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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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Previously, BioJobBlog reported on the race between two groups led by the Mars and Hersey companies to sequence and decode the cacao (chocolate) tree genome. It should come as no surprise that the world’s two largest chocolate companies have pitted themselves against one another to decode the wonders of the cacao bean. After all, chocolate is big business and learning how to maximize yields, improve flavors and optimize the levels of cacao bean chemical components would be a boon to the company that was able to obtain the genetic information first!

Currently, most cacao farmers earn about $2 per day, but producers of fine cacao earn more. Increasing the productivity and ease of growing cacao can help to develop a sustainable cacao economy. The trees are now also seen as an environmentally beneficial crop because they grow best under forest shade, allowing for land rehabilitation and enriched biodiversity. Today, many growers prefer to grow hybrid cacao trees—rather than the original variety Theobroma cacao, Criollo)—that produce chocolate of lower quality but are more resistant to disease. Roughly five percent of the world’s current cocoa production is derived from Criollo cacao beans because of increased susceptibility to fungal diseases which results in higher costs and lower yields.

At the last installment of this ongoing saga, the Mars group, September 2010, released a statement that that they had beat the Hershey group and unraveled DNA sequence of the most common cacao bean variety that is used to manufacture most commercial chocolate.

The Mars researchers constructed a preliminary genomic map that covered over 70 per cent of the total cacao bean DNA sequence which is distributed over 10 chromosomes. These data were uploaded to The Cacao Genome Database which is publicly available as long as persons who access the data sign an agreement that stipulates that they “will not seek any intellectual property protection over the data, including gene sequences contained in the database. The Information Access Agreement allows any cacao breeders and other researchers to freely use the genome information to develop new cacao varieties.”

While the Mars group may have beat the Hersey group to the popular press, their research has not yet appeared in an academic journal for scientific scrutiny. Interestingly, the Hersey group yesterday announced that their version of the cacao genome was published in the most recent edition of Nature Genetics. According to the authors,

We sequenced and assembled the draft genome of Theobroma cacao (Criollo), an economically important tropical-fruit tree crop that is the source of chocolate. This assembly corresponds to 76% of the estimated genome size and contains almost all previously described genes, with 82% of these genes anchored on the 10 T. cacao chromosomes.

Analysis of this sequence information highlighted specific expansion of some gene families during evolution, for example, flavonoid-related genes. It also provides a major source of candidate genes for T. cacao improvement.

While Theobroma is often used to manufacture gourmet chocolates that particular variety of cacao tree often remains vulnerable to disease. Information gleaned from this study could be used to breed bioresistant varieties of Theobroma.

Further the authors noted:

Our analysis of the Criollo genome has uncovered the genetic basis of pathways leading to the most important quality traits of chocolate--oil, flavonoids and terpene biosynthesis […] It has also led to the discovery of hundreds of genes potentially involved in pathogen resistance, all of which can be used to accelerate the development of elite varieties of cacao in the future.”

Other genes that were identified include those for the production of cocoa butter, natural antioxidants, hormones, pigments, and aromas. BTW, for those of you who may be interested, cocoa was thought to be domesticated about 3,000 years ago in Central America; making it one of the world’s oldest domesticated tree crops.

It isn’t clear yet how the cacao genomes deciphered by the Mars and Hersey groups match up against one another. Regardless, the big winners here are chocolate lovers. What to you think the world stance will be on genetically engineered chocolate? 

Oy!

Until next time...

Good Luck and Good Eating!!!!!

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Yesterday, Genzyme announced it would cut about 1,000 jobs worldwide as part of a restructuring plan. In addition, company spokespersons indicated that the company may outsource some of the eliminated permanent position and impose a hiring freeze. As part of its restructuring plan, the company plans on eliminating about 10 percent of its 12,800-employee workforce by 2012. It is unclear how many of the 4,500 US employees will lose their jobs.

In addition to the job cuts, the company announced that it had agreed to sell its diagnostic testing unit (reproductive and genetic testing) to Laboratory Corp of America for $925 million in cash. Henri Termeer, Genzyme’s beleaguered CEO also announced that the company’s other two units, molecular diagnostics and pharmaceutical ingredient manufacturing on also on the block and will be sold.

While Termeer insists that the job cuts and sale of non-core business units has nothing to do with Sanofi-Aventis’ attempt to purchase the company, many analysts believe that these measures are being taken to induce Sanofi to sweeten its $69 per share takeover bid. The additional monies garnered from the layoffs and division sales, will allow Genzyme to strengthen its stock position and bolster its cash reserves to defend against a possible hostile takeover attempt by Sanofi. 

