Archives
Fact-Check: Clarifying the Myriad Genetics Supreme Court Decision for Industry
Thomas M. Cooley Law School professor and registered patent attorney David C. Berry explains the Myriad Genetics Supreme Court decision and its implications for industry.
(June, 2013)
Siemens Chief Scientific Officer Donnelly to Kick Off "Design for Speed" Track at MD&M East Conference
The Siemens CSO insists "innovation" alone won't get IVD companies where they want to be. Meeting customer needs and making continuous quality improvements are key to making innovation pay off.
(June, 2013)
Fundamentals of Contract Manufacturing
Strategic outsourcing can reduce costs and provide access to expertise that is not available in house.
(June, 2013)
Boom Times for China’s IVD Market
Poised to become the world’s largest IVD market, China is a tremendous business opportunity for foreign companies, as long as they choose their partners wisely.  
(May, 2013)
Top 10 Molecular Diagnostics Companies
Top 10 list of molecular diagnostics companies based on molecular-related revenues in 2012.
(May, 2013)
A Risk-Management Roadmap for Clinical Laboratories
Any IVD device can and will fail under certain circumstances. CLSI EP 23 helps labs to manage and mitigate risk. Manufacturers also stand to benefit from knowledge of the guidelines.
(May, 2013)
In Case You Missed It: Infographic Highlights the Value of IVDs
If you haven't seen it already, take a look at AdvaMedDx's "Diagnostics Transforming Care" infographic, and share it with colleagues, customers, and other IVD stakeholders.
(April, 2013)
At HiberGene, Molecular Diagnostics Tackles Meningitis
A two-year-old IVD company in Dublin plans to commercialize a molecular diagnostic test for bacterial meningitis by the end of 2013.
(March, 2013)
Your Osteoporosis Test Is in the Nail
Crescent Diagnostics will soon launch a mail-in test that measures keratin levels in nail clippings as a surrogate marker for collagen, an indicator of bone quality.
(February, 2013)
The IVD Miniaturization Paradigm
MEMS fluidic interface standards advance miniaturization of IVD technology and integration of specialized electronic devices.
(February, 2013)
Innovations in Anatomic Pathology Lab Automation
Process reengineering combined with automation improves productivity, reliability, and provider and patient safety.
(February, 2013)
EU IVD Regulation: Something Wicked This Way Comes?
Everybody welcomes the adoption of risk-based classification rules based on GHTF guidelines, but too few people realize that this will represent a fundamental change in the way that IVD products are regulated.
(January, 2013)
Three Strategies for Assessing IVD Instrument Feasibility Early in the Design Process
Optimal architecture design enhances rapid product development and product performance.
(January, 2013)
Approval Trends for Biomarker-Based IVDs
Approval trends for biomarker-based IVDs are among the best objective measures of progress in advancing personalized medicine.  
(January, 2013)
Predicting a Positive Outcome for a Negative-Predictive Appendicitis Test
An acute need for an appendicitis test attracted an IVD industry veteran to a Colorado firm with promising blood-based technology.
(January, 2013)
Point-of-Care Molecular Diagnostic Testing
A target-dependent activation step is combined with isothermal amplification, helicase-dependant amplification, and DNA array-based detection on modified silicon chips to create a visually detectable signal.
(December, 2012)
Idaho Technology Becomes BioFire Diagnostics, Advances Clinical Diagnostics Goals
BioFire's VP of sales and marketing offers IVD Technology readers an inside look at the company's major re-branding effort.  
(December, 2012)
A Modular Approach to Customizing IVD Instruments
By adopting a modular OEM approach, the rapid-test or private-label manufacturer can avoid investing in an R&D program that requires a time-to-market commitment.
(November, 2012)
Ten Economic Motivators for Patient-Centric Diagnostics
IVD manufacturers who adapt to the new patient role by making consumer-friendly devices or simplifying sample collection will remain competitive.
(November, 2012)
CLIA-Waived Tests: Continuing the Conversation
There is a need to revisit whether the current regulatory scheme is the most appropriate approach to ensuring both the safety and effectiveness of POL IVDs and facilitating their availability and utilization.
(November, 2012)
Proposed Guidance on IVD Clinical Evidence and Performance Evaluation
Manufacturers of IVD devices should be aware of three proposed Global Harmonization Task Force guidance documents on clinical evidence for IVD devices.
(November, 2012)
The Year in IVDs
Industry giants and smaller players launched IVD products and technologies this past year aimed at improving automation, decreasing operator involvement, offering point-of-care analysis, decreasing time to test result, and more.
(October, 2012)
Tools for Molecular Diagnostics: Redefining the Clinical Laboratory
Molecular methods have revolutionized the way clinical labs perform testing. Here's what IVD manufacturers need to know about this game-changing field. (This essay appears as the introduction to the "Tools for Molecular Diagnostics" section of the 2012-2013 annual buyers guide.)
(October, 2012)
How To Choose Assay System Components for Your IVD
This essay appears as the introduction to Section 3, Assay System Components, in our 2012-2013 Buyers Guide.
(October, 2012)
The New EU IVD Regulation Is Here: Fasten Your Seatbelts, and Get Ready for the Ride
The long-awaited and perhaps feared new EU text that will regulate all in vitro diagnostic products on the EU market has arrived.
