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Navigenics, Inc. was a privately held personal genomics company, based in Foster City, California, that uses genetic testing to help people determine their individual risk for dozens of health conditions. Wikipedia.

The present disclosure provides methods and systems for assessing an individuals genotype correlations to a phenotype by analyzing the individuals genomic profile and using ancestral data to determine the correlations between genotypes and phenotypes.

Navigenics | Date: 2013-12-13

The present disclosure provides methods and systems for personal action plans based on an individuals genomic profile. Methods include assessing the association between an individuals genotype and at least one disease or condition and providing rating systems for an individuals action plan. Incentives to motivate and encourage people to improve their health and well-being are also disclosed herein.

News Article | April 21, 2012
Site: venturebeat.com

The cost of sequencing the human genome continues to fall, reaching a low of $1,000 this year due to a new microchip and machine designed by genetics company Life Technologies Corp. And unleashed by those lower costs, a small cadre of entrepreneurs in Silicon Valley is exploring ways to harness this data to enable us to live longer and healthier lives. Dr. Dietrich Stephan, a human geneticist, has spent the better part of a decade trying to achieve that goal. Until recently, it has been costly and time-consuming to map the 3 billion units of DNA, known as base-pairs, which make up the human genetic code. But now, he said, with the low cost of gene sequencing technologies, we are on the brink of banishing a one-size-fits-all approach to medicine. “Every disease has a genetic component, and yet largely none of the available genetic information is being used today to treat patients,” he said. Genome sequencing had been limited to a select few. Biographer Walter Isaacson claims the late Steve Jobs had his DNA sequenced for $100,000 after being diagnosed with pancreatic cancer. To biotech entrepreneurs, bringing gene sequencing to a mass market is the most exciting development since the completion of The Human Genome Project. According to Joe Betts-Lecroix, a biophysicist and entrepreneur, that major international undertaking was expected to yield a map of the mutations that cause disease. Instead, genetics researchers found that the genes only seem to account for a tiny percentage of inherited traits and differences between a healthy and sick person. “The Human Genome Project was a monumental achievement, but also a huge disappointment,” said Betts-Lacroix, who recently delivered a rousing TEDx SF talk on using genetics to cure aging. “It’s not about the human genome, but more the human gene pool. To really understand what’s going on, we’ve found that we have to sequence the DNA of millions of people. This work is only beginning, and will require much lower-cost sequencing. Fortunately, that seems to be upon us,” said Betts-Lacroix. At a select few hospitals across the country, the work has already begun. In 2010, the Children’s Hospital in Boston recruited Dr. Dietrich Stephan – a biotech entrepreneur fresh from the success of Sequoia-funded genetics startup Navigenics – to join the Gene Partnership Initiative, one of the first efforts to gather genetic information about disease. Relying on his experience as a biotech entrepreneur, Stephan developed the hospital’s first sustainable program to sequence the genomes of 100,000 young patients. The program is still ongoing, and researchers are finding links between genes, the environment, and complex genetic disease. Already, the flood of genetic information is being used to produce drugs that are better targeted to patients. Not everyone processes medicine in the same way; by understanding patients’ genomic make-up, doctors can provide a therapy they’ll respond to best. That’s an important capability considering that this year alone, close to 800,000 people were injured or died due to adverse reactions to drugs. “With the knowledge we have now about your genes, we are finding ways to diagnose sick people earlier and develop medicines to zap the core defect,” said Stephan of the Gene Partnership Initiative. Biotech entrepreneurs predict that the low-cost of gene sequencing technologies will yield new approaches to the treatment of cancer and other diseases by 2015. With this in mind, Stephan has delved into clinical diagnostics with a new startup, Silicon Valley Biosystems. With his latest venture, he said the goal is to “get fancy IT into the hands of physicians so patients can benefit from it.” “It’s no longer business as usual in medicine,” he said. Patients will be “touched and informed by genetics” in the next 2-5 years, meaning that hospitals will increasingly adopt gene-sequencing technologies to better treat and diagnose disease. Sabah Oney, business development lead at SVBio, said we’ll see common diseases being re-branded as we better understand their root cause. “Instead of diagnosing breast or lung cancer, physicians will refer to the disease by its genetic abnormality.” The major challenge facing genetics entrepreneurs is to take the concept from the lab and turn it into a commercial product. “The rate of failure discourages many investors,” said Mohsen Moazami, founder and general partner of Seif Capital, an early stage venture capital firm focused on health and bio-sciences. “But there’s no question in my mind that for a subset of companies that crack the code on this effort, the opportunity is immense,” he added. The startup that firmly put the spotlight on genetics is 23andme, which provides insights on your future and ancestral past based on a DNA sample. This month, the company hit a new milestone: 150,000 users. 23andme does not sequence the entire genome. Instead, it determines through genotyping whether users are at risk of developing particular diseases. Genomic sequencing is the future, but 23andme boasts a vast database of genetic information. “This data is driving a whole new wave of discovery in terms of genes and environment. The real meaning will become clear in the next few years,” said Dr. Uta Francke, senior medical researcher for 23andme. This year, 23andme has participated in research to understand how the body will react to certain medications. Francke recalls a recent study of how a female user in Australia discovered through the test that she was highly averse to anesthesia. “She may not have woken up. Some of these people say 23andme has saved their life,” said Francke. “We think there is evidence that when people know their genes they take their health more seriously,” Francke added, although she did not point to supporting research. She suggests that users should print out their information and take it to their personal physician for advice about taking actionable steps to improve their health. Critics of 23andme say that when this information is placed directly into the hands of consumers, very few choose to adjust their lifestyle accordingly. It took several years for 23andme to attract 100,000 users. WellnessFX, a San Francisco-based health and wellness startup, is among the first to leverage human health data to prevent the onset of disease. The company’s target market are people who want to remain in peak physical health for longer. These users can access a visual spectrum of both genetic and biological data. The idea is that data is only meaningful when it’s used to make recommendations to improve general health. Users are re-tested at regular intervals to chart improvement. “We show users that if they change their lifestyle and nutrition, they will see measurable results in a finite period,” said Jim Kean, chief executive officer of WellnessFX. Individuals can log in to explore a colorful display of their data at any time; Kean calls it a “personalized health dashboard.” Innovation on the genetics data front has moved at a glacial pace and has yet to hit a mainstream market. But startups like SVBio, Knome, Illumina, and Navigenics have succeeded in raising awareness about how data can improve public health. This March, the Obama administration showed its support with a $200 million grant for industries that can benefit from “Big Data.” With the increased availability of human data, it’s no surprise that the National Institute of Health (NIH) received the lion’s share. As part of this initiative, the world’s largest set of data on human genetic variation was uploaded on Amazon Web Services cloud (AWS) and is available to all researchers. Betts-Lacroix, a serial entrepreneur working with startups like Halcyon Molecular to develop advanced DNA-sequencing technologies, said this open data will precipitate a gold rush for genetics research. As he puts it: “There are discoveries just waiting for people to find them, no lab work required.” Christina Farr is a Bay Area-based writer with a graduate degree from the Stanford School of Journalism. She covers entrepreneurship, technology, and investment trends. Christina works for, but does not speak for, Eastwick, an agency in Silicon Valley.

