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HolGenTech, Inc. Blog & News
HoloGenomics News here Blog & News Table of Contents [Jun 16] The Path to Personalized Medicine [Apr 19] Nestle Joins the Fray after P&G - Potentially Targeting Consumers with Personalized Data [Apr 12] Francis Collins: DNA May be a Doctor's Best Friend [Mar 03] Genome Service Available for Predicting Illnesses [in Korea and Asia] [Feb 10] Personalized Medicine and Procter & Gamble? Consumer Products and Genetic Testing? Blog & News Full Comments The Path to Personalized Medicine [See full article blogged] Calming the seas of speculation and concern stirred by recently issued FDA letters, Dr. Margaret Hamburg, Commissioner for FDA, and Dr. Francis Collins, Director of NIH, have laid out the path to Personalized Medicine in a jointly authored article that appeared in the most prestigious New England Journal of Medicine (June 15, 2010). Likely to dispel panic, their path appears in laymen's terms to be a long-range plan, above the level of any single government agency, and probably foundational to legislation to be proposed at the impending Congressional Investigation: "When the federal government created the national highway system, it did not tell people where to drive — it built the roads and set the standards for safety. Those investments supported a revolution in transportation, commerce, and personal mobility. We are now building a national highway system for personalized medicine, with substantial investments in infrastructure and standards. We look forward to doctors' and patients' navigating these roads to better outcomes and better health." FDA Did Not Crack Down on DTC Genome Testing [See full article blogged] Juan Enriquez predicted in 2001 that "genomics" will compare to "digital" in global impact. No doubt, but on the way to the genome revolution isn't it hard to keep track of who is doing what and what is significant? The US FDA's actions last week represent just the kind of fluctuation that shifts the scene and changes the balance. Whether that's just for now or forever remains to be seen. The revolution's drivers have long been aware that the many subfields of genomics: consumer genomics, educational genomics, recreational genomics, genomics of ancestry, etcetera must be distinguished from medical genomics. While each category may be regulated (or not) by government, legal, economic or medical agencies in countries worldwide, I believe there is a way to cut to the chase and get on with the genome revolution. That's why yours truly focused on developing the commercial business model for genome applications, as illustrated in the YouTube Shop for Your Life!. The commercial business model offers the fastest growth and the most immediate consumer adoption, based on consumers' freedom of choice, with the least interference from lawyers, regulators and governments....but back to the US fracas and what is happening, or better said, not happening. I admire the legally precise analysis of Dan Vorhaus, who suggests that it may be a misunderstanding to think that "The FDA Cracks Down on DTC Genetic Testing". As he says, the Gutierrez letters (G-5) "may not be as significant". In fact, did FDA's Alberto Gutierrez "crack down" at all on DTC? There is no "cease and desist" order, no deadlines, no specific documentation to submit, but rather just the suggestion that there be a long brewing and largely ongoing dialog with the FDA. --doesn't sound like an enthusiastic endorsement of the genome revolution, but neither does it indicate the end of the U.S. version of the genome revolution. As he points out in his video, even the agency's director could re-think and update somewhat blurred definitions; i.e., what "medical device" may mean in the genomic age - a giant leap away from the 1976 mandate of FDA. Is it possible that the G-5 letters are just setting the stage for the widely heralded Congressional Investigation on DTC Genome Testing? Surely when Francis Collins, M.D., Ph.D., and Director of NIH, who wrote the book on Personalized Medicine, is called to testify before the Congressional Committee on Energy and Commerce, he can be expected to offer his specific recommendations from the NIH Genetic Testing Registry and could well suggest that registration be made mandatory, pursuant to an endorsement of the Congressional Committee. Note his initiation comments this March NIH Genetic Testing Registry. In the same spirit of educating the public through the political stage, the G-5 letters to Knome and Illumina may amount to invitations to two of the world’s pre-eminent genome R&D and industrial experts, Harvard Genomics Professor George Church, co-Founder of Knome, and Illumina CEO Jay Flatley to deliver Congressional Testimonies. With the nation watching, they could guide the Congressional Committee to bring the FDA into the genome revolution, or find/shape/create the agency or entity that will embrace it to the maximum benefit of the American public. Is it that the FDA has been remarkably passive for 3 years and now, with a Congressional Investigation imminent, feels the need to protect itself from all criticism that could suggest "it never flexed its muscles"? Sure, there was some muscle flexing when earlier G-3 letters seem to have scared Pathway Genomics away from DTC without resorting to anything that could be labeled "inappropriate regulation". The earlier Gutierrez salvo, G-3, was just a scary demand for a lot of documentation with a deadline so short there was no time for the Congressional Committee to act. Now, the G-5 may be entrée for participation in the genome revolution a la U.S. style with Congress dominant and the FDA retaining a scary innocence. So, let us watch the Congressional Committee conduct its eminently predictable hearings, and recommend appropriate legislation; through which "medical genomics" and "off-the-shelf genomics" (commercial and other non-medical utilization