DX Directions: Advanced Assay Technologies and Development Methods

Various market reports and studies have concluded that the future for immunoassays is a mixed bag. In the clinical laboratory, mature assays will show moderate growth while emerging assays will fuel most of the growth in this IVD segment. However, all immunoassays will have to pass the test of medical research to demonstrate their contributions to improving patient outcomes. For example, increased knowledge of disease physiology derived from molecular biology and human genome studies will enhance the position of analytes used in chronic conditions such as cardiovascular disease, autoimmune disorders, and diabetes. The function of genes is measured by the presence of tangible products, such as proteins of every size and molecular structure. Thus, immunoassays combined with DNA probe studies will have an important place in post-genomic medicine.

This special report will include the following feature articles:

• Developing a Raman Detection System for Immunoassays
  Describes the Raman detection and quantification of a commonly used biological marker protein, peroxidase.
  Authors: Samar Kundu, Neal Siegel, and Charles Ginsburgh of Sword Diagnostics (Summit-Argo, IL)
   
• Developing Lateral Flow Assays with an Image-Based Analyzer
  Discusses how an independent measurement system, along with assay-specific calibrations and software algorithms can be used during assay development in his article.
  Author: Scott Dylewski of Alverix Inc. (San Jose, CA)
   
• Enzyme Conjugates for IVD Applications
  Reviews the various chemical strategies for creating enzyme-antibody conjugates, and discusses aspects of conjugation processes that effect quality, consistency, scalability, and cost, along with a new conjugation technology that simplifies the production of IVD reagents.
  Author: Nick Gee of Innova Biosciences Ltd. (Cambridge, UK)