Point-of-Care Technologies
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...
NIH offers grant funding for IVDs
    TRENDS & PERSPECTIVES     As part of the American Recovery and Reinvestment Act that was passed by Congress and signed into law by President Obama in February, NIH has designated for the next two years at least $200 million for a new initiative called the NIH Challenge Grants in Health and Science Research. This initiative will fund 200 or more grants, contingent upon the submission of a sufficient number of scientifically meritorious applications. In addition, the...
Developing point-of-care A1c tests for diabetes monitoring
            Point-of-care A1c analyzers provide immediate results, facilitating patient education and consultation, and improving patient compliance. With a worldwide annual growth rate of approximately 15%, point-of-care (POC) testing is one of the fastest-growing segments of the IVD market. Advances in technology have resulted in fast, easy-to-use assays that offer laboratory-quality results in minutes. The number of POC tests continues to grow...
Magnetic immunoassays: A new paradigm in POCT
            Figure 1. (click to enlarge) Characteristic M = M(H) for a superparamagnetic material. The advantages of using magnetic beads as labels in bioassays have been well established. Magnetic beads are not affected by reagent chemistry or photobleaching and are therefore stable over time. In addition, the magnetic background in a biomolecular sample is usually insignificant, and magnetic beads can be manipulated remotely by magnetism. A...
Developing an optically stimulated piezofilm immunoassay
            The point-of-care (POC) or near-patient test market remains a strong growth area in the IVD industry.1 Two of the main factors driving growth in diagnostic POC testing are convenience and a compelling need to know. In today's digital age, society has become more impatient, demanding information as soon as possible. Consequently, patients can walk into a pharmacy or physician's office and have their cholesterol levels measured while they wait....
Strong growth projected for POC products
          The potential growth of the point-of-care (POC) diagnostics market during the next five years is discussed in “Worldwide Market and Emerging Technologies for Point-of-Care Testing,” a report published by InteLab Corp. (Mission Viejo, CA). The study highlighted the individual sectors in the international POC market, such as hospital bedside, home/self-testing, and physician's office lab (POL), and the factors affecting its development. The report...
Developing rapid mobile POC systems, Part 2: Nucleic acid-based testing platforms
          Figure 1. The FluoSens sensor (top). The 90-g optoelectronic unit is implemented in a housing as a commercial product (bottom). The appearance of methicillin-resistant Staphylococcus aureus (MRSA) has led to a crisis in hospitals throughout the developed world, and the pathogen is increasingly being recovered from nursing homes and the general community.1 MRSA is responsible for many deaths and a significant cost burden to the...
Developing rapid mobile POC systems Part 1: Devices and applications for lateral-flow immunodiagnostics
Figure 1. (click to enlarge) A 90-gram optoelectronic unit (a) and detail of the engineered interior (b) is the core of the handheld and mobile systems by ESE Embedded System Engineering GmbH (Stockach, Germany). The unit includes two excitation sources and two detectors for different wavelengths. The need for better emergency diagnostics and epidemiological preparedness, along with high healthcare costs, has increased the demand for affordable...
Lateral-flow POC tests to grow
        Table I. (click to enlarge) Combined worldwide sales of over-the-counter and professional lateral-flow point-of-care tests by category: 2005 (actual), 2010 (projected). Source: Kalorama Information (New York City). The lateral-flow point-of-care (POC) test market is expected to grow steadily and increase by more than 40% in five years. According to a report by Kalorama Information (New York City), titled “Lateral-Flow Technology and...