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	<title>InVitae</title>
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		<title>Genomic Information Wants To Be Free &#8212; New York Genome Center, 1/31/13</title>
		<link>http://invitae.com/main/new-york-genome-center-covers-randy-scotts-talk-at-pmwc/</link>
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		<pubDate>Fri, 01 Feb 2013 22:17:20 +0000</pubDate>
		<dc:creator>agianola</dc:creator>
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		<description><![CDATA[Kat McGowan &#124; January 31, 2013 We’re moving from a world of genetic scarcity to one of genetic abundance, said InVitae CEO Randy Scott at the 2013 Personalized Medicine World Conference in Mountain View, Calif., on Wednesday. It&#8217;s a transition<span class="ellipsis">&#8230;</span><div class="read-more"><a href="http://invitae.com/main/new-york-genome-center-covers-randy-scotts-talk-at-pmwc/">Read more &#8250;</a></div><!-- end of .read-more -->]]></description>
			<content:encoded><![CDATA[<h2><strong style="font-size: 13px;">Kat McGowan | January 31, 2013</strong></h2>
<p style="text-align: justify;">We’re moving from a world of genetic scarcity to one of genetic abundance, said InVitae CEO Randy Scott at the 2013 Personalized Medicine World Conference in Mountain View, Calif., on Wednesday. It&#8217;s a transition that will soon overturn the business model of the diagnostics industry, as well as the legal and regulatory frameworks built around it.</p>
<p style="text-align: justify;">Instead of a series of individual genetic tests for different conditions, Scott predicted, the test of the future will roll everything into a single assay: a whole genome sequence. Market forces and technological change are converging to accelerate this change, and Scott, who has been top executive at several genomic industry companies over the past two decades, predicted that 2013 will bring an inflection point where this kind of personalized medicine finally starts to become cost-effective.</p>
<p style="text-align: justify;">Often described as rare diseases, genetic disorders collectively affect between 20 and 30 million Americans, Scott pointed out. Currently, multi-gene panel tests for complex disorders cost thousands of dollars, so clinicians typically order single-gene tests instead, which run about $1,500. That price point is about to be eclipsed, said Scott. InVitae is now beta-testing a panel that tests for 270 genetic conditions for roughly the same price. The company plans to release the test this year, and gradually expand it to include the entire “Mendeliome”&#8211;all 2,000 or so Mendelian hereditary disorders, in one single next-generation sequencing assay.</p>
<p style="text-align: justify;">Delivering on the promise of personalized medicine will require annotating and curating all the data that are already available. “We need to organize all the world&#8217;s clinically relevant information,” Scott quipped. InVitae is now building a database that includes 24,000 clinically relevant variations and more than 440 genetic conditions that are already fully curated.</p>
<p style="text-align: justify;">In this future, companies that recognize the need to share will thrive, predicted Scott. He described a recently-launched “Free the Data” movement in which like-minded clinical labs can share variant information to improve the overall quality of gene-disease associations. The diagnostics sector needs to come to the same realization as the information technology world did before it, said Scott, and recognize that &#8220;information wants to be free.&#8221;</p>
<p>Link: <a title="http://nygenome.org/blog/genomic-information-wants-be-free-says-randy-scott-pmwc" href="http://nygenome.org/blog/genomic-information-wants-be-free-says-randy-scott-pmwc">http://nygenome.org/blog/genomic-information-wants-be-free-says-randy-scott-pmwc</a></p>
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		<title>InVitae Gearing up for Launch of Multi-Gene Targeted Sequencing Test for Inherited Diseases &#8212; Genomeweb, 1/30/13</title>
		<link>http://invitae.com/main/genomeweb-pharmacogenomics-reporter-features-invitae/</link>
		<comments>http://invitae.com/main/genomeweb-pharmacogenomics-reporter-features-invitae/#comments</comments>
		<pubDate>Fri, 01 Feb 2013 22:17:11 +0000</pubDate>
		<dc:creator>agianola</dc:creator>
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		<description><![CDATA[Turna Ray &#124; January 30, 2013 InVitae, a company specializing in using targeted next-generation sequencing to diagnose rare genetic diseases, is preparing to launch this year a $1,500 test to assess 270 inherited conditions. Randy Scott, former Genomic Health executive<span class="ellipsis">&#8230;</span><div class="read-more"><a href="http://invitae.com/main/genomeweb-pharmacogenomics-reporter-features-invitae/">Read more &#8250;</a></div><!-- end of .read-more -->]]></description>
			<content:encoded><![CDATA[<h2><strong style="font-size: 13px;">Turna Ray | January 30, 2013</strong></h2>
<p style="text-align: justify;">InVitae, a company specializing in using targeted next-generation sequencing to diagnose rare genetic diseases, is preparing to launch this year a $1,500 test to assess 270 inherited conditions.</p>
<p style="text-align: justify;">Randy Scott, former Genomic Health executive chairman and InVitae CEO, said at a personalized medicine conference here this week that the company is currently beta-testing this offering with a select group of physicians, anticipating a commercial launch of the test in the coming months.</p>
<p style="text-align: justify;">Genomic Health last year spun out InVitae, combined it with the genome annotation firm Locus Development, and took a minority stake in the joint entity (PGx Reporter 8/15/2012). In the future, Genomic Health has the option to increase its investment in the firm.</p>
