In Person
Predicting a Positive Outcome for a Negative-Predictive Appendicitis Test
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...
Cultivating a POC Ecosystem
On the eve of the 2012 AACC Annual Meeting in Los Angeles, IVD Technology quizzed Peter Koerte, vice president of global Peter Koerte, PhD, is vice president, global marketing, Point of Care business unit, Siemens Healthcare Diagnostics, since 2011. In 2007, Koerte joined Siemens’ corporate headquarters in Munich, Germany, as director of Strategic Transformation. Koerte received a master’s degree in industrial engineering from the Karlsruhe Institute of Technology in Germany...
POC IVD Platform Seeks Partners to Leverage Double-Digit Growth
Diarmuid Flavin, CEO of Biosensia, has 15 years of management experience in the healthcare industry, from diagnostics to medical devices and sterile parenteral pharmaceutical manufacture. Previously, he was quality operations manager for cardiac therapies at Abbott Vascular. Flavin is a graduate of the National University of Ireland and holds an MSc in pharmaceutical manufacturing technology, a higher diploma in QA assurance, and a BSc in microbiology. Irish startup Biosensia will...
Manufacturing and Processing: Simplification and Flexibility Are Key
Doing more with less is a goal of manufacturing across all industries, including companies making IVDs. Manufacturers want to make high-quality products in large volumes but with simpler, more-streamlined machinery, and with less waste. To learn more about the current state of manufacturing and processing technologies in the IVD industry, Richard Park spoke with Sharon Bracken, Divisional Vice President, Global Operations, Diagnostics at Abbott. IVD Technology: What have been the most...
Nonclinical Diagnostics: Biodefense and Beyond
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...
Developing IVD Instruments: Complex But Rewarding
Gen-Probe's Panther system Developing an amplified molecular instrument is challenging. It is a time-consuming and costly endeavor for manufacturers, and the end result must be a highly reliable, robust instrument. Add in the regulatory hurdles and issues related to marketing the product worldwide, and the task seems almost insurmountable. To learn more about how such challenges are overcome and why the benefits of developing such instruments are worth the costs, IVD Technology editor...
Companion Diagnostics: A Blossoming Field
Companion diagnostics are emerging as a key part of personalized medicine. Particularly in oncology, patients are being better served by drugs for which patients are selected via in-vitro diagnostic tests. The field is promising but nascent: so far, the potential of companion diagnostics is greater than the number of drug-and-diagnostic products that is actually commercially available. To find out why this is the case, and to learn more about the future of companion diagnostics, IVD...
Technological and Regulatory Developments in Point of Care
Point-of-care testing is present---in varying degrees---in every hospital in the United States. Blood-glucose tests, pregnancy tests, and radiology-related tests, for example, are commonplace and virtually indispensible. Molecular diagnostics for infectious-disease testing are becoming more widespread as well. With all of these technological advances come greater and more complicated regulatory scrutiny. FDA, CMS, and CDC are all keeping watchful eyes on the point-of-care testing market. To...
Detection Technology: Where It Stands and Where It’s Headed
In the field of detection technology, advances in multiplexing and the increasing emphasis on point of care are of primary importance. Trends include nonenzymatic and isothermal approaches for nucleic-acid testing, which reduce the complexity of very complicated molecular assays. The primary challenge right now is the front-end automation: sample acquisition and preparation. To learn more about what’s new in detection technology, IVD Technology editor Richard Park spoke with John C....
Nonclinical Diagnostics: Adapting Clinical Technologies to Applied Testing
The markets for molecular applied testing provide ample opportunity for growth. While human identification and forensics are established molecular marketplaces, the food- and animal-testing markets are now seeing molecular technologies gaining ground over traditional immunological tests. Across all segments of applied testing, customers are asking for the same thing: highly reliable, complete workflow solutions that produce results of the highest quality. To learn more about the current trends...