Archive for the ‘Personalized Medicine’ Category

ROCKVILLE, MD--(Marketwire -03/07/12)- MarketResearch.com has announced the addition of the new report "World Market for Personalized Medicine Diagnostics (Biomarkers, Pharmacodiagnostics, Tumor Assays, Cardiac Risk and Other Testing)," to their collection of Biotechnology market reports. For more information, visit http://www.marketresearch.com/Kalorama-Information-v767/Personalized-Medicine-Diagnostics-Biomarkers-Pharmacodiagnostics-6837679/

A new report available on the world's largest online distributor of market research says that 'personalized medicine' may resemble medicine's version of the dot com craze of the 90s, but there are real revenues being made and real potential for earnings. The report, Personalized Medicine Diagnostics, says the market will reach $37,480 million in 2016 worldwide.

"Personalized medicine is becoming the place to be in clinical diagnostics, manufacturers extol the "personalized" nature of their tests and services even though this may be a bit of a stretch even when using the most liberal definition of personalized. It is reminiscent of the dot-com craze of the 1990s," according to Shara Rosen, author of the report.

Yet the truth is, there is and has been a lot of individualized therapy in recent decades including infectious disease tests, blood banking tests and transplant qualification tests. The phenomenon of test personalization comes under many guises -- pharmacogenomic, pharmacogenetic, companion tests, and represents one of the fastest growing segments of the diagnostics market. It has emerged fully from research into clinical practice. Instrumentation now automates many of the sample preparation and assay steps that were formerly labor intensive. New tests are being launched all the time. Some personalized medicine (PMx) tests are CE Marked and FDA-cleared and many more are in development. The result is that PMx testing is indicated in many areas of health care including: cardiology, oncology, infectious diseases, inherited diseases and disorders. PMx tests have made rapid and timely information about infectious diseases and bacterial infections a reality.

For more information, visit http://www.marketresearch.com/Kalorama-Information-v767/Personalized-Medicine-Diagnostics-Biomarkers-Pharmacodiagnostics-6837679/

About MarketResearch.com

MarketResearch.com is the leading provider of global market intelligence products and services. With research reports from more than 700 top consulting and advisory firms, MarketResearch.com offers instant online access to the world's most extensive database of expert insights on global industries, companies, products, and trends. Moreover, MarketResearch.com's Research Specialists have in-depth knowledge of the publishers and the various types of reports in their respective industries and are ready to provide research assistance. For more information, call Veronica Franco at 240-747-3016 or visit MarketResearch.com.

See the article here:
Personalized Medicine: New Dot Com Craze?

CAMBRIDGE, UK--(BUSINESS WIRE)--

Lab21 Limited, the global specialist in personalized medicine and clinical diagnostics, today announces the launch of a new Clinical Genomics Center located within the Greenville Hospital System (GHS) Memorial Medical Campus in Greenville, South Carolina.

The center will be physically located within the GHS Institute for Translational Oncology Research (ITOR) as part of an on-going collaboration to facilitate the introduction of complex biomarker analysis into routine cancer patient management. This represents a long-standing commitment from the local oncology community and Lab21 to introduce state-of-the-art next-generation sequencing (NGS) technology as part of its growing translational medicine clinical services portfolio in the US.

Bringing this leading-edge technology to the cancer clinic represents a significant breakthrough and the culmination of a seven-year journey, said Dr. Joe Stephenson, medical director for ITOR. This genomics center is another major step towards fulfilling our vision to provide personalized cancer care better enabling us to offer the right drug, at the right time, to the right patient.

The establishment of this center was facilitated through a strategic relationship with Life Technologies who are providing their new Ion Torrent Personal Genome Machine as the key launch platform technology. Michael Bolick, President of Lab21 Inc., explained we conducted extensive due diligence on the underpinning technology for the center and are confident that our engagement with Life Technologies will enable us to offer a comprehensive and cost-effective NGS service to the oncology community.

Lab21s CEO, Graham Mullis, said: This is a major step forward for Lab21 in North America and we are delighted to be working with Dr. Joe Stephenson and the team at ITOR in this fast changing market of personalized medicine. The establishment of this center underlines our commitment to our personalized medicine strategy and to introduce state-of-the-art molecular services and products into North America. It also reinforces our relationship with ITOR and the potential to use this technology for clinical trial applications with a view to identifying new biomarkers which can subsequently build our proprietary companion diagnostic portfolio. Importantly, it marks our intention to utilize this NGS technology in other therapeutic areas in addition to oncology. Lab21 is a company with an established business in infectious diseases, particularly virology, and we are already negotiating new contracts to exploit this expertise using NGS technology.

END

About Lab21

Lab21 is a global leader in personalized healthcare. It provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. Lab21 customers include international healthcare providers, pharmaceutical and diagnostic companies. The Products division of Lab21 manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. Our clinical services operations have a growing test portfolio providing companion diagnostics and high technology molecular assays. Lab21's corporate offices are based in Cambridge, UK and Greenville, South Carolina, with a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley, Manchester and Bridport. Website: http://www.lab21.com

About GHS

See more here:
Lab21 and ITOR launch Clinical Genomics Center in USA

PETERBOROUGH, NH--(Marketwire -03/05/12)- G2 Intelligence announced today that Stafford O'Kelly, President of Abbott Molecular and Chair of the Personalized Medicine Coalition, will deliver the opening keynote address, "Putting Molecular Diagnostics to Work: What's Now and What's Next," at MDx NEXT, G2 Intelligence's seventh annual molecular diagnostics conference.

"With his depth and breadth of experience in this rapidly growing area of testing, Stafford O'Kelly is an exciting addition to our agenda," said Stephanie Murg, Managing Director of G2 Intelligence and MDx NEXT Program Chair. "Labs who want to add molecular diagnostics or optimize their current offerings will benefit enormously from Mr. O'Kelly's insights."

Mr. O'Kelly joins fellow keynote speakers Lone Frank, Ph.D., and Kenneth H. Buetow, Ph.D., who will speak on:

With a continued focus on the vibrant exchange of ideas and best practices that characterize all G2 conferences, this year's event also features a stronger emphasis on molecular diagnostic testing as a vital engine of growth for clinical laboratories of all types and sizes.