<p style="text-align: justify;">InVitae&#8217;s platform gauges germline mutations associated with 270 conditions, particularly those linked to inherited cancers. Following the initial launch of the testing service later this year, InVitae hopes to update the offering every six months with an additional set of genetic tests, Scott said at the meeting.</p>
<p style="text-align: justify;">When Genomic Health decided to launch InVitae as a subsidiary last year, some industry observers questioned the company&#8217;s decision to focus on rare genetic conditions. &#8220;When we first started talking about these sorts of opportunities a lot of people said rare diseases are rare and you really should be focused on common diseases,&#8221; Scott said. &#8220;In fact, the whole concept of common diseases is an oxymoron. There is really no such thing. Diseases are common because there are multiple ideologies that drive the commonality and all diseases are rare diseases.&#8221;</p>
<p style="text-align: justify;">InVitae estimates that nearly 100 percent of the population carries mutations linked to rare genetic conditions. &#8220;We just don&#8217;t know which ones, but our families are nonetheless at risk for those rare genetic conditions,&#8221; Scott said. Moreover, he highlighted that between 30 million and 40 million people in the US are suffering from an undiagnosed genetic condition.</p>
<p style="text-align: justify;">&#8220;Genetic testing is one of the largest markets in the world,&#8221; Scott noted. &#8220;And our goal at InVitae is to bring genetics to the masses.&#8221;</p>
<p style="text-align: justify;">Keeping this in mind, InVitae is building its business infrastructure to deliver its tests to patients on a global scale. The company is in the process of building its first laboratory outside the US, so it can develop and market tests in different countries according to local regulations.</p>
<p style="text-align: justify;">&#8220;This is a global business. The US is 0.3 out of 6 billion on the planet. We&#8217;re actually a minor player in this game,&#8221; Scott said. &#8220;By having international labs you can then release information comprehensively on a country-by-country basis depending on local [regulations].&#8221;</p>
<p style="text-align: justify;">Scott wouldn&#8217;t elaborate on the lab or its location until its official opening later this year. However, he explained that the international lab is necessary to comply with the unique legal, regulatory, patent, and other restrictions for a particular region. &#8220;For example, our international lab will not be subject to US-specific gene patents in order to better serve ex-US markets on a country-by-country basis where gene patents don&#8217;t apply,&#8221; he noted.</p>
<p style="text-align: justify;">In developing its commercial testing service, InVitae also began building its own database of gene-disease associations. The firm aims to establish &#8220;one of the world&#8217;s best curated databases of clinical variation,&#8221; according to Scott.</p>
<p style="text-align: justify;">For three years, the company&#8217;s researchers scoured the literature to identify the various genes associated with a host of Mendelian disorders, and then documented the clinical evidence on the disease-linked markers. InVitae now has more than 440 fully curated genetic conditions and a database of more than 24,000 clinically relevant variants.</p>
<p style="text-align: justify;">While the data the company collects in its curated Mendelian clinical variants database will remain proprietary, InVitae is planning to share data on clinical variants that come out of commercial testing as part of a grassroots movement called &#8220;Free the Data.&#8221; While there is currently no formal structure to this project, there are number of participants, including labs at Emory University, Partners Healthcare, and the University of California, San Francisco, that are similarly minded and are sharing gene variant data in this manner.</p>
<p style="text-align: justify;">&#8220;Free the Data is targeted toward making clinical variants identified in the course of commercial genetic testing available for use by other clinical labs. InVitae plans to release variants of clinical relevance identified in our clinical laboratory during routine testing to the public as part of good medical practice,&#8221; Scott told PGx Reporter. &#8220;Other corporate information, R&amp;D and proprietary databases and algorithms that go into developing our clinical assays will be maintained as proprietary InVitae R&amp;D information.&#8221;</p>
<p style="text-align: justify;">Labs participating in the Free the Data initiative are doing so in an effort to improve the collective knowledge of all healthcare stakeholders – doctors, industry players, and academic researchers – on gene-disease associations. This is exactly the kind of effort that some industry observers have been pushing for, noting that as advanced genomic technologies become more integrated into mainstream care, the number of variants with unclear or unknown associations to disease will increase.</p>
<p style="text-align: justify;">&#8220;In industry we want to horde information and … not share it, but I think the companies that succeed in the future of this genomics revolution will be willing to share information and begin to put together a global marketplace for how we&#8217;re going to share and utilize this information with everybody,&#8221; Scott said at the meeting.</p>
<p style="text-align: justify;">In a recently published paper in the European Journal of Human Genetics, Duke University&#8217;s Robert Cook-Deegan and others wrote about molecular diagnostic firm Myriad Genetics&#8217; decision to stop publicly sharing its BRCA variant data linked to breast and ovarian cancer and keep that information as part of a proprietary database of gene-disease associations. By keeping this variant information a trade secret, coupled with its extensive patent suite, Myriad is denying researchers, physicians, and patients access to &#8220;basic scientific and medical information&#8221; that would improve their knowledge of variants linked to cancer and enable more accurate diagnoses,&#8221; the study authors charge (PGx Reporter 11/2/2012).</p>
