Related to Abbott Nabs Distribution Rights to Biofortuna’s Freeze-Dried HLA Typing Kits

• Clinical Trial Failures Further Signal Pancreatic Cancer’s Intractable Nature
  Researchers need to step out of the gemcitabine box and also take on the development of diagnostics for early detection.
  
• Jumping On Genetic Testing—The War of the SNPs
  Molecular diagnostics still have a long way to go before they can properly deliver on all their promises.
  
• PEPs Gaining FDA Nod but Remain Hard to Take
  Pancreatic enzyme replacement therapies may be the answer to lowering the pill burden for patients.
  
• Getting Personal: Multigene Testing for Individual Cancer Evaluation
  Scientists find comfort in numbers, using molecular patterns as prognostic markers.
  
• 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.
  
• Tumor Cells Back in Circulation for Monitoring Cancer
  With one test on the market, researchers are developing tools that leverage CTCs as biomarkers.
  
• Biotechs Hop on Cloud Nine with Better Resources Gained from New Technology
  Companies large and small are seeing benefits as cloud-based services get fine-tuned for the life sciences.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance
  Among potential changes is that manufacturers will have to anticipate customers’ intended use of their IVD products.
  
• Therasense v. Becton Dickinson Ruling Expected to Limit Inequitable Conduct Cases
  Becton has until August 23 to file an appeal with the U.S. Supreme Court.
  
• 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.
  
• Personalized Medicine Initiatives Step Into the Cloud to Speed Up R&D
  Drug developers see advantages in handling and interpreting data generated by large-scale next-gen sequencing.
  
• 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.
  
• Standardization Key to Taking Next-Generation Sequencing to the Next Level
  As NGS technology makes steady progress with faster and cheaper machines, regulation will have to keep up.