of information) should be clearly distinguished. We can be sure that if FDA is left to regulate Medical Genomics, it won't be the same FDA with the 1976 mandate Alberto Gutierrez notes in his video. This said, it is still possible that forces in the U.S. may be getting ready for the big "crack down", or even planning to kill DTC in the U.S, and diminish the country's status in our Genomic Age. In fact, they could manage a big set-back for the U.S. just by imposing a cumbersome legal agenda that takes so long the U.S. could miss its chance just by having to wait, all while DTC in Asia soars. We can hope that Congress will be well aware that there isn't enough money to address escalating health care (sick care) and listen to "We the People" demanding genome-based prevention. The Congressional Committee would be well advised to keep DTC business open during legal renovations through a moratorium on any further regulation of DTC until legislation puts the regulatory houses in order. If the U.S. does bow out or just misses the boat, I look at Asia as particularly conducive to the kind of commercial genomics I promote, which are based on a genome computing architecture that applies smart phones to empower consumers to exercise their freedom of choice using genome-based recommendations. Asia is advanced in both mobile computing and genomics already, and backed by their Big IT. The really good news is that the number of lawyers per capita is a fraction of the U.S.'s, and so is the cost of labor... more for the U.S. Congress to consider, and they had better do so quickly. Justifying DTC Genome Testing with Consumerism NOTE: The sequence of events and broad media coverage and commentary can be followed at HoloGenomics “News”. Background Events When Walgreens announced that it would sell Over-the-Counter (OTC) “Genetic Test Kits” from Pathway Genomics, a vague statement from an FDA spokesman ensued (see Washington Post article), and as a result retail chains suspended plans. Congress appeared alarmed by the news which seemed to suggest to them that genome testing was spreading from Direct-to-Consumer (DTC) to OTC. With the news, the FDA was stirred to the point of launching a Congressional Investigation into three DTC genetic testing companies. The current scene inspires us to look more closely at some facts: Walgreens planned only to sell “saliva-containers” on behalf of Pathway Genomics; Pathway Genomics has been selling its test online for years; This second wave of regulatory fervor over genome testing once again threatens to impede the US at a critical time in a global competition to access and apply personal genomes for individual use and self-determined control. Consumers must ask, “Whose genome is it, anyway?” Analysis of Status Quo It is universally accepted that consumers need access to products that support their lives. Though, the number of ingredients in single products and the complexity of assessing interactions and adverse reactions render making the best possible choice challenging, to say the least. The time calls for user-friendly automation of product recommendation and consumer choice, and the DTC genome testing model facilitates that outcome. For example, various consumer product companies provide products that contain lactose and/or gluten intended for those who thrive on these ingredients. The same companies may also provide comparable products with alternative ingredients for those who cannot metabolize certain substances (alcohol being another good example). An intolerance or adverse reaction is not a disease but a genomic measure of human diversity that can go undiscovered without genomic testing and cause some individuals considerable discomfort for many decades. HolGenTech software enables consumers to avoid incompatibilities and/or adverse reaction as they select goods and products through user-friendly automated product recommendations. It positions genome testing not as a replacement for any medicine, but simply as a tool to optimize wellness in the midst of the consumer experience at the point of the product encounter. We see this distinct and compelling consumerism use as a rationale that impeccably supports and justifies the DTC genome testing model as presenting no challenge to Medical applications. Let me crystallize this case and do it quickly. Otherwise, this present round of US regulatory fervor could lead to events setting back the domestic DTC genome testing industry just at a critical juncture, when some very sizable global competitors are moving rapidly to advance personal genomes throughout other countries and regions. In fact, off-shore competitors are exempt from US government scrutiny and yet able to compete in global markets, as should US-based DTC genome testing companies. The pure consumerism DTC model not only does not compete with the Medical applications, but it stands alone and in some contexts it can complement Medical models. Note HolGenTech in operation in one category of our business—genome-based, automated product recommendation: “Shop for Your Life”. As illustrated by the YouTube, HolGenTech provides consumer recommendations through smart phones, selecting products by ingredients best suited to consumers based on personal genomic raw data from the genome tests produced by DTC genome testing companies. This is not a replacement for a doctor or any kind of medicine, but rather a system optimized for genome-based product recommendations, so consumers can make optimal product choices while shopping. This use of DTC genome testing is non-threatening to the medical establishment, and could be readily advanced by leading DTC product companies that can significantly benefit from "genome-based product recommendations". Tools that empower the consumer to more precisely personalize their choices from the range of available products will create advantage with a new type of product and company loyalty. Consumers are likely to