With this in mind, the new agenda showcases an exploration of key insights and opportunities around such topics as:

Distinguished faculty in attendance to include:

To find out more, or to register for MDx NEXT, go to http://www.MDxConference.com or call 1.800.401.5937. Group discounts are available for three or more people from the same organization. For group registrations, please call Jeff Watkins at 973.718.4709 to facilitate your registration, or email jwatkins@G2Intelligence.com.

Sponsors of this year's event include McKesson, Cleveland Clinic, XIFIN, Kellison & Company, and Quadax. Additional exhibitors at MDx NEXT will include Bioview, hc1.com, Streck, NeoGenomics, and Halfpenny Technologies. For information on sponsorship/exhibitor opportunities, please contact Patrice Hampson at 603-371-2126 or via email at phampson@G2Intelligence.com.

About G2 Intelligence

Advancing the Business of Diagnostic Medicine

Follow this link:
Abbott Molecular President Stafford O'Kelly to Deliver Opening Keynote at MDx NEXT in Boston

29-02-2012 10:12 In this episode of The JFK Download, David Avitabile, President, JFK Communications, explains the importance of diagnostics and personalized medicine in the pharmaceutical and life sciences industries. JFK Communications is proud to sponsor BioNJ's Innovation Summit taking place March 14 at Princeton University. If you're involved in personalized medicine and diagnostics, don't miss out on a great opportunity to hear from industry leaders on this topic. For more information and to register: http://www.bionj.org

More here:
JFK Download Dave Avitabile - The Importance of Diagnostics and Personalized Medicine 2.m4v - Video

By Turna Ray

After the Patient-Centered Outcomes Research Institute held a meeting this week to gather public input on its comparative effectiveness research priorities, personalized medicine stakeholders are still uncertain to what degree the institute will fund studies that aim to define how well drugs work in molecularly distinct patient groups or if it will mostly fund research to gauge how interventions work in the general population.

Another unknown as PCORI further defines its CER framework is whether "patient-centered research" a term the institute has been working to define with public input will explicitly mention personalized medicine principles. Whether it does or not could signal whether comparisons of genomic medicine to the standard of care will be a major focus of PCORI's CER efforts.

PCORI, a non-profit organization formed by the 2010 Patient Protection and Affordable Care Act, has issued a draft document outlining the research areas in which it wants to conduct studies comparing the safety and efficacy of medical interventions, healthcare delivery models, and infrastructure. The findings from such CER, PCORI hopes, will help drive informed healthcare decision making, improve patient outcomes, and reduce unnecessary spending in healthcare.

The public was invited to discuss the preliminary research agenda with PCORI and key stakeholders at a meeting this week. PCORI is also accepting written comments on its draft research agenda until March 15.

PCORI is planning to spend $122 million for research activities in 2012, and it's possible that some of this money may go toward funding CER on molecularly targeted personalized medicine products. According to PCORIs statutory purpose, the research the institute supports must consider how disease can be prevented, diagnosed, and treated in patient subpopulations, which could include groups defined by molecular subtypes.

Regardless, some believe that the focus areas outlined in PCORI's draft research agenda are too broad, and personalized medicine principles, which are still new and evolving, can very easily get lost in the mix.

"PCORI was designed to address specific, practical questions of national importance," Amy Miller, vice president of public policy for the advocacy organization Personalized Medicine Coalition, said at the meeting according to prepared comments provided to PGx Reporter. "However, the broad and vague drafting of the research priorities is more appropriate for traditional, investigator-driven research, which may or may not address the types of questions PCORI must answer."

In addition, "since broad drafting does not allow for an examination of individual research proposals, topics, or research questions, it is not possible to say whether PCORIs work will support personalized medicine or not," Miller said.

Since PCORI was formed, the PMC has been trying to remind the institute's leaders that their charge isn't just to look at whether most people respond better to one drug over another, but to investigate how and why treatments work best in some people with a unique set of characteristics. "It is not enough, in the PMCs opinion, to say that one therapy works for most people in the aggregate," Miller said. "To enable personalized medicine, research must explain why a therapy works and for what types of patients."

Read this article:
Will PCORI's Patient-Centered Comparative Effectiveness Research Track with Personalized Rx?

24-02-2012 18:53 In February 2012, the FDA published 3 Guidance documents for biosimilars. Under the Biologics Price Competition and Innovation Act (BPCI Act), a biological product may be demonstrated to be "biosimilar" if data show that, among other things, the product is "highly similar" to an already-approved biological product. George Dranitsaris discusses the market and challenges of biosimilars.

Read the rest here:
Biosimilars and the FDA Guidance Documents - a discussion at Personalized Medicine TV - Video

21-02-2012 06:08 The guest of is episode of http://www.PersonalizedMedicineTV.com is Andrew Schorr, the author of the book "The Web-savvy Patient". Andrew Schorr is a pioneer in Internet health and medical programs who became a patient himself, participating in a clinical trial and surviving leukemia. This followed 25 years as a reporter, producer and national reality television programmer. Andrew shares his views and advise on the relationship between patient and doctor and on personalized medicine. Please watch the episode and post your comments and questions.

See original here:
"The Web-savvy Patient" book author Andrew Schorr on Personalized Medicine - Video

By Matt Jones

NEW YORK (GenomeWeb News) – The Penn State Milton S. Hershey Medical Center and the Penn State College of Medicine have launched a new institute that will focus on personalized medicine and engage in interdisciplinary research with other institutes at the campus.

The Penn State Hershey Institute for Personalized Medicine will connect faculty, resources, and programs currently at the school to advance research areas that could translate into clinical applications, Penn State Hershey said late last week.

The institute will collaborate with departments and institutes around the Penn State Hershey campus, including the Penn State Clinical and Translational Science Institute, to translate research findings into clinical applications.

