Point-of-Care Technologies
Designing Medical Device Software for the Millennial
2010 was a catalyst year for computing. When Apple launched the iPad tablet computer in April, it brought the keyboard and mouse one step closer to extinction. Similarly, with Windows 7, Microsoft added true touch-screen support to desktops, tablet PCs, and smartphones. Google made an entrance as well, with Android, an operating system for smart phones and slates. Touch screen will be the dominant user interface for years to come, according to DisplaySearch.com, which monitors and reports on...
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...
Market access for cardiac point-of-care testing in the UK National Health Service
The National Health Service (NHS) is the universal public healthcare system that is delivered free at the point of access throughout the United Kingdom.1 It operates within all four regions: England, Scotland, Wales, and Northern Ireland.1-3 An estimated 75% of U.K. healthcare is delivered through the NHS, with the remaining 25% delivered by the private sector.2 The NHS is run by the Department of Health and funded through general taxation. Hence, there is no patient reimbursement mechanism in...
New paradigms for micropumps for consumable and permanent applications
Point-of-care (POC) test systems and infusion pumps are two key areas in which microfluidic technologies are used. POC systems are used for analysis, diagnosis or screening, and sample preparation, in which an assay technology and the corresponding detection method are brought together in miniaturized formats on microfluidic platforms. Infusion pumps provide continuous, long-term delivery of various fluids. For all of these processes, fluid handling is required. This article discusses a...
Cepheid earns WHO endorsement of rapid TB test
Cepheid’s Xpert MTB/RIF test won the endorsement of the World Health Organization (WHO) last December. The test has the potential to revolutionize TB care and treatment by accurately diagnosing patients in about 100 minutes—a huge reduction in time to results compared to conventional TB diagnosis, a WHO representative said in a press statement. Cepheid (Sunnyvale, CA) is offering a 75% discount on the price of the test and the table-top computer system that goes with it to...
Report: POL tests will enable more efficient diagnoses
A report issued by  Kalorama Information (New York City) characterizes the physician-office-lab (POL) testing market as “wide and diverse as one can imagine” and “an emerging tool for more efficient diagnosis and patient evaluation.” The report, “Physician Office Laboratory Markets,” published in November 2010, analyzes how the market for POL testing has evolved since 2007. It places the world market for POL diagnostics in 2009 at an estimated $2 billion...
15th Anniversary Roundtable: IVD Past, Present, and Future: Three Experts Weigh In
In vitro diagnostics is, by many accounts, an underrated, undervalued industry. While pharmaceutical and therapeutic medical-device innovations tend to garner most of the mainstream media’s attention, the fact remains that 60 to 70% of medical decisions are influenced by some type of diagnostic testing, yet diagnostics accounts for only a tiny fraction of overall healthcare spending.  Some of the major developments within this very important industry during the past 15 years include...
15th Anniversary Essay: Point-of-Care Testing
The catch-all term point-of-care (POC) testing covers an enormous range of tests in a diverse range of settings (e.g., home, doctor’s office, bedside, developing world). The main focus of this article will be the technologies behind POC testing, primarily those technologies used for immunoassay tests. Most IVD industry experts would agree that POC testing will slowly gain greater market share and that, in particular, this is a one-way street. Tests rarely migrate back to the central lab...
Promises and challenges of companion IVDs for oncology
Several conferences held last summer provided a basis for the notion that a relative gold rush of companion diagnostics in oncology is nearing reality. However, cancer biomarkers also present unique complexities for the lab industry, regulators, and physicians. The American Society for Clinical Oncology (ASCO) focused its 2009 meeting on the idea that a personalized medicine approach must become the standard for effective clinical oncology. Three years ago, Her-2/neu stood...
Better and faster: Improving rapid point-of-care testing
Most of today's lateral-flow assays rely on a small-pore chromatographic medium, such as nitrocellulose, to facilitate the movement of liquid-based specimens through a narrow three- dimensional space. Location dependent binding sites are applied to the membrane, which the analytes and detection reagents bind to. Such binding sites can be specific (e.g., a specific antibody for the analyte in question) or generic (e.g., a capture reagent such as streptavidin in which the capture antibody has a...