IVD Industry Overview
James Donnelly IVD leader Siemens Healthcare Diagnostics Inc. is sending one of its executives, James Donnelly, PhD, to Philadelphia next week to deliver a not-to-be-missed keynote speech at MD&M East. His talk will kick off the "Design for Speed" session on Day 2 of the conference and is part of the Design & Prototype track. Those in the IVD industry who are attending the conference are urged to attend this talk, which is "related directly to diagnostic...
Contract manufacturing is generally defined as the production of goods or services by one company under the label or brand name of another company. Contract manufacturers (CMs) may provide such services to several organizations based on customer (or CM-generated) designs, formulas, and/or specifications. Contract manufacturing is a form of outsourcing. Companies that use contract manufacturers range in size from one to several thousand employees. CMs are usually hired to perform specialized...
Did you know: Diagnostics R&D spending is 10 times the average among U.S. industries? Diagnostics can decrease healthcare-associated staph infection rates by 70%? 4000 IVD tests are currently available for clinical use? These impressive IVD-industry facts and others are presented on the AdvaMedDx infographic "Diagnostics Transforming Care," which originally appeared (and is still available) on the AdvaMedDx website and has been posted here with permission of AdvaMedDx. If you...
  An integrated MEMS-microfluidics sensor device (actual size). Green printed circuit board layers support a silicon chip and acrylic microfluidic interface. A four-tube (850-micrometer Tygon) interface is attached to the right side. IVD technology is following a path trod by many other industries: as product sizes decrease, the level of integration increases. Integration allows the same machine or person to handle a smaller yet higher-level system using the same or smaller...
Anyone keeping an eye on the IVD industry during the past 12 months or so could likely rattle off a series of significant developments: Roche’s failed attempt to acquire Illumina might top one’s list of notable IVD news, or possibly Hologic’s recent acquisition of Gen-Probe. New partnerships between IVD and pharmaceutical companies forged in pursuit of drug-diagnostic test combinations-Dako and Genentech, Abbott and Merck, and Ventana Medical Systems reaching out to several...
Table 1. Capillary flow times for Hi-Flow Plus membranes. *The range is for all measured values on a roll and represents ±3∂. The acceptable range for the mean is ±10% of the target.   Selecting, evaluating, and sourcing critical raw materials is a strategic step in the development and production of diagnostic kits. This is also a strategic task for company management, because an IVD company always must optimize its return...
IVD technology continues to advance, adding new biomarker detection capabilities, refined sample sensitivity, and test applications in areas such as food safety, animal health, and infectious diseases. As they keep pace with these changes, suppliers of membranes and filters emphasize that buyers for these components must understand certain fundamental requirements if they are to get the most out of their assays. Assay efficiency requires the diagnostic device to use a membrane “that is...
  Antigen used in immunoassay kit manufacture being shipped on dry ice. Image: The Binding Site   Without question, the reagents used in diagnostic testing assays are one of the most fundamental and critical components necessary for a medical laboratory to properly function. Without them, a laboratory ceases to operate, as it is unable to generate the necessary tests required for the diagnosis, treatment, and monitoring of a patient’s condition. When...
Most in vitro diagnostic (IVD) assays require biochemical and chemical reagents to make them run. To meet this requirement, IVD manufacturers initially developed and produced the reagents (i.e., the controls, blocking solutions, buffers, washers, substrates, antibodies, and so forth). This approach afforded ultimate control over supply of these critical assay components, but came with its own price. IVD manufacturers needed to invest their finite resources in reagent product development,...
  Shopping for parts, components, services, and new technologies at the Clinical Lab Expo next week? You're in luck. Here's just a tiny sampling of what will be on display there. Isolation Miniature Valves Solenoid-operated valves use a flexible diaphragm to isolate the solenoid actuation mechanism from the fluid path. When the valve is energized, the solenoid retracts an armature that is attached to a flexible diaphragm. In a normally closed valve, this raises the diaphragm, allowing...