The institute, which will move into its permanent lab space in the College of Medicine in June, will obtain blood and other biosamples from consenting patients at the Medical Center which will then be stored in a biorepository, also housed on campus.

Along with the samples, information about the patients' treatments and outcomes stored on electronic medical records will be deposited in a database for use in correlation studies, James Broach, who chairs the department of biochemistry and molecular biology at Penn State College of Medicine and who will be the inaugural director of the institute, told GenomeWeb Daily News on Monday.

"This has the potential to expand to the nearly a million people who come through the hospital and the associated clinics under the umbrella of the Hershey Medical Center," he said.

Depending on the disease interest, the samples can be pulled from the repository and analyzed in any number of ways, including conducting SNP analyses using Illumina's SNP arrays, and in-house deep sequencing studies with the Illumina HiSeq and other next-generation sequencing platforms, Broach said.

The large volumes of data the institute expects to generate will be analyzed by researchers at Penn State's University Park campus using the Galaxy software package to identify relevant SNPs for each individual patient. Developed by Penn State and Emory University, Galaxy is an open source system for data integration and analysis that was developed for genomics research and now is used as a general bioinformatics workflow management system.

The institute will then seek to compare the genomic information with the outcome and treatment data found in the EMRs.

Establishing correlations between genotype and outcomes is the hard part, Broach explained, because of the large number of patients that are required to identify parts of the genome that are correlated to diseases with any statistical significance.

"Our approach will be much in the way that people are beginning to think about doing clinical trials with limited a number of patients – where you keep redirecting the cohort as the information comes in," Broach said.

The early phases of research will focus on this type of study, with the longer aim of generating knowledge linking genes and variants with outcomes in ways that could be used in treatment.

"Ultimately, the goal will be that when the patient comes in, we take their blood samples, we do the sequence, we get the SNPs, and on the basis of our previous correlations, you can make the prediction that this person would respond to one treatment versus another treatment," he said.

View original post here:
Penn State Launches Personalized Medicine Institute

NEW YORK, NY--(Marketwire -02/27/12)- Personalized medicine, or matching an individual patient to an individual treatment, has long been part of diagnostic testing, according to healthcare market research publisher Kalorama Information. But Kalorama estimates that new proven biomarkers, and a desire to better target cancer therapy, have grown personalized medicine testing to a $28 billion market in 2011. This finding was made in Kalorama's latest report: World Market for Personalized Medicine Diagnostics.

"The excitement over personalized medicine is reminiscent of the dot-com era, but the concept is not completely new," says Kalorama's lead diagnostic analyst Shara Rosen. She notes in the report that matching a drug's effectiveness with a patient's genetics has been considered since the 1950s. Blood testing, transplant tissue testing, microbial identification and AST susceptibility are examples of individualized testing that Rosen notes have been part of medicine for decades and these are considered in the report's analysis.

However, the study acknowledges that the current excitement in IVD, and a share of the growth in this market, is coming from new molecular tests and the profiling of solid cancer tumors, which the report says are creating an entirely new paradigm for diagnosing and choosing treatment options. These new tests are driving the market to better-than-average growth rates compared to other segments of the IVD market. Kalorama sees the primary growth drivers in the market are the discovery of biomarkers with clinical utility and better reimbursement for testing. But as the author of the report notes, the missing piece that is making the concept a reality is recent technology improvements.

"Cost-effective multiplex platforms, high powered software, assays using saliva, urine, and blood instead of biopsied tissue, these are the technological tools that make more sensitive and specific tests possible," says Rosen.

Kalorama also notes in the report that healthcare delivery trends and novel therapeutics help refocus the role of laboratory medicine in disease management to the patient by helping individualize diagnoses and treatments. Decentralization and wider availability of PMx (personalized medicine) tests can only happen with the conversion of lab-developed tests (LDTs) to CE Marked and FDA-cleared molecular testing methods. Advances in cancer therapies and the allure of personalized medicine provide another compelling argument for growth in the routine use of these tests.

In the full study, World Market for Personalized Medicine Diagnostics, Kalorama Information defines the current opportunity and realistic future potential of personalized medicine in clinical testing. In addition to analysis of tests currently on the market and in development, the report profiles key competitors and discusses trends that are important for understanding this much-discussed growth area of the diagnostic industry. It also profiles scores of companies that are involved in making tests for this market.

About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog.

Read the original:
Kalorama: "Personalized Medicine" May Not Be New, but It Is Growing

TRENTON, N.J.--(BUSINESS WIRE)--

BioNJ, the trade association for New Jersey’s biotechnology industry, will host its biggest and most interactive event to date for companies involved in diagnostics and personalized medicine on March 14, 2012 at Princeton University. The BioNJ Diagnostics & Personalized Medicine Innovation Summit and Funding Roundtable, part of BioNJ’s ongoing Diagnostics & Personalized Medicine Initiative, will bring together leaders from major global biotechnology and pharmaceutical companies, diagnostics companies and emerging “innovator” companies for a half-day, interactive summit meeting.

The focus of this half-day summit is to help participants identify opportunities for partnership, funding and growth while updating them on the latest trends, developments and challenges in the evolution and adoption of personalized medicine. All companies and individuals with an interest in diagnostics and personalized medicine are welcome to attend this event. The Summit will include company presentations and opportunities for one-on-one communication and interaction between leading global pharmaceutical companies, emerging diagnostics companies, funding organizations and life sciences company business development professionals.

“This event promises to be truly unique for those who attend,” said Debbie Hart, President of BioNJ. “Not only have we confirmed first-class speakers from all key constituencies involved with diagnostics and personalized medicine, we will also create opportunities for global life science leaders, smaller innovators and members of the investment community to network and establish partnerships that will advance the development and utilization of personalized medicine worldwide.”

Speaking at the Summit will be leaders from the global investment community, global life sciences companies and academia:

G. Steven Burrill
Chief Executive Officer, Burrill & Company

Joseph P. Hammang, Ph.D.
Senior Director, Worldwide Science Policy, Pfizer Inc.

