Related to Debate over Patenting Genes at Forefront of First Hearing on Second Opinion Testing

• Tumor Cells Back in Circulation for Monitoring Cancer
  With one test on the market, researchers are developing tools that leverage CTCs as biomarkers.
  
• Gene Patents in Europe Relatively Stable Despite Uncertainty in the U.S.
  European law makes it clear that isolated DNA is patentable, and major changes are not expected.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance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.
  
• 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.
  
• 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.
  
• 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.
  
• 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.
  
• This Time Last Year: Diagnostic Deals, mAb Therapeutics, and Obesity Drug Development
  Among big news was Roche’s companion diagnostic alliance with Clovis, a melanoma deal with BMS, and FDA’s Avastin decision.
  
• With Briefs Due June 15, Myriad Fires First Shot in Circuit Rematch Over Gene Patenting
  Firm asked appeals court to dismiss the case because the sole plaintiff’s standing has changed since he left NYU.
  
• LAVAgel for Protein Diagnostics
  Researchers introduce a microfluidic, single-channel, multistage immunoblotting strategy toward scalable protein isoform analysis.
  
• Genome Testing Reduces Overtreatment
  Study after study has shown that molecular diagnostics can help oncologists more effectively treat patients.
  
• 7 Biotech Trends for the Coming Year
  What does 2013 hold for the industry?
  
• 10 Predictions That Will Transform Healthcare
  Peer into GEN's crystal ball for a glimpse of what's to come.
  
• Detecting Acquired Drug Resistance in Cancer
  New methods allow noninvasive analysis in blood plasma.
  
• Your Genes, Your Choice?
  Critics say the American College of Medical Genetics and Genomics’ recent recommendations for reporting incidental clinical sequencing results undermine patient autonomy.
  
• Moving Genomics Closer to the Clinic
  Foundation Medicine and Memorial Sloan-Kettering Cancer Center are working to translate genomic information into personalized cancer treatment.
  
• 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.
  
• 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.
  
• 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.
  
• 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.