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Like it or not, the possibility of money and profit drives science just like it does any other field. Therefore, it should come as no surprise that a few genetic testing companies have created DNA-based kits that purport to be able to predict the athletic capabilities of children and young adults. 

The kits developed by Australia-based Genetic Technologies (sold in the US by Atlas Sports Genetics) and CyGene Laboratories of Coral Springs, FL are based on variations or single nucleotide polymorphisms (SNPs) of the alpha actin-3 (ACTN3) gene that encodes a protein involved in actin development of muscle fibers in skeletal muscles. Atlas sells the kit for $169 whereas CyGene’s kit costs $100. 

Presumably, kids that possess the appropriate ACTN3 DNA sequences may be athletically more gifted than those who do not. As we scientists know, innate athletic ability is more than likely a multigenic trait and the presence or lack of a single DNA sequence or SNP cannot reliably predict a person’s future athletic potential. However, most parents who already have been sold on the power of personalized medicine do not! Again, it should come as no surprise that parents are buying these kits and testing their children to determine whether or not they ought to sign their kids up for pee wee soccer or T-ball at age 3! Perhaps, even more egregiously, is what may happen to the kids who test “negative” for ACTN? Will they be relegated to the bench (pardon the pun) for the rest of their lives? To wit, researchers at the University of Wisconsin-Madison (my alma mater) this week published a commentary in the Journal of the American Medical Association to disabuse parents that these tests are predictive of their children’s athletic ability or even worth the money they paid to purchase them!

Like these authors, I believe that the companies that developed the ACTN3 tests are clearly putting profits before science. There is no question that we have entered the “age of personalized medicine.” But, most personalized medicine tests are still not ready for prime time and companies that assert that it is are being deceptive or disingenuous at best. Similar sentiments were echoed by J. Craig Venter in an interview that I conducted with him which is published in this month’s edition of Life Science Leader. Like him or not , without Venter, the so-called age of personalize medicine would have likely been delayed by three to five years or more. Nevertheless, put simply, at its current stage of development, personalized medicine is clearly being oversold to the American public!

There is no question that real personalized medicine will be a reality in the next 5 to 10 years. hat said, we are simply not there yet. The fact that many genetic tests like ACTN3 are not regulated by the US Food and Drug Administration suggests that new regulations and over sight for them is desperately needed! Also, new initiatives must be created to improve the US public’s understanding of science—it can no longer be ignored as we continue our push into the age of personalized medicine!

Until next time...

Good Luck and Go Badgers!

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There is no question that DNA, genome sequencing and personalized medicine are on their way to becoming part of the American lexicon. While most Americans haven’t a clue as to what these words mean, many have jumped on the “DNA bandwagon” because of television shows like CSI and its derivatives and high profile genetic information companies like 23 and Me, which was co-founded by Anne Wojcicki a Yale undergraduate biology major and wife of Google founder Sergey Brin.

Countless numbers of Americans have sent DNA samples to be analyzed by 23 and Me and other genetic information companies to learn about their ancestry and possible health implications contained in their genetic codes. Although the technologies used by these companies may not be ready for prime time-use for personalized medicine purposes, they are scientifically sound and relevant. Imagine my surprise when I read about a company called DNA11 that promises to create customized art from a person’s DNA. Yup, you heard me correctly—a customized DNA portrait! 

Here is how it works. Customers send a cheek swab (DNA sample) to the company and they sequence it. Then, a personalized DNA portrait is constructed from the code. Clients get to choose the color and size of the portrait and can also elect to have up to four person’s DNA added to it! And the best part is that it only costs $199 (starting price)! Of course, DNA samples are marked with anonymous codes and are supposedly destroyed after portraits are rendered.

DNA 11 is the brain child of Nazim Ahmed a former DNA imaging salesperson and Adrian Salamunovic a web designer. I have to admit that I thought the idea was a cool one! But, then again, I am a geeky scientist and the transformation of science into art is an intriguing proposition! Also, if positioned correctly, DNA11 could help to promote scientific literacy in the US.

The company has been featured in the New York Times, Wired Magazine and others on “The View” CNBC and the Discovery Channel. Moreover, both Nazim and Adrian have reportedly made millions and their products were recently featured on a recent CSI episode. Recently, the company announced that a portion of its revenue will be donated to charity. Nevertheless, I can’t imagine that, these days, most lay people have enough disposable income on hand to spend it on a less-than-useful DNA portrait. That said, I have been known to be wrong in the past. And, I have learned over the years that anything is possible in America--not that there is anything wrong with that!

Until next time...

Good Luck and Good Genetic Profiling!!!!!!!

