabetics at higher than average risk of progressing to full-blown diabetes, and that these same individuals can effectively counteract this added risk through weight loss and through the use of certain medications."<ref>[https://www.decode.com/decode-launches-decode-t2-a-novel-dna-based-test-for-assessing-inherited-risk-of-type-2-diabetes/ Company press release], "deCODE Launches deCODE T2™, a Novel DNA-based Test for Assessing Inherited Risk of Type 2 Diabetes," 15 April 2007</ref>

Another novel characteristic of these tests was the integration of multiple, well-validated genetic risk factors. The overall impact of these different risk factors was combined and calculated into what was called a [[Polygenic score|polygenic risk score]], placing the individual on a spectrum of risk with regard to that of the population in general, independent of and in addition to other health or lifestyle risk factors.<ref>Example of SNPs included in [https://www.snpedia.com/index.php?title=DeCODEme deCODEme in SNPedia]</ref> With each new discovery, deCODE could broaden the risk factors tested. The idea was to make screening and prevention strategies and therapies more specific and more effective for those at higher risk, and hopefully to provide new incentive for individuals to follow through with well understood lifestyle modification such as weight loss, smoking cessation, etc.<ref>New variant added to deCODE AF in [https://www.decode.com/decode-discovers-second-common-genetic-risk-factor-for-atrial-fibrillation-and-stroke/ company press release], "deCODE Discovers Second Common Genetic Risk Factor for Atrial Fibrillation and Stroke," 13 July 2009</ref> This was the essence of what was then called [[personalized medicine]], but because these tests were new, their medical usefulness was as yet unproven. As everyone is by definition at risk of common diseases, and doctors generally understood genetic risk only as it referred to rare diseases, the medical community approached these tests with skepticism.<ref>On continued skepticism for common disease testing even in 2019, see Ian Sample, "NHS abandons plan to let healthy people pay for DNA sequencing," ''[https://www.theguardian.com/society/2019/jul/25/nhs-scraps-its-plan-to-sell-dna-tests-to-healthy-people Guardian]'', 25 July 2019</ref> In 2018, advocacy for the use of polygenic risk scores for identifying those at significantly increased risk of common diseases, and using whole-genome data and new algorithms to build on many early deCODE markers, began a revival.<ref>{{Cite journal |last=Khera |first=Amit V. |last2=Chaffin |first2=Mark |last3=Aragam |first3=Krishna G. |last4=Haas |first4=Mary E. |last5=Roselli |first5=Carolina |last6=Choi |first6=Seung Hoan |last7=Natarajan |first7=Pradeep |last8=Lander |first8=Eric S. |last9=Lubitz |first9=Steven A. |last10=Ellinor |first10=Patrick T. |last11=Kathiresan |first11=Sekar |date=September 2018 |title=Genome-wide polygenic scores for common diseases identify individuals with risk equivalent to monogenic mutations |url=https://www.nature.com/articles/s41588-018-0183-z |journal=Nature Genetics |language=en |volume=50 |issue=9 |pages=1219–1224 |doi=10.1038/s41588-018-0183-z |issn=1061-4036 |pmc=6128408 |pmid=30104762}}</ref>

To judge by the intense media coverage of deCODE's discoveries, ordinary people were very certainly interested in these genetic risk factors and how they might be relevant to their health. In late 2007, the company effectively launched the field of personal genomics with its deCODEme<ref>[https://www.decode.com/decode-launches-decodeme/ Company press release], "deCODE Launches deCODEme™," 16 November 2007</ref> direct-to-consumer (DTC) scan aimed at enabling people to better understand their risk of common diseases and use this information to stay healthy. deCODEme hit the market a day before the now widely known, Google-funded [[23andMe]].<ref>{{Cite news |last=Wade |first=Nicholas |date=2007-11-16 |title=Company Offers Genome Assessments |url=https://www.nytimes.com/2007/11/16/science/17gene.html |access-date=2025-04-28 |work=The New York Times |language=en-US |issn=0362-4331}}</ref> deCODEme's marketing emphasized its pedigree, seriousness and scientific rigor: "provided by a world leader in the discovery of genetic risk factors for disease...[so that its customers] benefit directly from the knowledge and experience of scientists carrying out internationally renowned research" (its competitors used deCODE's published variants as the basis for many of their results); with the scan processed in the same labs that had found them. By 2012, the deCODEme complete scan measured one million SNPs and calculated risk for 47 common diseases and traits as well as basic information on maternal and paternal ancestry, noting that most ancestry scans of the period were not back by much data.<ref>See the [https://web.archive.org/web/20120715000728/http://www.decodeme.com/scientific-leadership archived version of deCODEme website] from July 2012.</ref>

Despite deCODEme's emphasis that its results were for informational purposes — "a roadmap to improve your health" — and the provision of genetic counseling for users who had questions about their results, US regulators quickly took a critical view of disease risk assessments being put directly in the hands of consumers.<ref>California cease-and-desist letters to testing companies in Andrew Pollack, "Gene Testing Questioned by Regulators," ''[https://www.nytimes.com/2008/06/26/business/26gene.html New York Times]'', 26 June 2008</ref> In June 2010, the FDA wrote to deCODE<ref>[https://wayback.archive-it.org/7993/20170112084830/http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215241.pdf FDA letter to deCODE], 10 June 2010</ref> and its main competitors to say that they considered such scans to be medical devices requiring FDA approval.<ref>FDA Letters to 23andMe, Navigenics and Knome, in Andrew Pollack, "F.D.A. Faults Companies on Unapproved Genetic Tests," ''[https://www.nytimes.com/2010/06/12/health/12genome.html New York Times]'', 11 June 2010</ref> Facing regulatory headwinds and then corporate reorganization, deCODE stopped selling deCODEme in late 2012.<ref>Turna Ray, "With deCODE purchase, Amgen gains expertise, consumers lose DTC testing option," ''[https://www.genomeweb.com/diagnostics/decode-purchase-amgen-gains-genetics-expertise-consumers-lose-dtc-testing-option#.Xm6waRP7R24 Genomeweb]'', 12 December 2012</ref> In 2017, the FDA began to approve certain assessments of genetic risk for disease in consumer tests.<ref>[https://web.archive.org/web/20190518001549/https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-direct-consumer-tests-provide-genetic-risk-information-certain-conditions FDA press release], "FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions," 6 April 2017</ref>

In 2018, deCODE broke new ground with a direct intervention in public health and the first national genetic screening program of its kind. The company launched a website that enables anyone in Iceland to ask the company - free of charge - to search their whole genome sequence data to determine whether they are likely carriers of a SNP in the BRCA2 gene that confers high risk of breast and prostate cancer in Iceland. Within months, ten percent of the population had requested their BRCA2 status, and the National Hospital has built up its counseling and other services to help people follow up on their preliminary results and use the information to protect their health.<ref>Statistics in "NACG 6th Clinical workshop report," [https://nordicclinicalgenomics.org/assets/resources/201811-nacg-6th-ws-report-final.pdf Nordic Alliance for Clinical Genomics] {{Webarchive|url=https://web.archive.org/web/20190510173313/https://nordicclinicalgenomics.org/assets/resources/201811-nacg-6th-ws-report-final.pdf |date=10 May 2019 }}, 21 November 2018, p.9</ref>