flock to the product company that first provides them with personalized product recommendations. DTC product companies, whether OTC or online, traditionally have not competed with doctors or medicine. An alliance of DTC Product Companies offering enhanced consumer benefit through DTC genome testing companies promotes consumers’ best interests. As consumers are empowered to make best possible choices for wellness from among a vast array of products and too many ingredients to review timely, the general public is directly served through economical and efficient DTC models. In the interest of the voters and taxpayers, we can hope US agencies will recognize the benefits for the public and advance the interests of the companies working very hard to bring personal genomic data to individuals for their practical use and consumption. The HolGenTech connecting technology illustrates how this is very effectively done . Future trends One can imagine and project how HolGenTech might eventually leverage DTC genome testing to offer advantages beyond the consumer and include Medical Doctors, Pharmacists, Genome Consultants, etc. with its technology developed entirely independent of the Medical domain. For instance, presently DTC gene testing can reveal sensitivity, effectiveness, and adverse reactions of a limited number of prescription medications; if medical professionals could rely on user-friendly automation based on personal genome data when prescribing/administering medicines, both the medical professional and the consumer/patient would realize even more benefits from DTC genetic testing. Very soon, DTC genome testing companies that currently use microarray technology for limited interrogation (up to 1.6 Million points) of DNA, will move to affordable full genome sequencing and broaden the scope of personal genome information and application (for the 12.4 Megabits of full diploid DNA information, with extended amounts of information how the DNA is functionally altered through epigenomic channels of e.g. environment, nutrition, etc). With the expected onslaught of affordable personal genomes (by leading molecular sequencing companies such as Complete Genomics, Pacific Biosciences, Ion Torrent), consumers should be poised and ready to use their personal genomes to make optimal choices to support wellness and longevity by avoiding individually harmful ingredients, in a consumer model free from regulatory fervor. HolGenTech presents a consumerism model that readily justifies DTC genome testing for the general population, as it leverages many interoperable factors-- existing health information, personal preference, and genome testing data for consumers to use automated recommendations in the shopping choices they make daily – nutrients, chemicals, body care and the full range of products for which one can shop in stores or online. HolGenTech clearly demonstrates the unique consumer advantages that DTC genome testing enables for consumers. Blog Comments (1): Last week Nestle, Deaken University, and GS1 Australia, were cited for developing an iPhone app that reads barcodes, so consumers suffering from allergies can shop intelligently for products that will not aggravate allergic reactions. As I noted last month (see Blog post of 3/10/10), P&G seems to be going well beyond Nestle with their lead investment in Navigenics and Personal Genomes, positioning for the ultimate in targeting consumers for healthy shopping. Nestle is being very smart and showing an edge, beginning now to leverage barcodes for meaningful data that can be determined now and personalized for a consumer from a product scan; i.e., allergic reaction. Though P&G would surely supersede with a tool ready to apply barcode readings relevant to personal genome data, Nestle is positioning well now with the right consumer tools. So far, P&G hasn’t exposed a defined plan for their investment in personal genomes. Companies like P&G and Nestle could revolutionize consumer product marketing through personalization targeting. Consumer product companies may soon be designing products that better utilize their bar codes and align with personalized medicine and consumer health awareness sites, like Microsoft Health Vault and Google Health. Rather than developing costly marketing materials, packaging and clever ads, these companies may better move to investment in highly targeted personalized approaches to shopping for health. Certainly, P&G has already made an investment that suggests they could personalize product lines or all products to target personal genome shoppers. We’ll see if they follow Nestle with their own consumer personalized shopping tools. When I introduced the concept of using a smart phone to shop with personal genome-based recommendations in June of 2009 at the Personal Genome conference in Boston, it was still at “concept” stage. We demonstrated the technology in January 2010 at the Personalized Medicine conference in Silicon Valley, basing recommendations on interoperating multiple factors, including user preference, known health conditions, and personal health data stored at Microsoft Health Vault and/or Google Health, and poised to incorporate personal genome sequencing data. HolGenTech, as a technology company, sees the value of dovetailing with a Nestle-type consumer product company to prepare consumers to use personalized, health-based recommendations in smart phone applications. HolGenTech’s Personal Genome Assistant (PGA) illustrates the ultimate in consumer value by taking the concept all the way to a recommendation engine based on personal genomes. How will P&G act on the opportunity? - Pellionisz_at_JunkDNA.com Comments (1): NPR [Excerpts only. For full text, see "original"] If anyone knows about DNA, it's physician-geneticist Francis Collins, director of the National Institutes of Health... So it was a natural move for him to ship off his own genetic code for analysis... When the results came, Collins, author