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The US Food and Drug Administration (FDA) announced on Friday that it will begin monitoring and investigating the services offered by consumer-focused, personal genomic testing companies. In warning letters to five companies, the agency notified company executives that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies have submitted their products for approval, according to the FDA. Further, the agency contends that personal genomic tests as medical devices must be “analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations." Previously, the agency hadn’t definitively classified the tests as medical devices. However, the agency has become increasingly concerned that results from the tests may ultimately be used for diagnostics and prognostic purposes by various entities including insurance companies and employers.

The companies that received letters on Friday included California-based 23 and Me (backed by Google Health), Navigenics and Illumina and Knome of Cambridge, Mass.; and deCode Genetics of Lake Barrington, Ill. The FDA sent a similar letter in May to Pathway Genomics of San Diego, after Pathway announced it intended to sell its tests through Walgreens drugstores. Many industry insiders believe that the proposed Pathway Genomic-Walgreens was the proverbial “straw that broke the camel’s back” which prematurely forced the agency to take regulatory action.

The letters deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc. FDA asks each of the companies to contact the agency to make arrangements for submitting their tests for review. 23andMe and Navigenics and DeCode Genetics, sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting certain diseases like cancer or diabetes. Illumina sells DNA chips that are used by some companies to do the DNA scans whereas Knome offers consumers a complete sequence of their DNA, which can be used to glean disease risk information. While 23 and Me is pushing back, deCode Genetics CEO stated that the company will work with the agency to legitimize its tests as part of “standard medical care.” Knome, whose whole genomic sequencing platform will ultimately supplant the services offered by 23 and Me, Navigenics and Pathway Genomics, has also expressed a willingness to work with the agency.

Despite the existence of theGenetic Information Nondiscrimination Act (GINA) enacted in May 2008—which ostensibly would shield patients from potential “genetic discrimination”—many privacy and medical information advocates fear that loopholes will allow insurance companies and prospective employers to abuse the results from personal genomic analyses. To that end, GINA does not cover life, individual disability insurance, or long-term care insurance, and the potential for genetic discrimination still exists in these areas. For example, a person at genetic risk for developing Alzheimer’s could be denied long-term healthcare insurance because Alzheimer’s patients have been known to live for long periods of time, and their care is costly.

Another legitimate concern raised by some people is ownership of the results of personal genomic analyses. Surprisingly, at present, it isn’t clear who owns or ultimately controls a person’s genetic information data after it is generated. For example, it is likely (but not certain) that a consumer who purchases whole genome sequencing services from a personal genomics company owns and controls his/her sequence data. Ownership and control of the information isn’t likely to be straightforward or easily defined until rules and regulations are crafted to clarify how genomic information is owned, stored, and accessed by individuals and third parties.

While companies like 23 and Me and their ilk aren’t pleased that FDA has finally classified their tests as medical devices, they had to know that regulatory oversight of the personal genomic testing business was inevitable. This is because the results from personal genomic tests have been and will continue to be used by various and sundry entities a diagnostic and prognostic tools.

It is obvious to almost everyone in the life sciences industry that there are huge sums of money to be made in the personal genomic testing space. Consequently, the last thing that personal genomics company executives wanted was regulatory oversight by FDA (it tends to interfere with business and profit margins). However, we all have experienced first hand what happens when companies are allowed to operate in the absence regulatory oversight.

Hat tip to FDA for finally taking a stand on this important issue!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Advances made in DNA sequencing technology and genomic analysis has lowered the cost of sequencing a genome from millions of dollars a decade ago to less than $500 today. And, because of this, there are a growing number of companies that are willing to quickly and cheaply sequence and analyze your DNA. While this may be medically beneficial and appealing to some, it may not be for everyone. Moreover, and perhaps more importantly, who will control access to and insure the privacy of your genetic information if you choose to have your genome sequenced and analyzed. 

Alan McHughen, PhD, a molecular biologist and Professor of Botany and Plant Sciences at the University of California-Riverside, who has previously written about privacy and access to personal genomic data, wrote an article for BioJobBlog that explores the ramifications and possibility of DNA identity theft in the future. Also, he has written a book 'Pandora's Picnic Basket; The Potential and Hazards of Genetically Modified Foods' to refute the myths and explore the genuine risks of genetic modification technology

Genetic Privacy

By Alan McHughen

For just $399 (plus shipping and handling), the scientists at 23and me.com will scan your complete genome. The DNA analysis reports on 118 different medical and health dispositions, your maternal and paternal ethnic ancestry, and a curious bunch of genetic trivia concerning your persona (is your earwax sticky or flaky?). All you do is pay the money and spit into a collection tube; they extract your DNA from the spit and look for half a million single nucleotide polymorphisms (SNPs) scattered throughout your genome, including many in or near genes associated with particular traits. Other companies offer similar services. For example, Decodeme.com charges $985, but catalogs twice as many SNPs, and you collect your DNA with a cheek swab.

