Business Strategy
On June 13, the Supreme Court issued its long-awaited decision in Association for Molecular Pathology v. Myriad Pharmaceuticals, Inc. In a 9-0 decision, the Court ruled that naturally occurring human genes are not patent-eligible subject matter under the U.S. Patent Act, but cDNA can be patented. The Court did not address Myriad patents covering genetic testing methods based on specific mutations in human genes. The full decision is available online. The Myriad decision has caused a fair degree...
Stephen Lundy of Venaxis Inc. (formerly AspenBio Pharma) Any parent who has rushed to Urgent Care with a toddler shrieking in abdominal pain will appreciate the big opportunity Stephen Lundy saw when he became head of Venaxis Inc. (formerly AspenBio Pharma). A 25-year veteran of the IVD industry, Lundy says the market potential of the appendicitis blood test that the company was developing lured him from his CEO post at MicroPhage to Venaxis’s Colorado headquarters. When Lundy...
The former Idaho Technology Inc. now sports a new name and a new logo. The former Idaho Technology Inc., a Salt Lake City−based manufacturer of diagnostics for the clinical, biodefense, and research markets, has renamed itself BioFire Diagnostics Inc. and is in the process of rebranding, a task vice president of sales and marketing Rachel Jones estimates will take 12 months from start to finish. The company was formed in Idaho Falls, Idaho, in 1990 but moved to its current...
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...
When developing an IVD device, typically the first thing that comes to mind is the assay: what is the sample being tested for and how is the target detected? This is the central thinking of most companies, whether they are setting out to extend a product’s lifespan or to bring a disruptive new technology to market. However, while the assay is core, focusing exclusively on this can significantly minimize the potential market scope and lead to commercial failure. In this article we will...
  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...
The Clinical Lab Expo will feature new science and technology in every area of clinical diagnostics, automation, information systems, point of care, OEM, and biotech. Roughly 750 organizations will occupy about 2000 booths. According to Clinical Lab Expo's Website, "You will see more products in every clinical lab discipline than at any other show." Find What You Need The Clinical Lab Expo will have special sections for special products. Visit the special sections for point-of-...
The late Angus Maddison, an economist from the University of Groningen, compiled data that suggests China and India were the biggest economies in the world for almost all of the past 2000 years. They only lost this position during the Industrial Revolution. It now appears that China will regain its place as the world’s largest economy, overtaking the United States, sometime during the next decade.1 The IVD markets of China and India, two countries that account for approximately one-third...
Nonclinical diagnostic applications are typically more loosely regulated than their clinical counterparts, which is attractive to manufacturers. However, working effectively in nonclinical markets requires that manufacturers know what their nonclinical clients are seeking, what technology is required, and whether and how the final product is going to be used long-term. To learn more about the benefits and challenges of working in nonclinical diagnostics, IVD Technology editor Richard Park spoke...
Last December, PwC released a new report, “Diagnostics 2011: M&A Surges, Companion Diagnostics Accelerate, and Early Detection Offers New Prospects.” This report provides an overview of merger and acquisition deal activity in the IVD industry during the past two years and the factors driving it, an assessment of the development of new prospects for early detection testing, and a review of significant events for the development of personalized medicine. The report also...