Detection Technologies
Enhancing assay performance using nanoscale detection
Most immunodiagnostic and nucleic acid detection methods have in common the use of a solid surface onto which a bioactive reagent is coated, such as an antibody, antigen, or oligomeric probe. Such biomolecules are complex long-chain structures possessing optimal three-dimensional conformation with specific loci for binding sites or epitopes. However, the conventional deposition of bioactive molecules onto solid surfaces is an inefficient and random process. For example, while antibodies can...
Automated image analysis for developing IVDs
With the promise of personalized medicine and effective targeted molecular therapeutics on the horizon, developing translational IVDs that can accurately select patients for specific therapies or treatment regimens has become more critical. Two of the best known examples in oncology are the examination of estrogen receptors and HER2 expression using immunohistochemistry (IHC) to predict the response to tamoxifen and Herceptin, respectively (see Figure 1). As a measurement of expression in fixed...
Rapid detection of non-radioactive GFR markers
Chronic kidney disease (CKD) is a major medical problem in the United States and the rest of the world. In 2008, a 30% increase in CKD cases during the past decade prompted the U.S. Renal Data System (USRDS) to issue for the first time a separate report documenting the magnitude of the disease, which affects an estimated 27 million (or one in ten) Americans and accounts for more than 24% of Medicare costs.1 An earlier report also estimated that at least 20 million more people are at risk for...
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...
Advances and challenges in detection technology
              Christopher Cooney, PhD, is director of engineering at Akonni Biosystems (Frederick, MD). He oversees the development of an on-chip PCR microarray flow cell, a microarray imager, a thermal cycler, an automated sample-prep device, and a point-of-care sample-to-answer microarray instrument. He has worked in microfluidics and biosensors for 10 years. Cooney can be reached at cooney@akonni.com. New developments in detection...
Lateral-flow assays using time-resolved luminescence
    Detection Technologies         While the consumer IVD market has undergone tremendous growth in recent years, it has been primarily dominated by glucose monitoring tests. A limited number of other types of IVD products are available on the over-the-counter (OTC) consumer market, and many of them can generate only qualitative test results for a small number of conditions. In order to expand the OTC market, the desired IVD products in this market need to...
Evolving detection technology methods
            Randy White, PhD, is chief executive officer of Adnavance Technologies Inc. (Vancouver). He has 35 years of ex­perience in medical diagnostics and laboratory operations. Prior to joining Adnavance, he served as chief executive officer for two molecular diagnostics companies, Nanogen (San Diego) and Xenomics (New York City), where he spearheaded the commercialization of technologies and launched eight molecular diagnostic products. He can...
Electrochemical detection-based DNA microarrays
Figure 1. The eSensor XT-8 system by Osmetech Molecular Diagnostics (Pasadena, CA). Until recently, multiplex technology, such as real-time polymerase chain reaction (PCR), could analyze only a small number of polymorphisms in a single test. The multiplexing capabilities of DNA microarrays have improved, thereby increasing the number of independent genotypes that can be determined simultaneously. Early microarrays focused on high-density applications that...
Building next-generation diagnostics
          Shuqi Chen, PhD, is the founder and chief executive officer of IQuum Inc. (Boston). IQuum's lab-in-a-tube technology is based on his vision and approach to biological sample processing. A former faculty member at Harvard Medical School, Chen received a PhD in medicine from Hadassah Medical School at Hebrew University (Jerusalem, Israel). He can be reached at shuqi@iquum.com. The long journey of polymerase chain reaction (PCR) technologies from...
Using integrated magnetic microchip devices in IVDs
          A prototype magnetic biosensor system by Diagnostic Biosensors LLC (Minneapolis) and NVE Corp. (Eden Prairie, MN). Photo by Roni Ramos Micro- and nanosized magnetic particles are commonly used in biochemical assays as a means to capture, concentrate, and manipulate target analytes. They are also increasingly used as detection labels for assay readout. These detection applications benefit from the large magnetic-field signature...