<p style="text-align: justify;">They recommended in the paper that national health systems, government-run databases, and scientific journals require companies to share the variant data so that their tests can be independently validated. A less severe alternative would be if disparate players in the healthcare sector came together on their own to share data, as seems to be happening through Free the Data and some other efforts in the same vein</p>
<p style="text-align: justify;">&#8220;The published literature is often several years behind new genetic discoveries and many newly discovered variants may never be published. Some genetic conditions may have hundreds, even thousands of variants with newly discovered variants a frequent occurrence,&#8221; Scott told PGx Reporter in discussing the Free the Data effort. &#8220;By agreeing to share clinical variants, every lab benefits in helping patients and physicians to get the best information on whether a particular variant has been seen before and whether it may have medical significance.&#8221;</p>
<p style="text-align: justify;">Finally, when launching a new medical product on the market, physician education and engagement will be critical to growing test adoption. In this regard, InVitae is planning to build an online portal through which doctors can learn about and order tests. The company has launched a test catalogue that will soon be updated to reflect all 270 diseases that the test addresses.</p>
<p style="text-align: justify;">&#8220;We&#8217;re setting up networks of physicians who feel empowered to use this information on behalf of patients,&#8221; Scott said. &#8220;So we&#8217;re moving from a world of genomic testing to a world of genome management.&#8221;</p>
<p>Link: <a title="http://www.genomeweb.com/clinical-genomics/invitae-gearing-launch-multi-gene-targeted-sequencing-test-inherited-diseases" href="http://www.genomeweb.com/clinical-genomics/invitae-gearing-launch-multi-gene-targeted-sequencing-test-inherited-diseases">http://www.genomeweb.com/clinical-genomics/invitae-gearing-launch-multi-gene-targeted-sequencing-test-inherited-diseases</a></p>
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		<title>InVitae Aims At Wide Range of Genetic Diseases &#8212; San Francisco Business Times, 1/18/13</title>
		<link>http://invitae.com/main/article-on-invitae-published-in-san-francisco-business-times/</link>
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		<pubDate>Fri, 18 Jan 2013 20:18:27 +0000</pubDate>
		<dc:creator>agianola</dc:creator>
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		<description><![CDATA[Ron Leuty &#124; January 18, 2013 In Randy Scott&#8216;s world, parents are tested for hundreds of diseases they could quietly carry within their genes, children&#8217;s diseases are discovered early enough for treatment, doctors order those tests easily and the results feed<span class="ellipsis">&#8230;</span><div class="read-more"><a href="http://invitae.com/main/article-on-invitae-published-in-san-francisco-business-times/">Read more &#8250;</a></div><!-- end of .read-more -->]]></description>
			<content:encoded><![CDATA[<h2><strong style="font-size: 13px;">Ron Leuty | January 18, 2013</strong></h2>
<p>In <a href="http://www.bizjournals.com/sanfrancisco/search/results?q=Randy%20Scott">Randy Scott</a>&#8216;s world, parents are tested for hundreds of diseases they could quietly carry within their genes, children&#8217;s diseases are discovered early enough for treatment, doctors order those tests easily and the results feed into a wider circle of knowledge.</p>
<p>That world actually is here &#8212; now &#8212; says Scott, the founder of InVitae Corp., a San Francisco company beta testing a panel of 150 genetic conditions that can be uncovered by matching their gene variants in individuals. By the end of the year, Scott said, the assay will test for some 500 diseases.</p>
<p>InVitae&#8217;s assay costs about $1,500, Scott said. Single-gene tests for an individual disease, meanwhile, can cost $100 to $3,000.</p>
<p>&#8220;We&#8217;re offering 150 for roughly the same price as a single-gene test,&#8221; said Scott, the founder and former CEO and chairman of molecular diagnostics pioneer <a href="http://www.bizjournals.com/profiles/company/us/ca/redwood_city/genomic_health_inc/15421">Genomic Health Inc.</a></p>
<p>A wide-ranging test at that price could spell doom &#8212; or at least a transformational moment &#8212; for traditional testing centers, like those operated by Laboratory Corp. of America and Quest Diagnostics, Scott said.</p>
<p>What&#8217;s more, InVitae&#8217;s one-time test could deliver a diagnosis earlier and direct patients to clinical trials that aim at finding a treatment or cure for rare and everyday maladies. <a href="http://www.bizjournals.com/sanfrancisco/blog/2011/05/batten-disease-stemcells-illumina.html">Some ultra-rare, fatal diseases have been tough to research</a> because children often aren&#8217;t diagnosed until it&#8217;s too late to include them in a trial.</p>
<p>&#8220;It&#8217;s really an unmovable force now. The costs are driving this down. Generating information will make this a commodity business,&#8221; he said. &#8220;But it&#8217;s what you do with the information&#8221; that is important.</p>
<p>InVitae, <a href="http://www.bizjournals.com/sanfrancisco/blog/biotech/2012/02/genomic-health-randy-scott-genome.html">formed last year</a>, is jumping in at the right time, Scott said. Sequencing technology is allowing faster, richer and cheaper peeks into the genetic reasons why our bodies move or break down the way they do.</p>
<p>&#8220;We&#8217;re really trying to ride the tech wave,&#8221; said Scott, who will speak at the <a href="http://2013sv.pmwcintl.com/program.php" target="_blank">Jan. 28-29 Personalized Medicine World Conference in Mountain View</a> on bringing comprehensive genetic testing into routine medical practice.</p>