of the new book , The Language of Life: DNA and the Revolution in Personalized Medicine, found what science said about his own DNA a bit unsettling... "It did affect me to find out that I was at risk for diabetes, which I had no family history of. But my family has all been extremely lean and I was not so lean, as I discovered when I got this information," Collins says. The "wake-up call" led Collins to switch up his diet and start an exercise program. His efforts helped him drop 25 pounds. Collins considers this type of personalization of medical recommendations as "part of the solution to the current confusion" over medicine. "You wouldn't go into the shoe store and just pick shoes off the rack without noticing if they were your size and yet, oftentimes with medical recommendations, that's kind of what we've had to do because it was the best information we had," Collins says.... "As we learn more about an individual's risk -- from family history to DNA testing to understanding environmental exposures -- we ought to be able to come up with recommendations that are more personalized," Collins says. "I think people are ready for that. I think they're hungry for that. I think they are more likely to be responsive to that. But we have a long ways to go in terms of preparing people for that kind of individualized approach to medicine." Blog Comments (1): Satisfying the Hunger for Personal Genomes and Accelerating the Genome Based Economy I’ve had the pleasure of meeting Dr. Francis Collins over the years and much appreciate his book The Language of Life. My own work in genomics, and particularly in personal genome analysis, interpretation and genome based recommendation, stirs me to add to the perspective Dr. Collins shares in his statement: "As we learn more about an individual's risk —from family history to DNA testing to understanding environmental exposures — we ought to be able to come up with recommendations that are more personalized. I fully agree that people are not only ready for that; I think they're hungry for it. I think they are more likely to be responsive to be given an automated choice. But we have to invest in individualized approaches to medicine." I’ve worked in the field of geometrization of neuroscience for decades, with my work overlapping with genomics since 1987. With the imminence of affordable personal genome sequencing, I believe the kind of personal genome application that Dr. Collins sees through his academic lens as still a way off could happen much faster. The peoples’ “hunger” noted by Dr. Collins entices an eager private sector to satisfy that hunger. One may recall that in his book, The Language of Life, Dr. Collins freely admits that personal genome developments have occurred much faster than he, or the genomic research community at large, had anticipated 10 years ago, or even 2 years ago! My optimistic expectation arises from my multiple areas of expertise. My background spans computer technology, biology, and physics, relating well to my genomics research and enabling me to recognize that genome computing will drive demand for personal genomes, because the right computing architecture can and will automate personal genomes for use in practical daily applications that everyone can adopt. As people realize they can automate decisions every day that can improve their health and well being, and all it takes is some hours of their time, the cost of a fine meal, and an application for their smart phone, we will have arrived in a veritable Genome Based Economy. While I am encouraged that Dr. Collins is at the head of the government’s NIH, I still don’t believe the government will drive the kind of genome application and mass adoption that Dr. Collins seeks and of which I speak. Remember, the internet was a government R&D project that only blossomed as the most lucrative Web under the tending of private industry. Developments from Pacific Biosciences and Complete Genomics that make personal genome sequences affordable are about to unleash a new dimension in data—personal genome data—and it’s an onslaught. All this DNA information presents a computing challenge, both at algorithmic and platform levels, and will inevitably mature to become the next frontier in computing that the private sector will exploit, much like the internet economy. Accelerating demand for personal genomes can be accomplished through genome computing and the right marketing. It is true that consumer interest in personal genomics could languish without the right tools to use personal genomes, but with the computing architecture to search the personal genome, analyze issues in the genome, and make recommendations as one proceeds to make daily decisions about waking, sleeping, eating, bathing, cosmetics, nutrients, exercise and anything at all…under the automated advisement of one’s own genome, I cannot think there will be any languor. As Dr. Collins also notes in his most recent book, Direct-to-Customer (DTC) models of prevention such as 23andMe and Navigenics, have limited their own possibilities by failing to empower customers with automated tools. This has proven to be a critical flaw in the present DTC business model. Customers of these businesses own their genome SNP (single nucleotide polymorphism) information, but they can’t use the long lists of digital information in practical daily application. The companies deliver marker analysis, usually in the form of a short list of observations or advice, and in raw data files suitable for automated use – but still lack the tools that enable consumers to act on the new information they’ve been given. Advice can be vague, and file information—while easily downloaded—is not easily interpreted for actionable use. So, DTC customers of today lack the power of their personal genome information in daily decision making. The DTC business model will continue to struggle until companies offer analysis, interpretation and recommendation that can impact their customers’ lives with some immediacy. Genome computing analysis and recommendation changes the whole model for driving personal genome consumption. By automating personal genome information to provide personal recommendations, while integrating other factors like family history, personal preference and known risks, genome computing satisfy the people’s “hunger” to which Dr. Collins refers. If there is such a hunger-- and I agree there is-- then setting out the banquet should produce a rush to the table. Andras J. Pellionisz, Ph.D, Founder of HoloGenomics, Inc. Why the State of Personal Genomics is Not as Dire as You Think [Article Blogged]
