Related to Microfluidics Device that Assesses Her2 Status from Circulating Tumor Cells Developed

• 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.
  
• 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.
  
• Roche Takes a Stab at Getting mAbs Under the Skin
  Firm is testing Herceptin SC in Phase III and expects to couple it with a user-friendly delivery device.
  
• 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.
  
• Is Avastin Roche’s Achilles Heel?
  Label-expansion efforts have failed, and mAb stands to lose provisional approval in breast cancer.
  
• 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.
  
• Timing Is Everything in Studying Disorderly Proteins
  Scientists are developing methods to catch these molecules in the act of folding and transitioning.
  
• Genentech Prepares to Vouch for Avastin’s Use in Breast Cancer in FDA Hearing
  Company will present details on a so-called confirmatory study and biomarker data.
  
• 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  Agency issued draft guidance on companion diagnostic approval on July 14.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.
  
• 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.
  
• Avastin Label Changes Reignites Debate: Is OS or PFS the Better Regulatory Endpoint?
  A recent panel discussion set the stage for defining standards for drug approval as separate from those for treatment decisions.
  
• 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.
  
• 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.
  
• Enzo Sues Roche, Gen-Probe, and Life Technologies in Patent Infringement Case
  Patent under dispute expires in 2023, and defendants plan on fighting the lawsuit.
  
• Myriad, Prometheus Continue to Defend Diagnostic Patents while Others Urge More Licensing
  Battle raged on at second USPTO hearing tasked with evaluating the impact of patents on the availability of confirmatory tests.
  
• Lawyers Offer Predictions for Myriad, Diagnostic Field Based on Supreme Court’s Decision Against Prometheus
  Advice focuses on ensuring transformative steps are included in claims.
  
• With USPTO Report Near, Comments Reflect Confirmatory Diagnostic Testing Divide
  Dx makers would like to keep patent protection, but patient groups say it stifles broader access to genetic tests at lower cost.
  
• Resolving Pharmacological Responses
  A new microfluidic approach can dramatically increase the number of data points per compound during screening.