Paul Kildal-Brandt
Global Alliance Leader, Janssen Diagnostics

Aydogan Ozcan, Ph.D.
The Scientist's Top Innovation Award Winner of 2011
Associate Professor, UCLA
Electrical Engineering & Bioengineering Department

The BioNJ Diagnostics and Personalized Medicine Committee, which created the BioNJ Diagnostics & Personalized Medicine Innovation Summit and Funding Roundtable, is also planning additional events focusing on diagnostics and personalized medicine, and will be announcing details for future events on its website.

“The increasing interest in diagnostics and personalized medicine, and its potential to transform medicine, is clear from the participation in the events that the BioNJ Diagnostics and Personalized Medicine Committee has offered so far,” said Steve Carchedi, Committee Co-Chair, Chief Marketing Officer, Medical Diagnostics, GE Healthcare. “The BioNJ Diagnostics & Personalized Medicine Innovation Summit and Funding Roundtable will be our biggest event ever, and I encourage anyone with an interest in diagnostics and personalized medicine to join us on March 14th at Princeton University,” he added.

About the BioNJ Diagnostics Committee

The BioNJ Diagnostics and Personalized Medicine Committee was created to advance personalized medicine through diagnostics by identifying and supporting partnerships with industry, academic, government and investors in the State of New Jersey.

The goal of the committee is to define and accelerate new areas of diagnostics, such as in vivo and in vitro tests, biomarkers, imaging, information systems and other innovative technologies.

About BioNJ

With more than 300 member companies, BioNJ is singularly focused on the growth and prosperity of New Jersey’s biotechnology cluster. Founded in 1994 by New Jersey industry CEOs, BioNJ serves as the voice of biotechnology companies located in New Jersey, seeks to advance their economic growth and development and works to encourage new and established companies from around the world to locate to New Jersey. BioNJ represents companies engaged in biopharmaceutical, biomedical, bioagricultural and bioremedial endeavors.

Link:
BioNJ Diagnostics & Personalized Medicine Innovation Summit and Funding Roundtable Taking Place at Princeton University

20-02-2012 18:40 This episode of http://www.PersonalizedMedicineTV.com covers discussion of personalized medicine vs. genomic medicine and terminology related to this topic. Ralph Snyderman, MD, who is with the Center for Research on Prospective healthcare, Department of Medicine, Duke University delves on the terminology related to personalized Healthcare.

Read the rest here:
Personalized Medicine is more than Genomic Medicine - Video

12-01-2012 09:46 Expert panel #4: Personalized Medicine, Connected Health: The Accelerating Convergence of Genomics, Information Technology and Healthcare (Imperial) Moderator: Scott Lundstrom, Group Vice President, IDC Health Insights - Toby Bloom, PhD, Director of Informatics, Genome Sequencing Platform, The Broad Institute - George Church, PhD, Director, Center for Computational Genetics, Harvard Medical School; winner, 2011 Bower Award and Prize for Achievement in Science - Rodrigo Martinez, Life Sciences Chief Strategist, IDEO

More here:
2011 Connected Health Symposium: Expert Panel: Personalized Medicine - Video

18-11-2011 13:50

Go here to read the rest:
GPEC: What is personalized medicine? - Video

16-02-2012 15:07 Watch video of Dr. Dan Roden speaking about personalized medicine. Roden spoke Jan. 25 as part of the Osher Lifelong Learning class, "Medical Advances." The course is presented by faculty of the Vanderbilt University Medical Center and focuses on what the future of medicine holds. Physicians are now able to use a patient's DNA to select the right drug for treatment. Oncologists can 'read' the DNA of a patient's tumor and tailor treatment for their particular version of cancer. New medical devices have provided new heart valves, 'pace-makers' for the brain, and the tools needed to rebuild a spine. This series of lectures introduces medical and surgical treatments that are changing lives today and a preview of the discoveries that are still "works in progress" at Vanderbilt. The class is part of the Osher Lifelong Learning Institute at Vanderbilt. The non-credit classes are intended for older adults who want to pursue lifelong learning with the stimulus of lectures and discussions in an informal and relaxed environment.

See the article here:
Dr. Dan Roden: "Personalized Medicine: Your genome and the future of medicine" - Video

ROCKVILLE, MD--(Marketwire -02/16/12)- MarketResearch.com has announced the addition of the new report "Personalized Medicine Market Analysis," to their collection of Biotechnology market reports. For more information, visit http://www.marketresearch.com/RNCOS-v3175/Personalized-Medicine-6746156/

With the increasing knowledge of human DNA, a new segment called personalized medicines has emerged in the healthcare industry, which includes therapeutics, diagnostics, and theranostics tailored towards the treatment or prevention of disease. Even though personalized medicines are in their nascent stages, it is expected to transform the biopharmaceutical and molecular diagnostics markets in the coming years.

According to "Personalized Medicine Market Analysis," the US market for personalized medicine is anticipated to grow at a CAGR of around 9.5% during 2009-2015. The growth will be driven by factors, such as treatment cost savings, early detection of diseases, patient compliance, drug safety, and optimization of therapies.

The US has the major share in the global personalized medicine market. But with the advancements, countries like the UK, France, Germany, India, China, and Japan have also been trying to establish themselves in the market. In order to promote the development of personalized medicines, huge money is being invested. For instance, US$780 Million have been invested in the UK to establish an institute for aiding the development of clinical applications to fight cancer, heart diseases, and neurodegenerative disorders.

Strategic alliances, like the Abbott Laboratories with Pfizer are also being formed. Academic and private research institutions as well as small biotech and major pharmaceutical companies are increasingly looking for alternative ways to strengthen their pipelines.

The research reveals that personalized medicines for cancer are dominating the market, accounting for more than half of the total personalized medicines which are commercially available. The therapeutic applications of personalized medicines have been extending to new areas, like HIV, cardiovascular disorders, neurological disorders, etc. It is expected that these applications will grab a bigger piece of the pie in the coming years.

Providing an extensive information and rational analysis of the global personalized medicine market, the research report thoroughly examines current market trends and industrial developments to enable clients with a proper understanding of the market structure and its future progress. The study also provides an insight into the segment-wise competitive landscape, which includes the profiles of Pharmaceutical/Biotech, Diagnostic, IT/Informatics, and Research Tool companies across the globe.