[The original posting is here, with the top diagram that is challenged by the blog replies and by the bottom diagram, by A. Pellionisz, explained by blog replies below- Pellionisz] Bob West says: Dan- add to your list of supportive arguments the current viability of at least several dozen (perhaps several hundred?) of additional PG companies that so far have been operating in stealth mode, including the likes of Counsyl and Pathway Genomics which are just beginning to get media attention. For every one that dies there will be three others to take its place. Great post! Bob Steven Murphy MD says: Dan, Counsyl is not exactly fully DTC. It partners with physicians and does a great job. I am certain the other SMART DTC companies will do the same. -Steve --- renatam says: Great post, Dan! --- Andras Pellionisz says: Four more substantial reasons why the future of Personal Genomics is bright: 1) Personal Genomics is a sine qua non of Personalized Health-Care. As health care system costs (in the US at the least) become unsustainable, P4 (Personalized, Predictive, Participatory Prevention, a coinage of LeRoy Hood) is already a disruption towards Personalized Health-Care, no matter what anybody says. 2) Those whose say actually matters a lot (chiefly, Francis Collins, M.D./Ph.D. Director of NIH) in his book totally endorses both the science and practice (even at his personal level) genome-based-prevention, with the book “top praise” as an official endorsement coming from Barack Obama. 3) DTC business models are currently limited both to microarray SNP-interrogation technology and operating in an “open loop” manner. Both are to change; migration from SNP-s to affordable full DNA analysis is under way, and the “open loop” where the consumer is not yet empowered to use their interoperable health- and genomic data, overridden by their personal preferences in their daily consumer activities, becomes a closed (“repeat customer”) business model. HolGenTech, Inc. changes this business model both via barcode-shopping by your genome, and via genome-based-web-recommendation of products and services, see YouTube 4) DTC has been mostly US-based (except for the initial DeCodeMe in Reykjavik, now reorganized after bankruptcy of Iceland). Just days ago, however, an ambitious Genome Testing Institute in Korea (see postings in “News and Blog” in HolGenTech.com) opened shop with SNP-based DTC, with the declared ambition not only to migrate ASAP to full DNA-based genome analysis, but becoming the world’s dominant business by extending beyond Korea to China and India. Personal Genomics is a global business – with the Beijing Genome Institute, Japan’s RIKEN (with 99% homogeneous Japanese population and extremely high incidence of Alzheimer’s), Hong-Kong and Singapore’s Genome Institute all sure to join the fray. Pellionisz_at_junkDNA.com [Full disclosure: Founder of Silicon Valley based HolGenTech, Inc.] --- Dan Vorhaus says: Steve: You are correct about Counsyl, which is one of the reasons why the post uses the “personal genomics” label, and not “Direct-to-Consumer (DTC) genomics/genetics.” DTC is part of, but not coterminous with, personal genomics. Companies such as Counsyl, Navigenics, DNA Direct and others are increasingly driving that point home, as well as helping to demonstrate the breadth of the personal genomics field. --- Dan Vorhaus says: Andras: While I don’t think DTC is limited to SNPs (see: Knome and Illumina, both of whom offer DTC components, albeit for the wealthiest of consumers) I think most agree that it is only a matter of time before SNPs are replaced wholesale with complete sequencing. The real question, then, is how and what services will be provided to consumers (and patients) that come in the door already in possession of a complete genome sequence. It may be that the “repeat customer” model you describe takes hold, but I actually envision more of a marketplace approach, based around a single interrogable dataset (the genome, and related inputs – health history, consumer preferences, etc.) with multiple entities striving to develop the most useful and/or interesting personal genomics services and/or applications. I also think your final point is an excellent one. To the extent that personal genomics is largely focused on the US market today, there’s little reason to expect that situation to persist over the long- or even medium-term. BGI’s massive Illumina purchase is, I would expect, just the tip of that iceberg. --- Andras Pellionisz says: Dan, I am delighted that you resonate so well to the “Globalization by Korea [Asia]“, in part because this breaking news went unintentionally (or intentionally?) relatively undetected in the heated debates in the USA. Points we are making in HolGenTech.com (news and blog) that Asia is much less slowed down by FDA-type regulatory issues, monopolistic for-profit-business of health care, collective societies are less concerned about individual privacy when it comes to efficacy, and in most of them health-care is centralized government-service (rather than for profit “sick-care” as Francis Collins puts it in his Personalized Medicine book). Regarding your wondering about the future business models, Asia also provides yet another interesting and highly significant