Volume 19

Winter 2013, Volume 19, No. 1
Winter 2013 issue of IVD Technology print publication
• The IVD Miniaturization Paradigm: n/a
• Three Strategies for Assessing IVD Instrument Feasibility Early in the Design Process: n/a
• Innovations in Anatomic Pathology Lab Automation
• EU IVD Regulation: Something Wicked This Way Comes?
• Predicting a Positive Outcome for a Negative-Predictive Appendicitis Test: n/a
• Approval Trends for Biomarker-Based IVDs: n/a

Volume 18

November/December 2012, Volume 18, No. 6
• Point-of-Care Molecular Diagnostic Testing
• Ten Economic Motivators for Patient-Centric Diagnostics
• A Modular Approach to Customizing IVD Instruments: n/a
• Proposed Guidance on IVD Clinical Evidence and Performance Evaluation: n/a
• CLIA-Waived Tests: Continuing the Conversation
• New IVD-Reimbursement Bill Introduced on Capitol Hill
• Idaho Technology Becomes BioFire Diagnostics, Advances Clinical Diagnostics Goals
May/June 2012, Volume 18, No. 3
• Ventana Strikes Numerous Deals With Pharma Firms This Year: n/a
• Manufacturing and Processing: Simplification and Flexibility Are Key
March/April 2012, Volume 18, No. 2
• China and India: Comparing Two Fast-Growing IVD Markets: n/a
• Nonclinical Diagnostics: Biodefense and Beyond: n/a
• Developing a Separation Matrix for Measuring Percent HbA1c: n/a
• Bill proposes modernizing IVD regulations: n/a
• FDA To Exempt Some IVDs from 510(k) Clearance
• Report offers insights into IVD M&A activity: n/a
• Samsung Electronics Lengthens its Dx Reach
• Measuring Regulatory Effectiveness
January/February 2012, Volume 18, No. 1

• Knowledge and experience diversity for IVD innovation
• Sourcing clinical patient samples for IVD development: n/a
• The challenges of developing hematology instruments
• TB CDRC Fights TB with Diagnostic Science
• Developing IVD Instruments: Complex But Rewarding
• Examining IVD-related election year issues
• Sony Buys Micronics, Extends IVD Reach
• Industry associations discuss mutually important issues: n/a
• OCD’s “Know Your Numbers” campaign pushes forward : n/a
• IVD Performance Evaluation Studies: Part 1

Volume 17

July/August 2011, Volume 17, No. 4

• Improving dispense accuracy in IVD instruments
• Workflow analysis and performance evaluation of an automated blood testing system
• Market access for cardiac point-of-care testing in the UK National Health Service
• Technological and Regulatory Developments in Point of Care: n/a
• Revision of Europe’s IVD Directive 98/79/EC: n/a
• IT Innovations Raise the Bar for IVDs : n/a
• FDA scrutinizes DTC genetic tests: n/a
• Gen-Probe: Seeking Buyer?: n/a
• Seegene to collaborate with Samsung: n/a
May/June 2011, Volume 17, No. 3

• Process monitoring: reducing costs and improving quality
• A kidney injury biomarker initiative
• 2011 MDEA winners in the IVD category
• Detection Technology: Where It Stands and Where It’s Headed
• Exploring FDA-Approved IVDMIAs
• AdvaMedDx Advocates for Industry
• Thermo Fisher Scientific buying and selling
• Lukewarm Response to FDA’s Proposed Innovation Pathway
• Goldman Sachs initiates coverage of IVD companies
• Patent Reform To Benefit IVD Industry
March/April 2011, Volume 17, No. 2
• Adapting the lateral-flow immunoassay format for detecting enzyme activity
• New paradigms for micropumps for consumable and permanent applications
• Innovation helping to personalize medicine
• Nonclinical Diagnostics: Adapting Clinical Technologies to Applied Testing
• Quality Control in Molecular Diagnostics
• Measuring Regulatory Effectiveness
• Congress Passes Food Safety Law
• Danaher Acquires Beckman Coulter
• Cepheid earns WHO endorsement of rapid TB test
January/February 2011, Volume 17, No. 1