For more information, visit http://www.marketresearch.com/RNCOS-v3175/Personalized-Medicine-6746156/

About MarketResearch.com

MarketResearch.com is the leading provider of global market intelligence products and services. With over 300,000 research reports from more than 700 top consulting and advisory firms, MarketResearch.com offers instant online access to the world's most extensive database of expert insights on global industries, companies, products, and trends. For more information, call Veronica Franco at 240-747-3016 or visit http://www.MarketResearch.com.

Here is the original post:
Market Research Projects US Personalized Medicine Market Growth at 9.5% CAGR Through 2015

SANTA CLARA, Calif.--(BUSINESS WIRE)--

Affymetrix, Inc. (NASDAQ:AFFX - News) today announced that its GeneChip® System 3000Dx v.2 (GCS 3000Dx v.2) has been approved by China's State Food and Drug Administration (SFDA) for in vitro diagnostic use. The GCS 3000Dx v.2 is the first microarray instrument system to be granted SFDA registration for array-based diagnostics for enabling personalized medicine. China has more than 2,000 clinical centers that will now have access to the only SFDA-cleared microarray platform for clinical testing.

The molecular diagnostic market in China is the fastest growing in the world and represents a significant growth opportunity for Affymetrix in Asia. “We are delighted to be the first SFDA-cleared microarray platform, as this will enable us to expand into the clinical diagnostics applications,” says Chris Barbazette, Vice President, Commercial Operations International Markets at Affymetrix.

The GCS 3000Dx v.2 microarray platform has a proven record of successful development and commercialization through partnership via the Powered by Affymetrix™ (PbA) program. A number of companies are developing molecular diagnostic tests in cancer, cardiovascular diseases, and inherited disorders based on the Affymetrix GeneChip platform. More than ten tests are in the pipeline for regulatory clearance. Two FDA-cleared tests (Roche AmpliChip® CYP450 Test and Pathwork® Diagnostics' Tissue of Origin Test) and three CE-IVD marked tests, including Skyline Diagnostic’s AML test, are currently on the market. These tests and Affymetrix’ own solutions for cytogenetics, cancer, and pharmacogenomics are part of an increasing menu of clinical applications that can be run on the SFDA-cleared GeneChip System.

“Having an SFDA-cleared system and a wide-range of clinical tests will enable physicians in China to bring personalized medicine to their patients faster,” says Dr. Ming Zhang at Hangzhou Bio-San Biochemical Technologies Company.

“This registration clearance is a significant accomplishment for Affymetrix and supports our global clinical strategy. It connects us more closely to physicians in China wanting to utilize clinically relevant genomic biomarkers that improve their patients’ health and wellness,” said Andy Last, Executive Vice President of Genetic Analysis and Clinical Applications Business Unit at Affymetrix.

The GCS 3000Dx v.2 microarray System is cleared for in vitro diagnostic use in the United States, Japan, CE-IVD marked in Europe, and is also available in Canada, Singapore, Australia, India, and Saudi Arabia.

In addition to the GCS 3000Dx v.2, Affymetrix also offers a Clinical Toolkit, which contains the US FDA-cleared and CE-IVD marked Gene Profiling Reagents and the Gene Profiling Array cGMP U133 P2, the cGMP-manufactured version of the widely cited GeneChip® Human Genome U133 Plus 2.0 Array. The Affymetrix® Clinical Toolkit provides a proven path to market, enabling test developers to save time and money while reducing regulatory risks.

About Affymetrix

Affymetrix technology is used by the world's top pharmaceutical, diagnostic, and biotechnology companies as well as leading academic, government, and nonprofit research institutes. About 2,200 systems have been shipped around the world, and more than 25,000 peer-reviewed papers have been published using the technology. Affymetrix is headquartered in Santa Clara, CA, and has manufacturing facilities in Cleveland, Ohio, and Singapore. The company has about 900 employees worldwide and maintains sales and distribution operations across Europe, Asia, and Latin America. For more information about Affymetrix, please visit http://www.affymetrix.com.

Forward-looking statements

All statements in this press release that are not historical are "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix' "expectations," "beliefs," "hopes," "intentions," "strategies" or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to: risk relating to the Company’s ability to successfully commercialize new products, risk relating to past and future acquisitions, including the ability of the Company to successfully integrate such acquisitions into its existing business; risks of the Company's ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses; uncertainties relating to technological approaches, risks associated with manufacturing and product development; personnel retention; uncertainties relating to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties relating to sole-source suppliers; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix' Annual Report on Form 10-K for the year ended December 31, 2010, and other SEC reports. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Affymetrix' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

PLEASE NOTE: Affymetrix, the Affymetrix logo, GeneChip, and all other trademarks are the property of Affymetrix, Inc.

See the article here:
China Clears Its First Microarray Platform for in Vitro Diagnostics to Accelerate Personalized Medicine

Public release date: 14-Feb-2012
[ | E-mail | Share ]

Contact: Annie Hayashi
hayashi@ors.org
847-430-5025
Orthopaedic Research Society (ORS)

Imagine a smart sensor customized to provide vital, real-time information about a patient's recent orthopaedic surgery. Instead of relying on X-rays or invasive procedures, surgeons will be able to collect diagnostic data from an implantable sensor. A study presented at the Orthopaedic Research Society 2012 Annual Meeting in San Francisco outlined this remarkable technology that promises to make post-surgical diagnosis and follow up more precise, efficient, and cost-effective.

"The sensor provides opportunities to make specific and detailed diagnostics for a particular patient and to tailor care based on very objective and quantitative measures," said Eric H. Ledet, PhD, Assistant Professor, Rensselaer Polytechnic Institute.

"This highly unique sensor is very small (4 mm diameter and 500 microns thick), is wireless, batteryless, and requires no telemetry within the body. Its simplicity makes it less prone to failure and very inexpensive to produce," Dr. Ledet explained.