<p>Genomic Health has led the way in putting the technology into action. It initially focused on certain genes that can predict whether a mastectomy and chemotherapy prevents breast cancer from recurring. It expanded that work with an 18-gene colon cancer test in 2010 and, later this year, prostate cancer.</p>
<p>Now Scott and his InVitae team, backed in part by Redwood City-based Genomic Health, are looking at a lot of problems at once.</p>
<p>&#8220;Every one may be a rare disease, but together they&#8217;re quite common,&#8221; Scott said. &#8220;We&#8217;re all carriers.&#8221;</p>
<p>InVitae in August closed a $29.6 million funding round, which included <a href="http://www.bizjournals.com/profiles/company/us/ct/stamford/thomas_mcnerney_%26_partners/1199788">Thomas, McNerney &amp; Partners</a>, Genomic Health and himself. (Genomic Health has a 20 percent stake.)</p>
<p>The company has about 40 employees at its South of Market offices.</p>
<p>InVitae is aiming the test at doctors and consumers, but it also could have some real-world clinical trial applications as well. Drug developers may be able to find patients with ultra-rare disorders, for example, that haven&#8217;t yet displayed symptoms.</p>
<p>&#8220;We&#8217;re not trying to discover new markers,&#8221; Scott said. &#8220;We&#8217;re just starting from what we know about inherited diseases today.&#8221;</p>
<p>InVitae has a database of 25,000 known genetic mutations, Scott said.</p>
<p>In the end, he said, doctors can order one tests or all of the tests, but they can have a wealth of information available.</p>
<p>&#8220;If we found a patient with a severe medical condition and a variant, we really want to get that out there so doctors can cross-reference that,&#8221; Scott said.</p>
<p>Link: <a title="http://www.bizjournals.com/sanfrancisco/blog/biotech/2013/01/randy-scott-invitae-genomic-health.html?ana=RSS&amp;s=article_search&amp;utm_source=twitterfeed&amp;utm_medium=twitter&amp;page=all" href="http://www.bizjournals.com/sanfrancisco/blog/biotech/2013/01/randy-scott-invitae-genomic-health.html?ana=RSS&amp;s=article_search&amp;utm_source=twitterfeed&amp;utm_medium=twitter&amp;page=all">http://www.bizjournals.com/sanfrancisco/blog/biotech/2013/01/randy-scott-invitae-genomic-health.html?ana=RSS&amp;s=article_search&amp;utm_source=twitterfeed&amp;utm_medium=twitter&amp;page=all</a></p>
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		<title>InVitae Goes ‘All-in’ For Genomic Diagnostics &#8212; Xconomy, 1/18/13</title>
		<link>http://invitae.com/main/invitae-featured-in-xconomy/</link>
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		<pubDate>Fri, 18 Jan 2013 18:12:43 +0000</pubDate>
		<dc:creator>agianola</dc:creator>
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		<description><![CDATA[Luke Timmerman &#124; January 18, 2013 You could call Randy Scott an E.F. Hutton for the genomics business. People listen when the co-founder and former CEO of Genomic Health talks. And Scott isn’t just talking. He’s gone “all-in,” putting his<span class="ellipsis">&#8230;</span><div class="read-more"><a href="http://invitae.com/main/invitae-featured-in-xconomy/">Read more &#8250;</a></div><!-- end of .read-more -->]]></description>
			<content:encoded><![CDATA[<h2><strong style="font-size: 13px;">Luke Timmerman | January 18, 2013</strong></h2>
<p>You could call Randy Scott an E.F. Hutton for the genomics business. People listen when the co-founder and former CEO of Genomic Health talks. And Scott isn’t just talking. He’s gone “all-in,” putting his time, and a significant amount of his own money, into a new San Francisco company called InVitae. The plan is to develop a kind of dream diagnostic test that would have been quite unrealistic a couple years ago.</p>
<p>“We want to aggregate all the world’s genetic tests into a single assay, for less than the cost of a single assay today,” Scott says. He adds: “It’s kind of outrageous, but it’s eminently doable.”</p>
<p>InVitae—which is Latin for “in-life” and pronounced In-VEE-tay—has stayed stealthy in its early days. But that’s changing this year, as the company has gotten certified to run a central diagnostics lab and it’s gearing up for its initial commercial push.</p>
<p>The company, which combined assets last year from Redwood City, CA-based Genomic Health (NASDAQ: GHDX) and Locus Development, has pulled in $37 million to date from investors that include Genomic Health, Thomas McNerney &amp; Partners, and Scott himself. Scott started moving in this direction back in February, when Genomic Health formed InVitae as a new subsidiary with him as CEO. Six months later, in August, he jumped ship completely for the new company, resigning his Genomic Health board seat. InVitae, which took in $30 million of investment in November, has grown quickly to assemble a team of 40 employees.</p>
<p>“Having done startups before, I’m a big believer that you’ve got to be all-in,” Scott says. “If you want to start something from scratch and compete in today’s world of healthcare, it should consume 150 percent of your time.”</p>
<p>The goal of InVitae, in its early days, is to help geneticists to look broadly for rare, inherited genetic disorders (aka Mendelian disorders). There are thought to be about 1,500 of these rare conditions, which are often hard to diagnose. Sometimes these diseases prompt what Scott calls “medical odysseys” and are only diagnosed after physicians take stabs in the dark by running existing single-gene or multi-gene tests that can only answer narrow questions, and cost several hundred dollars apiece.</p>
<p>InVitae’s plan is to start small, and build from there. While the usefulness of information from consumer-oriented genetics companies (23andMe, Navigenics) has long been questioned in the medical community, InVitae has instead focused on looking for the small number of genetic abnormalities and variations that are clearly linked to a disease that physicians treat.</p>