News Article | April 15, 2013
Site: venturebeat.com

Should human genes be patented? The Supreme Court is weighing in today in a landmark case,  Association for Molecular Pathology v. Myriad Genetics, Inc., 12-398., that will have an enormous impact on the future of science, technology, and medicine. At the center of the debate is Utah-based Myriad Genetics. Scientists at the biotech company discovered two genes — BRCA 1 and BRCA2 — that are associated with hereditary breast and ovarian cancer. Since then, it claims its tests have been used by more than one million women to determine if they have an increased risk of developing these cancers. The company patented these discoveries — the “synthetic molecules we isolated and created in the lab to provide life-saving tests,” the company’s CEO explained in an op-ed in USAToday. But Nobel Prize-winning geneticists argue that the patent will stifle research and medical diagnostic testing. Because of its patents, Myriad can prevent other researchers from testing, studying, or even looking at these genes, and it also holds the exclusive rights to any mutations along those genes, according to the American Civil Liberties Union (ACLU). The U.S. patent system’s rules stipulate that you can’t patent a product of nature or a law of nature, even if research took years and proved costly. For this reason, Albert Einstein did not patent the law of relativity. A parallel can be made with a rare East African plant, which has a variety of medicinal uses. It might be plausible to patent a drug that comes from the plant, but it would be unreasonable to patent the plant. “Over the past 20 years, at least 41 percent of our genes have become the intellectual property of corporations,” genomics professors Christopher E. Mason and Jeffrey Rosenfeld argue on the ACLU’s blog. “These patent claims contradict an intuitive sense that our DNA is no less ours than our lungs or kidneys,” they continue. The ACLU also claims that the patent has allowed Myriad to charge patients exorbitant rates for its test. Until recently, the medical profession largely shunned patents. A favorite quote that has been liberally used by Myriad’s opponents is from Dr. Jonas Salk, who invented the polio vaccine. Rather than file a patent on the vaccine, he reportedly said, “There is no patent … could you patent the sun?” Human geneticist Dietrich Stephan says he’s been following this debate closely since 2006. Stephan is the cofounder of Navigenics, a genetics diagnostics company acquired by Life Technologies Corp. in 2012. Stephan agrees with the ACLU, and is concerned that patenting genes will be detrimental to patients. “You should be able to give patients gene sequencing information that will benefit their health,” he said in an interview. “Patents may prevent that.” According to Stephan, the likelihood of the Supreme Court siding with Myriad Genetics is low. Myriad will still own the brand and have the highest-precision test in the market. So even if three competitors emerged tomorrow, Myriad will still out-perform in sales. “Even so — competition is a good thing,” he asid. Collaboration is another issue as many of these genes will be used together to form the basis of a test — “more and more it’s not a single gene that is diagnostic,” said Stephan. Efrat Kasznik, an intellectual property lecturer at Stanford University, said the patent system offers inventors a limited monopoly (20 years from filing) in return for public disclosure for their innovation. But not every finding can be patented. Similarly to a mathematical equation, the Supreme Court may rule that our human genes can never be owned. Dietrich Stephan will speak at HealthBeat, VentureBeat’s upcoming healthcare and innovation conference in San Francisco on May 20-21.

