Related to Real-Time Sample Prep on the Horizon

• 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.
  
• The $1,000 Genome: From Laboratory to Lifestyle
  How we resolve current issues with genetic testing will shape consumer genomics.
  
• 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.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance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.
  
• 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.
  
• 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.
  
• 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.
  
• 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.
  
• Enabling the Future of Plant Biology
  Plant genomics impacts crop productivity, biodiversity, and climate change and is of increasing importance worldwide.
  
• 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.
  
• Patient Privacy or Scientific Advances: Do They Have to Be Mutually Exclusive?
  Presidential Commission weighs pros and cons of making sequencing data available to researchers and patients.
  
• Jury Is Still Out Over Disclosing Genomic Research Findings to Patients
  While most agree that biobanks share responsibility, how to decide what details to reveal is up for debate.
  
• Why Biomarker Discovery Is Hard
  Differentiating which markers are in the driver’s seat and which are along for the ride is key.