(October, 2012)
Fact-Check: Clarifying the Myriad Genetics Supreme Court Decision for Industry
Thomas M. Cooley Law School professor and registered patent attorney David C. Berry explains the Myriad Genetics Supreme Court decision and its implications for industry.
(June, 2013)
Siemens Chief Scientific Officer Donnelly to Kick Off "Design for Speed" Track at MD&M East Conference
The Siemens CSO insists "innovation" alone won't get IVD companies where they want to be. Meeting customer needs and making continuous quality improvements are key to making innovation pay off.
(June, 2013)
Fundamentals of Contract Manufacturing
Strategic outsourcing can reduce costs and provide access to expertise that is not available in house.
(June, 2013)
Boom Times for China’s IVD Market
Poised to become the world’s largest IVD market, China is a tremendous business opportunity for foreign companies, as long as they choose their partners wisely.  
(May, 2013)
Top 10 Molecular Diagnostics Companies
Top 10 list of molecular diagnostics companies based on molecular-related revenues in 2012.
(May, 2013)
A Risk-Management Roadmap for Clinical Laboratories
Any IVD device can and will fail under certain circumstances. CLSI EP 23 helps labs to manage and mitigate risk. Manufacturers also stand to benefit from knowledge of the guidelines.
(May, 2013)
In Case You Missed It: Infographic Highlights the Value of IVDs
If you haven't seen it already, take a look at AdvaMedDx's "Diagnostics Transforming Care" infographic, and share it with colleagues, customers, and other IVD stakeholders.
(April, 2013)
At HiberGene, Molecular Diagnostics Tackles Meningitis
A two-year-old IVD company in Dublin plans to commercialize a molecular diagnostic test for bacterial meningitis by the end of 2013.
(March, 2013)
Your Osteoporosis Test Is in the Nail
Crescent Diagnostics will soon launch a mail-in test that measures keratin levels in nail clippings as a surrogate marker for collagen, an indicator of bone quality.
(February, 2013)
The IVD Miniaturization Paradigm
MEMS fluidic interface standards advance miniaturization of IVD technology and integration of specialized electronic devices.
(February, 2013)
Innovations in Anatomic Pathology Lab Automation
Process reengineering combined with automation improves productivity, reliability, and provider and patient safety.
(February, 2013)
EU IVD Regulation: Something Wicked This Way Comes?
Everybody welcomes the adoption of risk-based classification rules based on GHTF guidelines, but too few people realize that this will represent a fundamental change in the way that IVD products are regulated.
(January, 2013)
Three Strategies for Assessing IVD Instrument Feasibility Early in the Design Process
Optimal architecture design enhances rapid product development and product performance.
(January, 2013)
Approval Trends for Biomarker-Based IVDs
Approval trends for biomarker-based IVDs are among the best objective measures of progress in advancing personalized medicine.  
(January, 2013)
Predicting a Positive Outcome for a Negative-Predictive Appendicitis Test
An acute need for an appendicitis test attracted an IVD industry veteran to a Colorado firm with promising blood-based technology.
(January, 2013)
Point-of-Care Molecular Diagnostic Testing
A target-dependent activation step is combined with isothermal amplification, helicase-dependant amplification, and DNA array-based detection on modified silicon chips to create a visually detectable signal.
(December, 2012)
Idaho Technology Becomes BioFire Diagnostics, Advances Clinical Diagnostics Goals
BioFire's VP of sales and marketing offers IVD Technology readers an inside look at the company's major re-branding effort.  
(December, 2012)
A Modular Approach to Customizing IVD Instruments
By adopting a modular OEM approach, the rapid-test or private-label manufacturer can avoid investing in an R&D program that requires a time-to-market commitment.
(November, 2012)
Ten Economic Motivators for Patient-Centric Diagnostics
IVD manufacturers who adapt to the new patient role by making consumer-friendly devices or simplifying sample collection will remain competitive.
(November, 2012)
CLIA-Waived Tests: Continuing the Conversation
There is a need to revisit whether the current regulatory scheme is the most appropriate approach to ensuring both the safety and effectiveness of POL IVDs and facilitating their availability and utilization.
(November, 2012)
Proposed Guidance on IVD Clinical Evidence and Performance Evaluation
Manufacturers of IVD devices should be aware of three proposed Global Harmonization Task Force guidance documents on clinical evidence for IVD devices.
(November, 2012)
The Year in IVDs
Industry giants and smaller players launched IVD products and technologies this past year aimed at improving automation, decreasing operator involvement, offering point-of-care analysis, decreasing time to test result, and more.
(October, 2012)
Tools for Molecular Diagnostics: Redefining the Clinical Laboratory
Molecular methods have revolutionized the way clinical labs perform testing. Here's what IVD manufacturers need to know about this game-changing field. (This essay appears as the introduction to the "Tools for Molecular Diagnostics" section of the 2012-2013 annual buyers guide.)
(October, 2012)
How To Choose Assay System Components for Your IVD
This essay appears as the introduction to Section 3, Assay System Components, in our 2012-2013 Buyers Guide.
(October, 2012)
The New EU IVD Regulation Is Here: Fasten Your Seatbelts, and Get Ready for the Ride
The long-awaited and perhaps feared new EU text that will regulate all in vitro diagnostic products on the EU market has arrived.
(October, 2012)