Related to Standardization Key to Taking Next-Generation Sequencing to the Next Level

• The Underappreciated Cost-Saving Potential of Personalized Medicine in Health Reform Debate
  The current draft includes comparative effectiveness research but does not provide nearly as much funding as is needed for CER.
  
• Avastin: Time for a Predictive Test
  Roche’s strategy to expand the use of Avastin into the first-line and adjuvant settings is particularly dependent on identifying those most likely to see a benefit.
  
• Biomarkers Poised for Breakout Moment
  A passel of discussions at BIO highlight the importance of these disease-state indicators.
  
• Human Genome Redux: Just a Numbers Game?
  Success of sequencing capabilities is dependent on tools to analyze the data.
  
• 2010 in Review: Biotechnology Highlights
  Gene patenting and ESCs were back in the headlines along with breakthroughs in sequencing, syn bio, and other fields.
  
• Beckman Coulter on the Chopping Block?
  Some analysts believe it is not a question of who will buy the firm but if the firm will be bought.
  
• Biotechs Nail Down Sequence of Elusive E. coli
  A new hybrid strain is responsible for the European outbreak that’s been all over the news.
  
• Concurrent Dx/Rx Review Will Require More Collaboration at FDA and More Outreach by Industry
  Agency issued draft guidance on companion diagnostic approval on July 14.
  
• Companies with Cancer Therapeutic Candidates Ramp Up Companion Diagnostic Efforts
  As regulatory framework gets fine-tuned, firms realize the importance of having a biomarker strategy.
  
• Prometheus and Myriad Case Outcomes Will Help Shape the Future for MDx Businesses
  Courts’ current decisions suggest that special attention will need to be paid to performing and claiming transformative steps in biomarker-based tests.
  
• Product and Service Firms Challenged by Uncertain NIH Funding, Polarization of Sequencing
  Analysts and vendors are preparing for low to no growth in 2012 and 2013.
  
• Exome Sequencing Finds Sweet Spot Between Whole-Genome and Targeted Sequencing
  Technique provides a cost-effective tool for dissecting diseases that have been intractable to conventional gene discovery.
  
• Amicus Filings in Prometheus v. Mayo Reflect Divide Over Diagnostic Method Patentability
  Supreme Court has to decide whether to reverse previous stance upholding two of Prometheus’ method patents.
  
• USPTO Tasked with Evaluating Impact of Gene Patents on Second-Opinion Testing
  Diagnostic firms argue IP protection is key to innovation, while their opponents say it hurts medical practice.
  
• R&D Direction in 2012 for Sequencing Technologies Is Aimed at Clinical Medicine
  Companies are focused on making these platforms smaller and easier to use.
  
• Sequencing Firms Set Up Centers to Advance Genomics Research and Instrument Sales
  Strategy provides a feedback loop to improve instrumentation and develop new applications.
  
• Academic Sequencing Centers May Feel the Pinch of Budgetary Constraints and Data Deluge
  NHGRI renewed $416 million over four years in funding for three centers but warned of lower funds in the future.
  
• Presidential Panel Wrestles with Ethical Issues Linked to Clinical Use of Whole Genome Sequencing
  Final recommendations, to be presented this fall, will encompass technology delivery and informed consent.
  
• Debate over Patenting Genes at Forefront of First Hearing on Second Opinion Testing
  Hearing was part of a study required by the new patent system to assess the impact of gene patents on obtaining confirmatory tests.
  
• Sequencing in the Dark
  Analysis of Life Technologies’ Ion Torrent sequencing platform points to significance of photon-free technology.