The orthopaedic implant acts as a carrier for the sensor. The wireless sensor can monitor load, strain, motion, temperature, and pressure in the challenging in vivo environment. It can be placed into a spinal or fracture fixation implant, for example, to determine the patient's progress.

"For the patient that is progressing well, the information from the sensor enables the physician to determine that the patient can return to work without risk of injury," said Dr. Ledet. "The number of lost days at work is reduced."

It can also alert the physician to potential problems, indicating that additional interventions may be needed. "By maintaining a simple platform, we're able to customize the sensor and make it very, very small so it can be incorporated into a lot of different implants," said Rebecca A. Wachs, MS, Rensselaer Polytechnic Institute. "By changing one small parameter, we can change the sensitivity of the sensor itself."

Dr. Ledet reports a number of major breakthroughs with the sensor technology in the last eighteen months. Although the researchers are manually producing the sensor, they anticipate it will eventually be mass produced?driving the price down further.

###

About the Orthopaedic Research Society (ORS):

The Orthopaedic Research Society (ORS) is the pre-eminent organization for the advancement of musculoskeletal research. It seeks to transform the future through global multidisciplinary collaborations?focusing on the complex challenges of orthopaedic treatment. The ORS advances the global orthopaedic research agenda through excellence in research, education, collaboration, communication and advocacy. The ORS Annual Meeting and publication of the Journal of Orthopaedic Research provide vital forums for the musculoskeletal community to communicate the current state of orthopaedic research.

Home

[ | E-mail | Share ]

AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

Go here to see the original:
Orthopaedic smart device provides personalized medicine

The Everist CardioDefender device.

ANN ARBOR — Everist Genomics, a rapidly growing personalized medicine company, today announced that world-renowned scientist and genome sequencing pioneer J. Craig Venter will be the keynote speaker for its March 26th Gala Dinner at the Field Museum in Chicago.

Venter achieved global prominence in 2001 for being the first to sequence the human genome, accomplishing this feat two years in advance of the government-sponsored Human Genome Project and at a fraction of the cost. He received acclaim again in 2010 for leading a team of scientists to create the first synthetic life form, a single-cell bacterium known as Mycoplasma laboratorium. His contributions to the field of genomics — including the decoding of his own genome — have enabled the new era of personalized medicine, in which treatment of medical conditions are tailored to individual patients.

Venter, who was twice named to Time magazine’s list of the world’s 100 most influential people, founded the J. Craig Venter Institute, a research organization with more than 500 scientists and staff dedicated to human, microbial, plant, synthetic and environmental genomic research and the exploration of social and ethical issues in genomics. Venter is also founder of Synthetic Genomics Inc., a privately held company dedicated to commercializing genomic-driven solutions to address global needs such as new sources of energy, new food and nutritional products, and next generation vaccines. He was awarded the National Medal of Science in 2009, the highest honor awarded to scientists by the United States government.

In his speech, “A Celebration of the Science and Creativity Driving the New Era of Personalized Medicine,” Venter will discuss how breakthroughs in basic science research, such as genome sequencing, are paving the way for a new medical paradigm. This goal will become more attainable as the cost of genome sequencing continues to drop and advances in computational science provide stronger insights about the underlying connections between genes and human physiology.

“Personalized medicine is evolving at a rapid pace, maturing from what was once a vague concept debated in research labs to the defining characteristic of 21st Century healthcare,” said Thomas Everist, chairman of the board of directors of Everist Genomics. “The goal of our Gala is to provide the healthcare community with an opportunity to celebrate the advancements made over the last decade.   We are certain that Dr. Venter’s transcendent expertise in genomics, along with his adeptness as a speaker, will stimulate a thoughtful dialogue about the role that personalized medicine will play in improving care.”

Everist Genomics offers diagnostics, prognostics and therapeutic selection technologies. The company launched its first product last year with the introduction of OncoDefender-CRC, a prognostic test for predicting the risk of disease recurrence for early stage colorectal cancer patients. The company expanded its pipeline with the creation of a new franchise of diagnostic and prognostic tests aimed at melding personalized medicine with mobile health platforms. Everist Genomics mobile health diagnostics include CardioDefender, the world’s first hospital quality smartphone ECG system,  and AngioDefender, the first tablet computer to assist physicians in diagnosing atherosclerosis and cardiovascular disease in asymptomatic patients.

More at http://www.everistgenomics.com.

Read more from the original source:
Everist Genomics Celebrates Origins, Future of Personalized Medicine

NEWTON, MA--(Marketwire -02/08/12)- Recombinant Data, a healthcare data warehousing and clinical intelligence solutions provider, today announced that it was a finalist in the Most Promising Company Competition at the Personalized Medicine World Conference 2012 (PMWC). The award is presented by PMWC and Prescience International. Recombinant was selected from among 31 entrants and was the only software company among the top three finalists which included biotech companies Auxogyn and Epizyme. Winners were selected by a panel of judges and attendee voting.

According to Tal Behar, co-founder of PMWC, the Competition showcases some of the world's most promising personalized medicine innovations. "Customization of treatment, with all decisions and practices being tailored to the individual, will be a revolution of the current healthcare cycle. We look forward to seeing how the companies highlighted during this year's Competition will define the next generation of personalized medicine," said Behar.

The PMWC 2012 Most Promising Company award is conferred to companies with technology, products or services that are disruptive and innovative to the current standard-of-care, both in cost and effectiveness; strength of team and ability to execute; barriers to competition and strength of intellectual property; and expected financial returns for investors.

"Being a finalist in the Most Promising Company Competition highlights Recombinant Data's success in providing critical data infrastructure and analytics solutions to leading pharma and biotech companies, academic medical centers and healthcare delivery systems," said Peter Emerson, CEO of Recombinant Data. "Linking data from patient care, clinical research and basic life science research and having the ability to analyze and interpret that data is essential to advancing personalized medicine. Recombinant Data is committed to this goal."