<p>InVitae can’t yet run a comprehensive screen of all 1,500 Mendelian disorders, and deliver a report that definitely says whether a patient has one. It has spent its early days establishing a central diagnostics lab, equipped with Illumina sequencing machines, and combing through publicly available scientific literature to find the strongest links between genetic abnormalities and medical disorders. So far, for the small group of beta customers, the test can scan for 150 of those disorders, at a price of $1,500. If a physician wants to ask a narrower question—like whether a patient has one of the many genetic variations that lead to cystic fibrosis—the sequencing service and price can be tailored accordingly, Scott says. The samples get sent in to InVitae’s lab, and a report comes back to the physician a few days later.</p>
<p>While a huge amount of information on these gene-disease links is in the public domain, it’s full of conflicting information, and isn’t curated. Just going through the public literature to try to find the valuable links between genomic abnormality and disease is a daunting task.</p>
<p>“What’s happened historically is kind of a tragedy of the commons,” Scott says. “People put all the variants they study into the public domain, but nobody curates it, cleans it up.” The InVitae team, in doing the curation, has found “enormous errors” that it is weeding out of its central database. The variants in the InVitae database are ones that, Scott says, “accurately predict disease.”</p>
<p>The time is right for such a test, Scott says, because physicians are becoming increasingly interested in not just single-gene or multi-gene diagnostics, but broader genomic tools that can aid in medical diagnosis. Over time, as sequencing gets even cheaper and more scientific links between gene variants and disease are established, InVitae hopes to cast a wider net. In the near future, InVitae hopes to make a single test that scans for all 1,500 known inherited (Mendelian) genetic disorders, and either rules them in or out for an individual patient.</p>
<p>Further in the future—maybe 10 or 20 years, in Scott’s view—newborns will get their full genomes sequenced to look not just for clear inherited disorders, but to delve into predispositions and likelihoods of developing complex diseases that involve multiple genes and environmental factors. Many of these conditions could be spotted early, and managed, long before they start manifesting themselves through mysterious symptoms later in life, Scott says. Disorders like Klinefelter’s syndrome, and hemochromatosis—a common iron-overload condition—can be detected today, but often aren’t, because there’s rarely an obvious reason to look. But InVitae expects that its tests will be able to routinely spot those disorders during its sweeping tests, and those findings could help physicians successfully treat the condition early in life before symptoms cause trouble.</p>
<p>“One of the goals for InVitae is to help manage your genome for life, and do it in a medically oriented way,” Scott says.</p>
<p>Dietrich Stephan, the founder and CEO of SVBio, another aspiring “clinical genomics” entrepreneur, says he’s closely tracking the competition and knows that InVitae has hired a number of experienced people from his previous company, Navigenics. His company is also looking at Mendelian disorders as the first of many genomic diagnostic opportunities.</p>
<p>“I have the highest regard and respect for Randy. I’m looking at it as validating what we’re doing,” Stephan says. “There’s plenty of room in the market for more than one company. Physicians are starved for this.”</p>
<p>The business at InVitae is quite different from Genomic Health, which markets specific diagnostic tests for breast and colon cancer. Those tests must be built on a basis of company-sponsored clinical trials that demonstrate the value of the test for both physicians and payers. By leaning on well-scrubbed, publicly available data from studies of gene variants and rare disorders, InVitae doesn’t need to run lots of expensive clinical trials on its own, Scott says.</p>
<p>The concept for InVitae isn’t actually that new—it was one of the earliest ideas that Scott flirted with back in 2000, in the founding days of Genomic Health. The concept was about what he calls the combination of “Moore’s Law, Metcalfe’s Law, and the law of finite genomes.”</p>
<p>Back then, he saw DNA sequencing tools were on track to get exponentially better, faster and cheaper. The tools would create a flood of DNA data, which isn’t worth much in isolation, but which could be much more valuable when widely shared and compared. The opportunity would someday be within reach, because there are only so many genes and mutations to study that will be really useful for healthcare.</p>
<p>For years, Scott worked on it before concluding that the technology needed to get better. “It was much too early.”</p>
<p>That’s changed now, as instrument makers are racing to develop technology that can sequence entire human genomes for $1,000, in as little as one day. Genomic Health saw the opportunity, invested some in it for a while, but spun it out as the company has other priorities going with specific tests for breast, colon, and prostate cancer.</p>
<p>The market opportunity for something like InVitae could be in the “many billions,” Scott says. Mendelian diseases are one place to start, but even bigger markets could emerge in scouring the genome for cancer. Cambridge, MA-based Foundation Medicine has gotten off to a fast start, and recently attracted an investment from Bill Gates for a genomic test that looks for abnormalities in 200 different cancer-related genes. While Foundation looks for so-called somatic mutations that arise in tumor samples later in life, InVitae envisions looking broadly at the genome for inherited variants that are thought to raise the risk of cancer, Scott says.</p>