aspect. “Mobile is Huge in Asia”. Thus, HolGenTech already received much interest from Asia, precisely because “tele-medicine” (not to use the strange term of “tele-health-care…”) is the most aggressively growing sector within Personalized Health Care (which is, according to PricewaterhouseCoopers, is the only 11% growth-segment in the USA, while the entire Chinese economy is growing with that rate). With the enormous distances in China and India (and the relative scarcity of hospitals compared e.g. to the US), “tele-P4″ is likely to play a faster growing and more prominent role even compared to our medicine – with the US already much slower in digitalization of health-data than comparables. As the Google phone already has 16 Gb memory (usual desktops come with 2 Gb…), one sees no reason why individuals should divulge e.g. their “personal preferences” to a cloud of any color, government server, etc., rather than keeping them encrypted within the awesome computer they carry (just because it doubles as a phone). Ultimately, it is also a question where the affordable full DNA sequences will reside. I daresay, that since they forever resided in our privates one may even want to “keep it that way” – in electronic storage tucked under our skin; for fast and private syncing under individual control – just as with natural DNA. I intentionally strayed into the future further than the usual “next quarter”. Those who will read Francis Collins’ fantastic book will find themselves in the same mindset “We are not in Kansas any more”… Pellionisz_at_junkDNA.com Steven Murphy MD says: Dan: I love it! Co-Terminous. What do most people think when you say Personal Genomics. Heck even the DTC companies said \Genomics finally gets personal\……. DTC Genomics is moving towards Consumer and Provider directed genomics. Which is just about the only thing that will keep this industry afloat for the next 10 years till we can figure out what most of this stuff does…… On a lighter note, did you see the FDA black box for Plavix 2C19 testing? This is where the field should be, NOT Ear wax… If it is medicine, say so -Steve --- Steven Murphy MD says: Andras, I completely agree. You are spot on. Asia is the market here and will be for the next 30 years. Imagine the help you could give people who have no hospital! Congratulations on your launch. Good Luck. --- Mr. Gunn says: I was just talking to a friend of mine yesterday who got a screening from Pathway Genomics at a pretty good discount, and they said, “It’s interesting, but the big downside is that you don’t get access to the raw data like you do with 23and me.” I wholeheartedly agree with his assessment. ---- Andras Pellionisz says: We are converging towards the HolGenTech business model – I would say with some obvious bias. Pathway Genomics provides actual advice – but does not reveal the raw SNP file, whereas 23andMe makes the raw file available (with hardly anyone downloading incomprehensible bunch of numbers), while puts the focus on the social aspects and tends to stay shy on specific advice. HolGenTech not only combines the advantages of both approaches, but provides Personal Genome Assistant (PDA serving as PGA) and Personal Genome Computer (PGA, any computer to start with, and migrating to HPC as the industry migrates both to analysis of full DNA analysis of COMPLEX structural variants, like fractal defects). As for the Plavix 2C19 testing, HolGenTech technology is eminently capable to moving to the pharmacogenomics market, but since it is a minefield of FDA regulation and medical establishment, will wait until they will be required, for economical reasons. The financial driver will NOT be Big Pharma (they are happy to sell any high-priced drug, effective or not…) – but when the pices are right it will be the Big Insurance that will require proof that the medication they reimburse is actually effective (for their own good). From HolGenTech’ viewpoint, we’ll just do very well on the unregulated “supplement market” and never pretend (use a disclaimer) that we rate one thing higher over another. We’ll just make “genome based recommendations” – just like the “past activity based recommendations” e.g. Google “sponsored ads” don’t pretend to pontificate what is better than something else. It is implied in e.g. Google “sponsored ads” that those products and services that can afford to pay for sponsored ads are economically doing better than their competitors (who can’t afford “sponsored ads” – thus may not be that good). “Survival of products that fits people’s genome better” – but personalized. But than again, we look at your genome, not your identity; providing “Personalization without getting personal”. Pellionisz_at_JunkDNA.com, Founder of HolGenTech, Inc. Korea moves to Genome Testing - Can US Execute on Critical Factors to Corral Personalized Healthcare Continuing on my theme of an imminent Genome Based Economy, I look at the news out of Korea and am compelled to send up a flare to US genome testing companies and their investors. Watch Korea; watch Asia! US companies like 23andMe and Navigenics have to feel the pressure as Korea’s Theragen Bio Institute takes the Direct-to-Customer (DTC) genome testing business model to a global scale. Theragen seems to be eyeing a world leadership position as the company targets ethnically homogeneous Asian countries, like Korea and Japan, as well as the world’s most populace, like China and India. Korea—and other Asian countries where healthcare is a matter of state control and funding—will not be impeded by government regulatory bodies, issues of consumer privacy, and an entrenched medical treatment infrastructure. Rather, government-based systems in Asian countries are likely to eagerly adopt and support DTC genome-based prevention healthcare for the obvious economic advantages that pertain when meeting the healthcare needs of their own countries’ populations. As well, these Asian DTC models can rapidly advance