"We congratulate Recombinant Data and all of the companies competing this year," said Melinda Richter, founder and CEO, Prescience International. "The quality of entries demonstrates that personalized medicine will play an increasingly significant role in delivering high-quality, cost-effective healthcare and it will continue to grow in importance as scientific breakthroughs are translated into a new generation of targeted therapeutics."

About Recombinant Data Corp.
Recombinant provides leading-edge data warehousing and clinical intelligence solutions to healthcare providers, academic medical centers and life science researchers to deliver higher quality outcomes, accelerate personalized medicine, and lower costs. Our team of industry veterans is focused on improving the flow of reliable data to power clinical and research applications in a secure, compliant environment. For more information about Recombinant's products and services, visit http://www.recomdata.com.

About Personalized Medicine World Conference
The Personalized Medicine World Conference, a two-day business and educational conference that provides real-world insights on how to succeed in producing and implementing personalized medicine, is produced by PMWC International is dedicated to transforming healthcare through the global adoption of personalized medicine.

About Prescience International
Prescience International is dedicated to accelerating the commercialization and global adoption of science and technology. With industry expertise in the future of technology markets, Prescience International creates and manages centers of excellence in the form of research parks, innovation centers, research foundations, research institutes and emerging companies.

Go here to read the rest:
Recombinant Data Named Finalist in Personalized Medicine World Conference 2012 "Most Promising Company" Competition

MENLO PARK, Calif., Feb. 9, 2012 /PRNewswire/ -- Auxogyn, Inc., a privately-held company advancing women's reproductive health, announced today that the Personalized Medicine World Conference (PMWC) and Prescience International selected the Auxogyn as the 'Most Promising Company' at PMWC2012 annual conference, held January 23-24, 2012.

"We are honored to be recognized by industry leaders and our peers as the most promising company for PMWC2012," said Lissa Goldenstein, president and chief executive officer of Auxogyn.  "We look forward to bringing the promise of personalized medicine to the field of assisted reproduction through Eeva, our proprietary non-invasive system that provides objective information on embryo viability to guide patient treatment paths."

Auxogyn was chosen from a group of 31 companies by a group of industry leaders including Paul Billings, M.D., chief medical officer, LIFE Technologies, Rowan Chapman, Ph.D., partner, Mohr Davidow Ventures, Edgar Engleman, M.D., managing partner, Vivo Ventures and Drew Senyei, M.D., managing director, Life Science Practice, Enterprise Partners, as well as audience polling.

"Auxogyn stood out among the presenting companies for its revolutionary approach to improving patient outcomes during in vitro fertilization (IVF) procedures and reproductive health as a whole," said Tal Behar, co-founder of the Personalized Medicine World Conference. "The ability to provide quantitative information for selection of embryos during IVF procedures holds unique promise for the millions suffering from infertility today. We expect novel products like Eeva to play an increasingly significant role in delivering high-quality, cost-effective healthcare in the years to come, and we extend our sincere congratulations to Auxogyn on this premier award."

To qualify for the Most Promising Company Award, a company must be privately-held and working the areas of therapeutics, diagnostics or platform and information technologies. Selection is based on how a company's innovation is disruptive to current standard-of-care, both in cost and effectiveness; strength of team and ability to execute; barriers to competition and strength of intellectual property and expected financial returns for investors.

About Eeva™

Auxogyn's non-invasive early embryo viability assessment (Eeva) system may improve assisted reproduction outcomes by providing IVF clinicians and patients with objective information on embryo viability.  Eeva's proprietary software automatically analyzes embryo development against scientifically and clinically validated cell-division timing parameters.  With Eeva's quantitative data on each embryo's potential development, IVF clinics may be able to select the best embryo(s) for transfer or optimize the treatment path for their patients undergoing IVF procedures. Auxogyn is completing a multi-center, 150-patient clinical trial to validate the safety and efficacy of Eeva, and plans to use the results of the study for regulatory filings in Europe and the United States in 2012.

About Auxogyn

Auxogyn, Inc. is focused on advancing the field of reproductive health through its uniquely-combined knowledge of early human developmental biology, advanced computer vision technology and best clinical practices. The company's first product, Early Embryo Viability Assessment (Eeva), provides quantitative information regarding embryo development, to assist IVF clinics in potentially selecting the best embryo(s) for transfer and optimizing the treatment path for their patients undergoing IVF procedures.  Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, TPG Biotech and Merck Serono Ventures. For more information regarding Auxogyn please visit http://www.auxogyn.com.

See the article here:
Auxogyn Takes Top Honor as 'Most Promising Company' at Personalized Medicine World Conference 2012

29-01-2012 18:01 Biomarkers in Depression, Anxiety and ADHD

View original post here:
Dr Evian Gordon - World Conference on Personalized Medicine 2012 (15 Minutes).mp4 - Video

01-02-2012 14:27 Theral Timpson, Host and Producer at Mendelspod.com shares his thoughts about the Personalized Medicine World Conference 2012 (PMWC2012), which was held in Mountain CA, USA (January 2012). The interview covers the company competition conducted during the PMWC2012 and discusses the winner of the 2012 First Prize - Auxogyn. Please leave your comments and questions on this page.

Here is the original post:
Review of the Personalized Medicine World Conference 2012 - Video

Enlarge image Siemens Signs First Personalized Medicine Diagnostics Deals

Guenter Schiffmann/Bloomberg

A sign sits on a wall outside the entrance to Siemens AG's headquarters in Munich.

A sign sits on a wall outside the entrance to Siemens AG's headquarters in Munich. Photographer: Guenter Schiffmann/Bloomberg

Siemens AG, Europe’s largest engineering company, is wading into the multibillion-dollar field of personalized medicine by announcing deals to develop companion tests with two drugmakers.

The Munich-based company will work with HIV drugmaker ViiV Healthcare Ltd. and Tocagen Inc., a developer of an experimental brain tumor treatment, to create tests that will determine which patients will benefit from the therapies, said Trevor Hawkins, head of Siemens’ next generation diagnostics division.

“This is a major step forward for us, moving into this multibillion market, which we haven’t been in up until today,” Hawkins said in an interview. “We have every expectation to now growth this much further beyond where we are.”