<p>How big the various genomic diagnostic markets could be is still anybody’s guess, but Genomic Health alone makes more than $200 million a year, largely off one specific test for breast cancer recurrence. The underlying sequencing technology continues to get faster and cheaper, making it possible for scientists to ask more and more questions that enrich the public databases that InVitae will rely on, and contribute to, as its business grows.</p>
<p>Price, of course, will be a huge factor in determining how widely the tests are adopted, and how well they will be embraced by insurers. InVitae’s service will rise and fall at various points, as technology drives things down, and valuable new features drive things back up, Scott says. Competitors, both publicly declared and stealthy, will also play a role in determining just how high or low the prices will be.</p>
<p>Scott, during a short interview at the JP Morgan Healthcare Conference in San Francisco, seemed to relish all the uncertainty and variables heading his way in the new venture. “We’re really just entering the world, in 2013, where these types of products are coming to market,” he says.</p>
<p>Link: <a title="http://www.xconomy.com/san-francisco/2013/01/18/invitae-led-by-randy-scott-goes-all-in-for-genomic-diagnostics/?single_page=true" href="http://www.xconomy.com/san-francisco/2013/01/18/invitae-led-by-randy-scott-goes-all-in-for-genomic-diagnostics/?single_page=true">http://www.xconomy.com/san-francisco/2013/01/18/invitae-led-by-randy-scott-goes-all-in-for-genomic-diagnostics/?single_page=true</a></p>
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		<title>InVitae: Bringing Metcalfe’s Law to Genomic Medicine &#8212; Bio-IT World, 11/30/12</title>
		<link>http://invitae.com/main/bio-it-article-on-randy-scott/</link>
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		<pubDate>Fri, 07 Dec 2012 22:36:26 +0000</pubDate>
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				<category><![CDATA[News]]></category>

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		<description><![CDATA[Kevin Davies &#124; November 30, 2012 Receiving the 2012 Leadership in Personalized Medicine Award from the Personalized Medicine Coalition (PMC), Randy Scott reflected on his success as the founder and former CEO of Genomic Health, but also looked ahead to new<span class="ellipsis">&#8230;</span><div class="read-more"><a href="http://invitae.com/main/bio-it-article-on-randy-scott/">Read more &#8250;</a></div><!-- end of .read-more -->]]></description>
			<content:encoded><![CDATA[<h2><strong style="font-size: 13px;">Kevin Davies | </strong><strong style="font-size: 13px;">November 30, 2012</strong></h2>
<p><strong style="font-size: 13px;"></strong><span style="font-size: 13px;">Receiving the 2012 Leadership in Personalized Medicine Award from the Personalized Medicine Coalition (PMC), Randy Scott reflected on his success as the founder and former CEO of Genomic Health, but also looked ahead to new opportunities with his latest venture, InVitae Corporation.</span></p>
<p>Scott received the award this week at the 8th annual Personalized Medicine Conference at Harvard Medical School. “Randy has transformed our understanding of how medicine can be practiced by creating one of the most successful personalized medicine companies to date,” stated Brook Byers, a partner with Kleiner Perkins Caufield &amp; Byers and a previous honoree. Past winners of the PMC Award include Janet Woodcock (FDA), Elizabeth Nabel (NIH), Ralph Synderman (Chancellor Emeritus, Duke University), and Leroy Hood (Institute for Systems Biology).</p>
<p>After a successful stint at Incyte, Scott founded Genomic Health in 2000 and led the firm for nine years, overseeing the development of the Oncotype Dx gene expression test for breast cancer. He modestly shared the credit with numerous colleagues. “My contribution was I probably did a good job of hiring a lot of people at Genomic Health who are way smarter than I was,” he said, naming in particular co-founder Joffre Baker, CMO Steven Shak, and CEO Kim Popovits.</p>
<p>As a graduate student in the early 1980s, Scott said he had been excited about biotech but worried he was too late. “All the exciting genes had been cloned! TPA, Factor VIII, human growth hormone, insulin,” he recalled thinking. Today, Scott said, “we’re on the precipice of incredible accelerating change in this field… Everything we’ve experienced to date pales in comparison to what we’re going to experience in the next 5-10 years.”</p>
<p>But he also shed some personal insight into the launch of his latest venture, InVitae Corporation. He said he is “unabashedly excited” about the future of personalized medicine. “Personalized medicine is really when disease happens to you—your friends or your family. Suddenly it’s no longer just an industry we’re working in but something so personal, so intense, and so emotional. We should never forget that.”</p>
<p><strong>The Network Effect</strong></p>
<p>Scott said reading Intel founder Andy Grove’s book Only the Paranoid Survive in the mid-90s, during his tenure at Incyte racing to identify human genes, was highly influential. In the book, Grove discussed the impact of Moore’s Law on the revolution in computing; Scott saw parallels with the biotech industry. “The way we were sequencing DNA [at the time] was so embarrassingly simple,” he said. Just as computing costs were plummeting, Scott reasoned it was inevitable that sequencing costs would also fall.</p>
<p>Perhaps more importantly was the concept of “the network effect.” Just as Metcalfe’s Law—the community value of a network is proportional to the square of the number of its users—drove change in the computing world, so too will it drive the future of biotechnology.</p>
<p>“Having a really cheap genome sequenced is really not very useful. We still see articles in the New York Times, ten years after the genome project, [saying] ‘so what?’ At some level, they’re horribly wrong, and at some level, they’re horribly right. We’ve not yet seen the network effect or the full implication of Moore’s Law.”</p>