unencumbered and attract outside investment and more DTC users worldwide, as a result. Theragen Bio Institute, like 23andMe and Navigenics, initially will use microarray SNP-interrogation, but they clearly intend to move to full human DNA as personal genome sequencing becomes affordable. If these new players can move to the personal genome analysis that other DTC companies have not advanced toward, Asian DTC business may seize dominance over one of the greatest economic opportunities to come along since the internet boom of the 1990s. Considering the prevailing economic conditions and US issues that have challenged DTC businesses, Korea could forge ahead with relative ease, effect critical personal genome analysis, and set the standard in healthcare, personal genome business and IT. The US, the California DTC companies and their investors should seriously ponder the implications and prepare to act before the vast economic advantages move to other shores. Genome Service Available for Predicting Illnesses [in Korea and Asia] The Korea Times The company's service, "Hellogenom," decodes 1 million genome pairs per person. If a person sends a saliva sample in a kit, they will be notified on their susceptibility to 50 to 100 widely known diseases. "It tells whether a person has the genetic predisposition to develop diseases such as diabetes and some cancers among others," the company spokesman, Sung Se-hun, said. While the information isn't 100 percent reliable in defining whether a person will get a certain disease or not, it will allow them to pay extra attention to their health, he added. The institute's procedure will be supervised by Prof. Kim Sung-jin of Gachon University of Medicine and Science, who decoded 3 billion pairs of genomes in 2008. The company said reaching out for a wider use of the genetic information will come in the future. In Western countries, where large corporations are stepping in as investors, the information is used in finding people's heritage. Sung also said the technique could be used in verifying the identity of children reported missing or ethnic Koreans living overseas. However, he said the institute will focus more on providing health data. "We will lead the market, which is expected to mark 200 trillion won in 2015 worldwide. We are already seeing some positive signs for expansion into China, India and other Asian countries." Personalized Medicine and Procter & Gamble? Consumer Products and Genetic Testing? February 10, 2010, Silicon Valley Last week, Navigenics announced see here an $18 million dollar round of financing lead by consumer product giant P&G (Procter and Gamble). Navigenics is among the pioneers in the emerging Direct-to-Customer (DTC) personalized medicine category. P&G’s entry into the category suggests that your genome may begin to influence the products you buy every day. When Nathan Estruth, VP of P&G's FutureWorks says, "Personalized genetic testing can have significant meaning in helping consumers focused on prevention and wellness live better, healthier lives – something that P&G has always been committed to," I take notice and so should we all. From P&G’s investment and accompanying statements, it seems that consumers may soon have genome-based, highly personalized products from which to choose that promote the consumer’s drive to exercise prevention and wellness. Two weeks ago, at the Personalized Medicine World Conference 2010 see here, my new company HolGenTech, Inc. demonstrated the first Personal Genome Assistant (PGA) as part of an overarching genomic computing architecture to enable the consumer to take advantage of their personal genomes in every practical way. The simple shopping demonstration on YouTube, Shop for Your Life see here and embedded below, illustrates just how one might use a smart phone as a personal genome assistant (PGA) to incorporate their genome data, personal and family health history, personal experience and preferences into a shopping experience. Could the PGA very soon be applied to personalized genome based products that P&G or similar product companies may bring to market? We all can hope! For some time, I have suggested we are on the verge of a Genome Based Economy with products and services that are about to change the way we live. With companies like P&G stepping in and taking genomics testing from science to a business driven category, we may expect nutrients, cosmetics, household products, and other materials, to be offered for our consideration on the basis of our genomic proclivities and current state….and could it happen soon? Again, we all can hope! Product companies like Procter & Gamble could turn consumer marketing on its head. Not just developing marketing materials, packaging and expensive advertising to reach us, consumer product companies could be designing products that nourish our genomes. Our purchasing decisions could and should be based on what is good for each of us individually, not on one-size-fits-all recommendations of how to be healthy, or on search-based advertising or marketing hype that promotes impulse buying. P&G’s move into genomics is timely with the appointment of Dr. Francis Collins to head the government’s National Institutes of Health (NIH). Dr. Collins, who led the Human Genome Research Project through the 1990s to 2001, is a strong advocate of prevention in healthcare and Personalized Medicine. Dr. Collins just published a book, The Language of Life, upheld by the actress in the YouTube below, in which he very simply explains the state of Personalized Medicine and prepares the public for the new paradigm in healthcare. In it, Dr. Collins explains that an old belief system is passing away: “Your genome is not your destiny,” he says. The obsolete belief that your genome controls you has produced fear and skepticism that is replaced today with hope through empowerment that comes from understanding one’s best choices to affect one’s genome. P&G