Alternatively, if you don’t need the complete genome scan but are curious about specific medical conditions or family lineage, you can get less expensive gene tests from an increasing number of companies willing to take your money and DNA sample in exchange for the genetic information their scientists reveal. If heart disease runs in your family, you may either relieve or exacerbate your anxieties by shelling out $200 to have a cardio scan for relevant genetic predispositions. Or, for as little as $99, a man can have his Y chromosome probed to confirm his place in the family patrilineage, and possibly connect to ancient and famous princes or pirates.

These genetic information services, with prices now well into recreational and hobby budget range, provide the most personal, private — and unchangeable— information possible about you. The sinister side of this fascinating field is all too often overlooked—it can reveal your most intimate genetic details to strangers and nosy neighbors. While the various testing labs assure confidentiality, there is little to no control over personal genetic information. In the US, anything you discard is salvageable by anyone else, and your trash can become another’s treasure if it carries blood, saliva, hair, semen or any other DNA-laden bodily secretions.

While we worry about identity theft, personal financial or other private information, our uniquely personal information is up for grabs. The Genetic Information Nondiscrimination Act (GINA) of 2008 offers some protection, but it is limited to employment and medical insurance issues. GINA does not protect your genetic information from being abused by life insurers. Or nosey neighbors. 

Genetic privacy raises a whole spectrum of social, ethical, legal and medical issues. Suppose your neighbor salvages your trash and has your DNA analyzed. This local gossip then shares the juicy news that you have a “higher than average predisposition” to, say, alcoholism. Soon, everyone in the community shuns you as a latent alcoholic, and you have no idea why. The community knows more about your genetic makeup than you do. And, because they don’t know how to interpret statistical language such as “a higher than average predisposition”, those conditions may easily be exaggerated into probabilities, if not certainties.

If people have a right to know their own genetic information, they have the obverse right to NOT know. People can choose to remain ignorant about their genetic makeup. Consider, for example, Huntington’s disease (HD). This death sentence is one of the few health conditions almost due to genetics, and the DNA assay has been available for years. Curiously, most people at risk, i.e., those with HD in their direct lineage, choose NOT to take the test; they prefer not to know until (or if) symptoms appear. What happens when the local busybody lets the cat out of the bag on HD? Word will get around and the at-risk person will inevitably find out, if only by the ‘different’ treatment by neighbors, thus obliterating the exercise of their right to remain ignorant. Whether the test result is positive or negative on HD is immaterial at this point, the rights will have been violated. The DNA test for HD is currently more elaborate than the simple SNP analysis, but because SNPs associated with HD are being reported, it’s only a matter of time before they come generally available.

Perhaps you’ve suspected the woman down the street had a child from an adulterous one night stand a few years ago, and the cuckold husband remains a doting, if clueless, dad. Now, with just $89 (including overnight FedEx delivery!) and a little misdemeanor creativity, well within the standard ethical bounds of busybodies, you can satisfy your suspicions with a surreptitious and discrete paternity test. And, to provoke some real excitement in your sleepy small town, show the results to the husband.

A few minutes of thought and discussion generates many other issues and examples of the precarious security of personal genetic information and identity, and the potentially dire consequences of genetic information getting out. Society is yet to discuss the privacy issues surrounding genetic identity as vigorously as we have with personal financial or medical records. It’s getting late. Do you know where your DNA is?

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In his book, “Free: The Future of a Radical Price” Chris Anderson, editor of Wired Magazine, asserts that the cost of DNA sequencing falls 50% each year. To that end, in February, a company called Complete Genomics based in Mountain View, California, announced it will read entire human genomes at $5000 a shot, starting in June this year. This will cost less than one-tenth of what companies charge today for genome sequencing. 

If you believe Anderson, in five years sequencing a human genome will be under $100. Based on these calculations, the window of opportunity for companies that sequence genomic DNA to make a profit is closing rapidly. So, if you were considering getting into the DNA sequencing biz, the right time may be now—before it is no longer a profitable biz model.

Until next time...

Good Luck and Good Sequencing!!!!!!!!!!!
 

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The long sought after cow genome has been sequenced. Heralded as a milestone in animal genetics, unraveling the cow genome will provide scientists with “tantalizing clues to explain the essence of bovinity.” Two papers describing the results of the project will appear in today's issue of the journal Science. 

The cow who donated its DNA for sequencing was a Hereford named LI Dominette 01449 and is one of the estimated 94 million bovines in the US. The project, led by researchers at National Institutes of Health and the U.S. Department of Agriculture, was a gargantuan effort that spanned six years and involved more than 300 scientists from 25 countries and cost only $53 million. Based on sequence analyses, cows haver 22,000 genes as compared with 20,000 to 25,000 for humans. Some of the other findings include: 

• Cattle and humans have about 80 percent of their genes in common

• The organization of human chromosomes is closer to that of domestic cattle than to those of rats or mice, which are often used in lab tests of drugs intended for people.