<p>Scott said the community is still “1-2 years away from the inflection point” where the cost of sequencing reaches the point that will trigger “massive consumer demand.” The value of genome sequencing will be most strongly felt in the network effect. “How we connect that genomic information across millions and millions of individuals… Somebody can be sitting at a computer, link into the network, and find how a mutation and how it correlates with their patient and a patient somewhere else in the world.”</p>
<p>Scott said he was also a believer in what he called the “Law of Finite Genomes.” The human genome is like a complex finite puzzle with about 150,000 pieces (20,000 genes and 100,000 non-coding RNAs). “All common diseases are really rare diseases,” Scott said, with cancer a prime example. “Medicine goes from an infinite game to a finite game,” he said. By comparing lots of genomic information, we can begin to rule things out.</p>
<p><strong>Patients, Patients, Patients</strong></p>
<p>Scott was inspired to launch Genomic Health when a close friend was diagnosed with colon cancer in 1999. For the first time, Scott was personally struck by the chasm between science/technology and medicine. “We’ve got to bridge the gap—bring the science into clinical practice,” he said.</p>
<p>The focus at Genomic Health, Scott said, was “patients, patients, patients.”</p>
<p>“I’m not sure we had a model other than this maniacal focus on patients that wouldn’t be denied,” he said. If we could really do the science right, the science would sell.” Genomic Health spent an enormous effort on clinical studies.</p>
<p>“Clinical data wins over physicians, and it is physicians that win over the payors,” Scott said. “The onus is on us as an industry to build the value proposition [for payors]… so physicians have to adopt those products. If physicians adopt, they will drive payers to cover.”</p>
<p>Scott left Genomic Health this year to launch InVitae, spurred by the impact of rare genetic diseases affecting members of his family.</p>
<p>In 2000, Scott’s nephew had a daughter with galactosemia. Fortunately, the disorder was diagnosed within 48 hours of birth, and her diet could be changed, otherwise there could have been “a dramatically different outcome.” In 2005, an adopted nephew collapsed on a tennis court and died from hypertrophic cardiomyopathy. Advanced screening could have saved his life, but nobody knew any family history of cardiac disease, he said.</p>
<p>Finally, one of his wife’s relatives had a young son who developed serious seizures at age 2 years. The infant is developmentally impaired and severely autistic. Earlier this year, Scott revealed that exome sequencing of the child and his parents revealed a single de novo point mutation as the putative cause of the disorder. This is unlikely to provide any tangible medical benefit, but “it gives a clue into potential causes of these disorders,” he said.</p>
<p><strong>Ridiculous Goal</strong></p>
<p>Scott said his goal in launching InVitae was to bring the power of genetics into the real world of clinical practice. “We have a ridiculous goal,” he said. “We want to aggregate all of the world’s genetic tests into a single assay—for less than the cost of a single assay today!”</p>
<p>In other words, InVitae plans to collapse all Mendelian inherited traits into a single assay that can be performed “reproducibly, at high quality and at reasonable cost for the medical system. So instead of going into these diagnostic odysseys… every parent thinking about conceiving a child can know exactly what their carrier status is and what disease risks lie in their family.”</p>
<p>The initial assay will essentially be an elaborate gene panel, but Scott’s plan is eventually that this will lead into whole-genome sequencing (WGS). Scott believes that “within 10-20 years, everyone in any developed health care system will be able to be provided with a low-cost [WGS] analysis at birth&#8230; We’ll be talking about managing your genome over the course of your lifetime.”</p>
<p>As for the question of how to deal with the plethora of data, “that’s Metcalfe’s Law, the network effect,” said Scott. “Much of the data won’t be of value to the patient or physician ordering the test. But collectively, they will be massively valuable to the research community.”</p>
<p>We’re big fans of “Free the Data!” said Scott. The universe of clinical genetic data “won’t be a database held by one company or one academic institution, but you’ll see a massive movement over the course of the next decade to make data broadly available within the research community.” This will create a huge disruption in medicine, Scott predicted, a shift from phenotypically driven medicine to more of a genotype foundation as sequencing costs fall and the network builds.</p>
<p>“Everything will drive off the genotype and it will move very fast,” he said. “This is a given. To me, this is the investment thesis. This will be the place to be, the chance to help people suffering from rare diseases. At the end of the day, every disease is rare.”</p>
<p>InVitae is building a strong management team. The company recently merged with Locus Development, a start-up co-founded by Sean George and Michele Cargill, founding scientists at Navigenics. Steve Lincoln and Jill Hagenkord, both formerly with Complete Genomics, also joined the cause this year, as did Reece Hart, former manager of research computing and informatics at Genentech.</p>
<p>Link: <a href="http://www.bio-itworld.com/2012/11/30/randy-scott-bringing-metcalfe-law-genomic-medicine.html">http://www.bio-itworld.com/2012/11/30/randy-scott-bringing-metcalfe-law-genomic-medicine.html</a></p>
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		<title>Joining Forces with Locus Development</title>
		<link>http://invitae.com/main/joining-forces-with-locus-development/</link>
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		<pubDate>Wed, 08 Aug 2012 21:00:00 +0000</pubDate>
