Point-of-Care Technologies
Clinicians often place a great deal of blind faith in the results of IVD medical devices. Staff assumes if a device gives a result, then that result must be correct. Glucose meters, pregnancy tests, blood gas analyzers and coagulation devices are all considered equivalent to central laboratory instrumentation, only faster. Yet, central laboratory testing is conducted under well monitored and controlled conditions, while these point-of-care testing (POCT) devices are subjected to a variety of...
  HiberGene Diagnostics CEO Tony Hill As part of our new monthly series on emerging IVD companies, IVD Technology spoke with Tony Hill, CEO of HiberGene Diagnostics Ltd., a young company based in Dublin, Ireland. Hill's company has developed a rapid and highly sensitive molecular diagnostic test for bacterial meningitis, which the company hopes to introduce to the European market in Quarter 4 of this year, with a U.S. introduction a year later.   Please give us...
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...
When Jennifer went to her endocrinologist after almost three years of living with a mysterious nexus of symptoms and a large differential diagnosis, her doctor put an iPad in her hands. For years, she was accustomed to going months between tests and receiving single, typewritten, numeric results. This system was replaced by high-frequency diagnostics combined with data that she was acquiring and managing herself. Since her last visit, Jennifer had been mailing dried capillary blood spots to a...
A two-tiered regulatory scheme currently imposed on sponsors of new point-of-care (POC) IVDs, particularly devices intended for the physician office laboratory (POL), was characterized as unduly burdensome in a column titled, “CLIA-Waived Tests: Is There Another Way?” published in the March/April 2010 issue of IVD Technology. In brief, a prospective sponsor of a new POL test not only must secure FDA clearance but, in many cases for marketing reasons, also must obtain CLIA...
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...
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...
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-...
Molecular diagnostics, POC diagnostics, and hematology are expected to see continued growth. The current IVD market includes immunochemistry, molecular diagnostics, blood donor screening, hematology, hemostasis, and point-of-care testing. As the IVD market evolves to become more efficient and less costly, a shift from manual testing to automated methods is essential. Furthermore, as patient care shifts from the hospital to the alternate care setting, IVD is likely to follow. Overall...
Samsung Electronics Company, Ltd., a globally recognizable brand of semiconductor, telecommunication, digital media, and digital convergence technologies based in Seoul, South Korea, has acquired the Nexus division of ITC Nexus Holding Company (ITC), a provider of cardiac point-of-care testing products. Nexus, based in San Diego and founded not quite three years ago, manufactures and markets the Cardiac STATus, DECISION Point, and VYENT lines of rapid test kits that aid in the diagnosis and...