could be positioning to promote best choices based on the genome. Again, we all can hope! To date, Navigenics and other DTC companies have been considering a very tiny part of the genomic data, called SNPs (single nucleotide polymorphisms), in their services and reports. It is very exciting for the public to know and consider that we are within a short time (contingent on the volume of competitive funding) of both having access to very affordable whole genome sequencing, and thus genome-based choices for the masses. Whole genome sequencing provides a window into one’s complete genome, so interpretation of one’s genomic data, interoperable with one’s health data and personal preference, is already becoming possible with unlimited potential. Interpretation calls for an “informatics revolution in the 2010s” according to Eric Schadt, Chief Scientific Officer of Pacific Biosciences. It requires high performance computing, custom algorithms, and further break-throughs in science. As these –and now major consumer product forces– align, look for an acceleration of the present new chapter in Genome-Based Economy. As the new chapter of Genome Based Economy unfolds, the public can realize better medicine, better healthcare, wellness, prevention, and well-informed, highly personalized lifestyle choices. With access to and utility of our personal genome, consumers can experience personalized everything from healthcare to nutrients to clothing to housing and environmental choices, even to friends .... everything suited to our personal genome. A Genome-Based Economy ideally enables all the "right choices at the right time" and could engender longer, and certainly healthier, lives. Andras J. Pellionisz, Ph.D. The first Commercial full personal genome and SNP information service in Asia launched by Theragen Inc. in Korea From Genomics_org HelloGene: SNP chip based personal gene information service HelloGenome: Full genome based sequencing and information service The Genome Care Project was launched by Theragen BiO Institute led (Director, Jong Bhak). The price for the full personal genome service (Gold) is $200,000 USD. A standard version (Silver) is $150,000 USD. The price for a full personal SNP genome typing service (Premium) is $2000 USD. A standard version is $1000 USD. This service is the first commercial personal genome service in Asia. The Theragen BiO Institute (BiO institute) has analyzed the first personal Korean genome in Dec. 2008. The BiO institute researchers also participated in PASNP project that used 73 Asian ethnic groups using Affy 50K gene chips. The results of the first Korean genome (Dr. Kim Seong-Jin's) was published in May 2009 in Genome Research. The result of the PASNP consortium was published in Science magazine in Dec. 2009. The GenomeCare project is to map all the Asian ethnic groups for personalized medicine. [This twin-article, first as an early announcement in 2009 of intentions, and in March 2010 the actual start of the low-end (SNP-based) DTC service, is certain to shake-up DTC worldwide. First, DTC originated from DeCodeMe (Iceland), based on the pioneering R&D by Kari Stephansson. - but since Iceland went bankrupt, the company has just gotten reorganized. The leading US DTC companies (23andMe and Navigenics) had to break through rather stiff opposition of regulatory agencies (last summer the State of California issued a ban on genomic testing - only to be lifted in 6 weeks when KPCB "special partners" Colin Powell and Al Gore questioned if "prevention" was cheaper for the state budget than taking care of an avalanche of Alzheimer's and Parkinson's patients). The Great State of New York has only weeks ago lifted their ban - and only for Navigenics. In addition, the "privacy issue", paramount as is in the USA, handicaps not only Navigenics and 23andMe - but precludes even some formidable and most suitable "Big IT" from joining the fray. Lastly, the US population is probably the most "ethnically mixed" power, and DTC already bumped into the difficulty of interpreting even raw SNP results for customers with "mixed ethnicity". Asia will be completely different - and thus expected to take the lead in DTC sooner than the US is prepared for it. Korea, one of the ethnically most homogeneous country is already the trail-blazer, but the also highly homogeneous (and also gizmo-oriented) Japan are likely to expand the presently open-loop business model of DTC with "barcode-shopping" via the pervasively used "smart phones" that can help with personalized barcode-shopping. Singapore, while it has citizens of almost all countries of the world, is still about 72% Chinese - and thus can be the model how the simple "Caucasian or Asian?" boxes of US DTC can be made a whole lot more sophisticated. While in Korea or Japan most do not need a "genealogy genomic test" to start with (to see which SNP-interrogation custom-array needs to be used), non-Chinese in Singapore, and most of the US customers will first undergo a preliminary "genealogy genomic test" - and then the most fitting ethnic profile will be used both for testing for "structural variants" characteristic to the given ethnic group as well as the "barcode-shopping" recommendations will factor in the ethnicity. Fortunately for Asian countries where the interest of the society overrules the interest of individuals, neither the regulatory nor the privacy issues will erect the huge barriers we see in the USA - with the added advantage that in most of the civilized world health-care is a government service as opposed to a for-profit private industry. Prevention will be an incentive for governments to steer society towards avoidance of those diseases that are most burdensome for the society (e.g. Alzheimer's in the aging Japan). - Pellionisz_at_junkdna.com To post your blog reply, email HolGenTech_at_gmail.com |
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[view of DTC by pessimists]
[view of DTC by optimists]