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				<category><![CDATA[News]]></category>

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		<description><![CDATA[Genomic Health Announces Second Quarter 2012 Financial Results and Business Progress - Product Revenue Increased 13% Compared with Prior Year - - Delivered Net Income of $1.8 Million - - Began Offering Oncotype DX® Colon Cancer Test for Stage III<span class="ellipsis">&#8230;</span><div class="read-more"><a href="http://invitae.com/main/joining-forces-with-locus-development/">Read more &#8250;</a></div><!-- end of .read-more -->]]></description>
			<content:encoded><![CDATA[<h2 id="wsh_printBar">Genomic Health Announces Second Quarter 2012 Financial Results and Business Progress</h2>
<p>- Product Revenue Increased 13% Compared with Prior Year -<br />
- Delivered Net Income of $1.8 Million -<br />
- Began Offering Oncotype DX® Colon Cancer Test for Stage III Patients -<br />
<span style="color: #000000;"><strong>- Combined InVitae with Locus Development to Create Independent Genetics Company -</strong></span><br />
- Conference Call Today at 4:30 p.m. ET -</p>
<p>REDWOOD CITY, Calif., Aug. 8, 2012 /PRNewswire/ &#8211; Genomic Health, Inc. (Nasdaq: GHDX) today reported financial results and business progress for the quarter ended June 30, 2012.</p>
<div>
<p>EXCERPT FROM PRESS RELEASE REGARDING INVITAE ONLY:</p>
<p><strong>Update on InVitae:</strong></p>
<p>&#8220;As the InVitae business strategy has evolved, we recognized an increasing distinction from our core business in cancer and, at the same time, identified meaningful synergies with Locus Development, a privately held company we have been investors in since 2011. We have concluded that the best path forward is to support the combination of the two entities as a separate independent company under the leadership of Randy Scott,&#8221; said Kim Popovits.  &#8220;In becoming Chairman of the Board and CEO of the combined entity to be called InVitae, we fully support Randy&#8217;s decision to step down from our Board of Directors as he turns his full attention toward building a world class company to advance the use of genetics in the clinical setting, and believe this is the ideal way for Genomic Health to optimize our investment in genetics.&#8221;</p>
<p>Genomic Health has committed to make an additional investment of up to $5 million in the combined entity&#8217;s current Series C financing round, resulting in an ownership position of less than 20 percent, with a right to increase its ownership in a future round of financing.</p>
<div>For entire press release, see:</div>
<div><a href="http://investor.genomichealth.com/releasedetail.cfm?releaseid=699340">http://investor.genomichealth.com/releasedetail.cfm?releaseid=699340</a></div>
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		<title>Company Formation</title>
		<link>http://invitae.com/main/company-formation/</link>
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		<pubDate>Mon, 06 Feb 2012 22:00:18 +0000</pubDate>
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		<description><![CDATA[Genomic Health Announces Formation of New Genetics Subsidiary New Venture to Focus on Integrating Clinically Relevant Genetic Information from the Human Genome into Routine Medical Practice Randy Scott to Lead Subsidiary, Kim Popovits to Assume Role of Chairman of Genomic<span class="ellipsis">&#8230;</span><div class="read-more"><a href="http://invitae.com/main/company-formation/">Read more &#8250;</a></div><!-- end of .read-more -->]]></description>
			<content:encoded><![CDATA[<h2 id="wsh_printBar">Genomic Health Announces Formation of New Genetics Subsidiary</h2>
<h5>New Venture to Focus on Integrating Clinically Relevant Genetic Information from the Human Genome into Routine Medical Practice</h5>
<h5>Randy Scott to Lead Subsidiary, Kim Popovits to Assume Role of Chairman of Genomic Health, Julian Baker Named Lead Independent Director of Genomic Health</h5>
<p>REDWOOD CITY, Calif., Feb. 6, 2012 /PRNewswire/ &#8211; Genomic Health, Inc. (Nasdaq: GHDX) today announced plans to establish a wholly owned subsidiary with the goal of improving the quality of diagnosis, communication and support for millions of patients and their families faced with common and rare genetic conditions.   The subsidiary is expected to be established by March 1, 2012 and provide its first commercial service in 2013.  The new venture will be led by Randy Scott, who in his role as Executive Chairman for the past three years has focused on commercial applications of next generation sequencing.</p>
<div>
<p>The new subsidiary will focus on accelerating the integration of the human genome into medical practice with an emphasis on bioinformatics and clinical utility.  Dr. Scott will be CEO of the new subsidiary and remain a Genomic Health Board member and Kim Popovits, President and Chief Executive Officer, will assume the additional role of Chairman of the Board effective March 1, 2012.  In a related action, Julian Baker has been named as Lead Independent Director.</p>
<p>&#8220;As the cost of DNA sequencing continues to drop, new medical applications with the potential to impact millions of people are rapidly emerging,&#8221; said Randy Scott, Executive Chairman of Genomic Health.   &#8220;We are at a unique turning point in medicine and believe the investment we have made over the past several years in the development of a robust next generation sequencing platform and the capabilities we have established in building a successful cancer genomic business make this the ideal time to expand into both common and rare genetic conditions and expect this new start-up to be a significant long-term contributor to the company&#8217;s growth.&#8221;</p>
<p>Read more at:</p>
<p><a href="http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=646452">http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=646452</a></p>
<p>&nbsp;</p>
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