• Pumps for IVD instruments: Controlling flow too small to see
• The Coulter Principle and the development of IVDs
• Challenges involved in technical transfer of assay manufacturing
• The State of Instrument Development
• Enhancing IVD Packaging Efficiency
• Examining the election fallout
• GE Acquires Clarient: In vivo meets in vitro
• Aetna supports study on genetic tests
• Report: POL tests will enable more efficient diagnoses

Volume 16

November/December 2010, Volume 16, No. 7

• Bacteriophage amplification for bacterial identification
• Portable real-time PCR for rapid viral identification
• Assessing the IVD markets of Brazil and Mexico
• Why manufacturers should embrace error grids
• FDA on Personalized Medicine
• The glass that is half-empty is also half-full
• FDA looks into regulation of LDTs, finally
• More M&As in IVD industry
• Report shows continued growth for India’s IVD market
• Direct-to-consumer genetic testing under scrutiny
October 2010, Volume 16, No. 6

• The Year in IVDs
• Introduction to Biochemicals and Chemical Reagents
• Introduction to Filters, Membranes, and Bioseparation Equipment
• Introduction to Assay System Components
• Introduction to Tools for Molecular Diagnostics
• Introduction to Electronic and Mechanical Components and Software
• Introduction to Packaging and Labeling Materials and Components
• Introduction to Manufacturing Equipment and Supplies
• Introduction to Contract Manufacturing
• Introduction to Consulting Services
August/September 2010, Volume 16, No. 5

• 15th Anniversary Roundtable: IVD Past, Present, and Future: Three Experts Weigh In
• 15th Anniversary Essay: Looking Back: An Overview of the Last 15 Years in IVDs
• 15th Anniversary Essay: Instrumentation and Automation
• 15th Anniversary Essay: Assay Development
• 15th Anniversary Essay: Molecular Diagnostics: A 15-Year Perspective
• 15th Anniversary Essay: Point-of-Care Testing
• 15th Anniversary Essay: Regulation Then and Now
• 15th Anniversary Essay: Looking Back: A Review of International IVD Regulations
• 15th Anniversary Essay: Looking Back: The Challenge of Companion Diagnostics
• 15th Anniversary Essay: Marketplace and Business Issues
• 15th Anniversary Essay: Detection Technologies
• 15th Anniversary Essay: The Future
July 2010, Volume 16, No. 4

• Improving lab automation by applying mechatronics
• Developing a point-of-care mass spectrometer
• Monitoring biomarkers in fluids and bodies of water
• Regulation of IVDs in Australia
• AACC's Industry Division
• The Problem of Regulatory Uncertainty
• Court rules gene patents invalid
• Creation of Genetic Testing Registry Is Underway
• Challenges for comparative effectiveness research in IVDs
May/June 2010, Volume 16, No. 3

• Automated image analysis for developing IVDs
• Enhancing assay performance using nanoscale detection
• IVD category winners in the MDEA competition
• Manufacturing and Processing Go High-Tech
• Laboratory Quality Control Based on Risk Management
• Improving OIVD transparency
• Healthcare reform to benefit IVDs
• Radiological devices oversight moves to OIVD
• Merck Group buys Millipore
• SACGHS draft report finds gene patents unhelpful
• New venture capital fund established for biotech
March/April 2010, Volume 16, No. 2

• Using recombinant monoclonal antibodies to develop IVDs
• Pressure-sensitive adhesive tapes for IVD applications
• Rapid detection of non-radioactive GFR markers
• Nonclinical diagnostics for biowarfare testing
• A taxonomy for medical device use error
• CLIA-waived tests: Is there another way?
• Inverness stays in acquisition mode
• Strong M&A activity expected for IVD industry
• AdvaMed creates new IVD division
• Growth and challenges for personalized medicine
• Assessing the future of immunoassays

January 2010

• Industry action leads to tax reduction
• VC funds: Some good news for biotech
• Lewin Group report bolsters IVD’s credibility
• Finding success through the IVD product definition process
• Manufacturing obstacles in IVD product development
• Microfluidics for IVD analysis: triumphs and hurdles of centrifugal platforms, Part 2: Centrifugal microfluidics
• The Case for Regulating Laboratory-Developed Tests
• Consolidation & connectivity in instrument development
• Promises and challenges of companion IVDs for oncology