• Cattle chromosomes, like those of humans and other mammals, contain segmental duplications, which are large, almost identical copies of DNA present in at least two locations in a genome.

• In domestic cattle, there are duplications related to immunity, metabolism, digestion, reproduction and lactation. Such duplications in humans have been related to a variety of disorders.

Researchers hope that elucidating the bovine genome will help them find ways to improve milk and meat production, develop new strategies to treat and prevent diseases and to reduce the carbon foot print of cows that release large amounts of greenhouse gases that contribute to global warming.

Great news to receive on National DNA Day! 

Science rocks.

Until next time...

Good Luck and Good Job Hunting!!!!!

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A panel of eight judges at the Wharton School of Business at the University of Pennsylvania was asked to identify the top 20 life-altering technologies that were developed over the last 30 years. The survey was sponsored by Knowledge@ Wharton, U Penn’s business publication and the PBS’s “Nightly Business Report.” 

Not surprisingly, the Internet was voted the top innovation followed by computers, mobile phones and e-mail. Interestingly, DNA sequencing and testing was listed as number 5—one of five technologies from the life sciences and medical sectors—the others being MRI, laparoscopy, genetically-modified plants, biofuels and anti-retroviral (HIV) drugs. Finally, Internet social networking, a recent innovation, made a surprise appearance on the list at number 20!. The entire list is as follows:

1. Internet, broadband, WWW (browser and html)
2. PC/laptop computers
3. Mobile phones
4. E-mail
5. DNA testing and sequencing/Human genome mapping
6. Magnetic Resonance Imaging (MRI)
7. Microprocessors
8. Fiber optics
9. Office software (spreadsheets, word processors)
10. Non-invasive laser/robotic surgery (laparoscopy)
11. Open source software and services (e.g., Linux, Wikipedia)
12. Light emitting diodes
13. Liquid crystal display (LCD)
14. GPS systems
15. Online shopping/ecommerce/auctions (e.g., eBay)
16. Media file compression (jpeg, mpeg, mp3)
17. Microfinance
18. Photovoltaic Solar Energy
19. Large scale wind turbines
20. Social networking via the Internet
21. Graphic user interface (GUI)
22. Digital photography/videography
23. RFID and applications (e.g., EZ Pass)
24. Genetically modified plants
25. Bio fuels
26. Bar codes and scanners
27. ATMs
28. Stents
29. SRAM flash memory
30. Anti retroviral treatment for AIDS

If your favorite technology wasn’t listed in the Top 30, please let me know and we can add it to the list!

Until next time...

Good Luck and Good Job Hunting (try social networks)!!!!!!!

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Researchers at the ARC Centre of Excellence for Kangaroo Genomics (KanGO), including University of Melbourne, ANU, WEHI, University of Sydney, University of UNSW and the Australian Genome Research Foundation (AGRF) announced today (yesterday in Oz) that they have built a framework to assemble the genome of a model kangaroo, the tammar wallaby.  DNA sequence data obtained by the Australian Genome Research Facility (AGRF) with funding from the Victorian government will be arranged using the genome map.

KanGO Director Prof. Jenny Graves said “Australia’s weird and wonderful animals are making crucial contributions. The kangaroo has helped to consolidate Australia’s reputation in this important genomics era,” More importantly the map and DNA sequence may open up new areas of research into how genes are turned on and off during development of all mammals.

Those Aussies…you gotta love ‘em!

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Who can resist those adorable black and white Giant Pandas? Late last week, the International Giant Panda Genome Project was launched by Beijing Genomic Institute-Shenzhen, China. The goal of this project is to finish the sequencing and assembling of the draft sequence within six months. 

According to the news release:” The giant panda is a much loved animal all over the world and is considered a symbol of China, as illustrated by its being one of the mascots for the upcoming Olympics in Beijing. The excitement surrounding the launch of this ambitious project, however, has been built around how this new genomic information will have extensive impact in numerous scientific areas -- from ecology to evolution to sequencing technology. Such data will aid in understanding the genetic and biological underpinnings of this unique species, especially with regard to its very specific niche in the environment and the molecular mechanisms of its evolution.”

“Of special interest is that these data will be extremely useful for protecting and monitoring this endangered species and will provide information on the impact of captive breeding. In addition, it will have considerable use in controlling diseases that could devastate these fragile populations.” For those of you who don’t know, breeding pandas is not an easy thing. In fact, according to a guy I used to work with, who is a panda breeding expert, it is more art than science. However, it may not be as arcane as he makes it out to be considering that he had a sweet consulting gig for panda breeding with the Chinese government.

The giant panda project (GPP) will be conducted by Chinese scientists as well as scientist from other countries including, Canada, Wales, Denmark and the United States! It is truly an international collaboration!

Long live the pandas!

Until next time…

Good Luck and Good Job Hunting (try GPP- China)!!!!!!

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