News Article | April 18, 2013
Site: www.wired.com

The business of DNA is undergoing a revolution. We can already get our genes scanned for the bargain-basement price of $99. Soon we’ll be able to have entire genomes sequenced for less than the cost of a MacBook Air. That’s huge considering that not so long ago it cost billions of dollars to map a single genome. But the ability of scientists, doctors and companies to tell us how our genes might impact our health now hinges on a case being debated by the U.S. Supreme Court, the infamously drawn-out Association for Molecular Pathology v. Myriad Genetics. The case dates back to a 2009 lawsuit filed by the American Civil Liberties Union and centers on the question of whether genes — those snippets of DNA that encode the proteins inside cells — can be patented. The ACLU and the scientists, advocacy organizations and patients it represents say no because a gene is something that exists in nature, just like a leaf, an oxygen molecule or gold. Myriad Genetics told the Court its inventors had created a new, never-before-seen molecule. Some of the justices don’t seem to buy Myriad’s argument, sparking some hope in the genomics and personalized medicine communities that when the Court finally decides the case — probably in late June — they’d have reason to celebrate. “What we’re arguing about is really the future of medicine and either accelerating it or slowing it down,” says Dietrich Stephan, the CEO of SV Bio and founder of Navigenics. “[Gene patenting] turned into this quagmire that was holding the field back. “We need to be able to instantaneously deliver that information to [patients] and their doctors and not go through all these crazy hoops of paying the license holder.” The real value and potential for innovation, experts say, comes after genes or gene mutations are identified, and that genetic insight is then applied to a new process, method or algorithm. In most cases, those new processes, methods or algorithms would still be patentable, but not the underlying genetic code. Diagnostic and therapeutic companies would compete on the quality and price of their tests instead of having a monopoly on the entire pipeline, as Myriad does now with its patents on BRCA1 and BRCA2, two genes associated with early-onset breast and ovarian cancers. Women who want to be tested for these genes have to take Myriad’s test, which can cost several thousand dollars. As it stands now, the patent-happy U.S. Patent and Trademark Office has doled out thousands of gene patents since the early 1980s, many of which cover human genes. Myriad Genetics is not the only organization that holds these kinds of patents. 23andMe, Incyte Genomics, Genentech, Harvard, MIT and the University of California are but a few of the institutions that have held or continue to hold gene patents. Some of the patents don’t require licensing fees and are pretty open. Others are locked up tight. Run afoul of the wrong gene patent, and you can expect a lawyer to get involved. Myriad has sent researchers cease-and-desist orders and Harvard and MIT have filed lawsuits. All of which hampers the progress of scientific research, says Rochelle Dreyfuss, a professor at the New York University School of Law who specializes in intellectual property law and science. “In order to do a full sequence for a person, you might have to get permission from all of them,” says Dreyfuss.”That’s a lot of different people, and any one person could just say no.” That defeats the purpose — and potential — of whole-genome sequencing, and in a way, robs patients of their right to know their own genetics, a point the Association for Molecular Pathology has made in the past, says Dreyfuss. Their argument is that people have a First Amendment right to know the information inside their own bodies, but “the courts have never ruled on that issue,” she said. Like the pharmaceutical industry, Myriad and others argue that without the ability to patent genes, patients might be worse off. Lacking financial incentives, companies might not be willing to put in the years and millions of dollars it can take to make these kinds of advances, a point some of the Justices seemed to recognize this week. Whether that’s true or not is debatable. “In the drug space, people have very clearly figured out that the most airtight patents are around the molecules themselves,” says SV Bio’s Stephan. “Even if that molecule targets a gene, no one would argue that you’d need to have the gene patented in order for that patent to stand on its own.” We should take that model and apply it to diagnostics, he says, where the patentable discoveries are not genes, but new test kits that probe for genetic conditions or predispositions to certain diseases better and faster than previous technologies. That’s how you foster innovation and how you assuage the field that the market is going to be okay, Stephan argues. Whatever the Court decides this summer, one thing is clear: this case is only the beginning of the debate around who owns what genetic information, says Stanford’s Drew Endy, a bioengineer and an advocate of open-source biotechnology. In the future, scientists, doctors, companies and lawyers will have to grapple not only with gene sequences, but “what you can use the sequence to do.” That, he says, takes us into the brave new world of genetic copyright law, and if the music and software industries have taught us anything, it’s going to be a very long, uncomfortable ride.

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