Personalized medicine involves determining whether a patient is genetically susceptible to a particular disease or would be especially responsive to certain treatments. These new therapies often require special genetic tests, which are being created by separate companies, in some cases.

Siemens, which makes products ranging from light bulbs to high-speed trains, is under increased pressure to keep up with competitors such as Basel, Switzerland-based Roche AG, which is attempting a hostile takeover of gene-mapping company Illumina Inc., Ben Uglow, an analyst at Morgan Stanley, wrote in a note to clients last month.

Molecular Diagnostics

The market for molecular diagnostics, which includes personalized medicine tests, will more than double in the U.S. to $5.5 billion in 2016 from its $2.5 billion size in 2010, according to TriMarkPublications.com.

ViiV, a venture between London-based GlaxoSmithKline Plc (GSK) and New York-based Pfizer Inc. (PFE), the world’s biggest drugmaker, has an HIV drug called Selzentry that works with patients that have a specific form of the virus. Siemens will develop a test to help doctors determine which patients would benefit from the therapy.

Tocagen, based in San Diego, is working on a treatment for glioma, or brain cancer, called Toca 511 that’s in early human trials. Working with Siemens will give the company more credibility in discussions with the Food and Drug Administration and a quicker approach in marketing if approved, said Harry Gruber, chief executive officer of closely held Tocagen.

Formal Process

“We realized you really have to have a company that could commercialize as part of your team during the registration studies,” Gruber said in an interview. “We went through a very formal process to interview all the major players in the companion diagnostics space, and from the very beginning, this is the team we jelled with.”

No financial details of the agreements were disclosed.

Siemens, Roche and Abbott Laboratories (ABT) are seeking to form partnerships with drugmakers to develop these companion tests, said David Parker, vice president of the consulting firm Boston Healthcare.

“The test makers are all out there talking with potential pharma partners,” Parker, based in Washington, said in an interview. “I think we’re going to see nothing but an increase in the frequency in which drugs and diagnostics come to market.”

The pace of such approvals has accelerated, said Gwen Gordon, a spokeswoman for the Personalized Medicine Coalition, an industry advocacy group based in Washington. More than 72 such therapies are available today, a fivefold increase from the 13 available in 2006.

“In the past, it had been a much more difficult process to get the drug and the diagnostic approved, because there’s different people at the FDA that work on each set of products,” Gordon said. Now, the groups are coordinating more as drugmakers recognize the market’s potential. “They recognized that there is a market for tailored therapies for patients that know that the drug is going to work.”

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Read the original here:
Siemens Signs First Agreements for Personalized Medicine Diagnostics

TORONTO, Feb. 6, 2012 (GLOBE NEWSWIRE) -- GeneNews Limited (TSX:GEN.TO - News), a molecular diagnostics company focused on developing blood-based biomarker tests for the early detection of diseases and personalized health management, today announced that it has signed a memorandum of understanding ("MOU") with Shanghai Biochip Co. Ltd. ("SBC"), a leading Chinese engineering centre for advanced microarray and gene expression profiling technologies, to enter into a strategic alliance to establish the first Sentinel Centre for Personalized Medicine in China.

GeneNews and SBC would jointly establish and manage the Sentinel Centre for Personalized Medicine to co-develop and commercialize additional products based on GeneNews' proprietary platform technology, the Sentinel Principle(R). In addition, the MOU sets forth the main criteria to be incorporated into definitive development, distribution and license terms under which SBC would obtain non-exclusive rights to market and sell GeneNews' ColonSentry(TM) test in China. A formal agreement will be negotiated and executed before the end of the Company's third fiscal quarter. Financial terms were not disclosed.

"We are focused on bringing leading edge technologies to the people of China to improve healthcare outcomes," stated Dr. Yuchen Chen, Director, Business Development of SBC. "We are looking forward to working with GeneNews to establish the world's first Sentinel Centre for Personalized Medicine to advance the development and commercialization of innovative, non-invasive tests targeted at early disease detection in China."

"Shanghai Biochip's expertise in gene expression profiling platforms and well-established clinical network provide a strong foundation for us to jointly establish a state-of-the-art research and development core capability in China that is aligned with our pipeline development and commercialization objectives. We look forward to building a successful strategic alliance with Shanghai Biochip," said Gailina J. Liew, President & Chief Operating Officer of GeneNews.

The Sentinel Principle(R), a platform technology discovered and developed by GeneNews, is based on the concept that all clinical conditions and body states, including those resulting from disease or in response to treatment, generate characteristic gene expression signatures in the blood as a result of the constant and dynamic physiological interaction of blood with the cells, tissues and organs of the human body. This technology is the basis of GeneNews' initial product, ColonSentry(TM), the world's first blood test for colorectal cancer, and the SentinelGx(TM) suite of services. GeneNews' broad global patent portfolio includes issued foundational patents and pending patents in diverse disease areas such as cancer, cardiovascular, neurological and inflammatory conditions.

About Shanghai Biochip

Shanghai Biochip is a national engineering centre for advanced microarray and gene expression profiling technologies in China that has developed a strong network of academic, clinical and medical partners to utilize its expertise and services as a contract research organization and bio-banking facility.

About GeneNews

GeneNews is an emerging molecular diagnostics company focused on the application of functional genomics to enable early diagnosis and personalized health management based on disease-specific biomarkers. The Company has a patented core platform technology, the Sentinel Principle(R), which has the power to detect and stage virtually any disease or medical condition from a simple blood sample. GeneNews is currently applying the Sentinel Principle(R) in major areas with unmet clinical needs such as cancer, arthritis, cardiovascular disease and neurological disorders. GeneNews' lead product, ColonSentry(TM), is the world's first blood test to pre-screen and assess an individual's current risk for colorectal cancer. For more information on GeneNews and ColonSentry(TM), go to http://www.GeneNews.com or http://www.ColonSentry.com.

Forward-Looking Statements

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.

More here:
GeneNews Enters Into MOU With Shanghai Biochip to Establish First Sentinel Centre for Personalized Medicine