The demise of Genzyme, once one of the most highly regarded and ethical biotechnology company in the world is directly linked to manufacturing problems at its Boston-based facility. The ongoing and protracted quality problems at the plant resulted in a consent decree by the US FDA and penalties totaling about $175 million. As most quality experts will tell you, systemic quality control and assurance issues generally stem from a lack of commitment to quality by senior management; in this case Termeer! 

Despite repeated request for his resignation, Termeer, who has run Genzyme for the past 25 years or so, has steadfastly refused to relinquish his post. Instead of stepping down to save the company, Termeer has chosen to “take the ship” down with him; the sure sign of an out-of-touch CEO who apparently was willing to sacrifice the reputation and worth of a company for entirely self-serving reasons.

Until next time...

Good Luck and Good Job Hunting

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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 the February issue of Genetic Engineering and Biotechnology News, J. Leslie Glick a former CEO of Genex and veteran of the biotechnology industry put forward a novel solution to financial crisis that is currently gripping the life sciences industry and the rest of the US economy. Dr. Glick proposed that the US government ought to consider injecting taxpayer monies into venture capital firms (VC) which, he believes, would foster creation of new companies, create more jobs, stimulate the ailing economy and also provide the government with an outstanding return on its investment.

According to Dr. Glick, “historical results reported by the National Venture Capital Association for the 20 year period ending December 31, 2007, show an annualized return of 16.7% to investors in some 1,860 U.S. venture capital and private equity partnerships. If the U.S. government had made annual investments of $10 billion in VC firms throughout the U.S. during that 20year period, the $200 billion total investment would have yielded a total return of almost $1.5 trillion.” Further, he asserts that according to the  International Trade Administration of the Department of Commerce, from 1970 to 2000, U.S. VC firms invested over $270 billion in more than 16,000 companies. In 2000, the surviving VC-backed companies employed 7.6 million people, representing 5.9% of all U.S. jobs, and generated sales of $1.3 trillion, accounting for 13.1% of the U.S. GDP.

This financial upside sound enticing but who is going to keep track of the money and keep an eye on how and what the VCs are investing in? Dr. Glick proposes creation of a non-partisan funding mechanism, possibly overseen by an independent panel of business people that would disburse $10 to $25 billion annually of taxpayer’s dollars to vetted and certified VC firms. Because of its investment, the US government would become a limited partner in these firms and could direct them to invest in technologies that would help to reduce health care costs, develop energy alternatives or improve food production capacity. While this proposal is unprecedented and controversial, we are living in extremely uncertain financial times that may necessitate innovative and out-of-the-box solutions to restore normalcy to the US economy. That said, all proposals—no mater how unconventional or outrageous—ought to be carefully evaluated and vetted to determine whether or not they have merit to help overcome our deepening recession.

Kudos to Dr. Glick!

Until next time,

Good Luck and Good Investing!!!!!!

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This month Kevin has reviewed an eclectic bunch of websites. Continuing with his “down under” theme from last month, Kevin offers the Australian National Herbarium and the Darwin Correspondience Project websites (okay so Darwin was English but he did visit Australia!). The Darwin site complements an interesting site called the Origin of Life Prize (check it out).  

Another Australian website called the Sea Snake Homepage covers everything you ever wanted to know about sea snakes (and then some) but as Kevin put it may not be for everyone. There is a technical site called Microscope-Microscope.org which has some terse but valuable information on well—microscopes.

My personal favorite is the Biomedia Associates Educational Biology site. Although it is a commercial site, it is an education website and offers some valuable resources for biology teachers and students.

Until next time…

Good Luck and Good Surfing!!!!!!!!

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Have you ever felt like mixing up a few batches of DNA in your  spare time? Well, for those of you who sometimes get the urge I found an easy-to-use recipe to make your own custom designed DNA sequences. Of course I was joking about doing it at home but if you happen to be at the University of Wisconsin-Madison Biotechnology Center you can give it a whirl.

Of course, the ability to build DNA sequences nucleotide-by-nucleotide has been available for over a decade or more.  That said, the relatively simple system devised by scientists at the UW Biotechnology Center allows even the neophyte molecular biologist to do it successfully.

Until next time…

Good Luck and Good Genetic Engineering!!!!!!

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