News and Press

We introduce here our highly sensitive immunoassay for troponin I. We are beginning to see the next generation of assays that can report measurable troponin concentrations in healthy subjects. Our Erenna® immunoassay system measures as little as 1.7 ng/L of troponin I with 10% CV, and the 99th percentile in a group of apparently healthy subjects was 7 ng/L.

Already playing first chair among tests used to detect acute myocardial infarction, cardiac troponin may have other instrumental roles in its future. New, more sensitive troponin assays on the near horizon hold the promise of improving diagnosis in acute coronary syndrome, as well as risk stratifying patients in numerous settings, including potentially primary care.

Proteins are the machinery that drive most biological processes: however, measuring their concentrations at low levels has been historically impeded by a lack of appropriately sensitive technology. Advances in immunoassay technology, such as single molecule counting, have provided orders of magnitude of increased sensitivity. These novel technologies are enabling new discoveries and a clearer understanding of previously intractable biology. Here we discuss how single molecule counting technology can brighten the future of translational research, drug discovery and personalised medicine.

...Some companies also improve existing assays. Singulex, Hayward, Calif., for example, developed a technique for single-molecule detection that “extends the dynamic range of immunoassays by one to two orders of magnitude,” says Philippe Goix, PhD, chief executive officer. “If you have an immunoassay, we can quickly integrate it into our platform without drastically changing it.” Singulex is already developing ways to use this technology in clinical trials. For one thing, its high sensitivity could measure normal levels of hard-to-measure proteins, and then look for changes after administering a drug during a clinical trial....

A tremendous amount of progress has been made in developing assays. Most of these advances have been in genomic level disease-screening assays that provide yes/no answers. Because one gene can trigger the formation of many different proteins, protein biomarkers offer a wealth of valuable information for clinical development and monitoring. The challenge is to produce robust proteomic assays that are also clinically validated. In this article, IVD editor Richard Park and Singulex president Philippe Goix discuss:

• the biggest recent technological advances and trends in diagnostic assay development
• how IVD companies go from biomarker discovery to commercially viable products
• pharmacogenomics in assay development: present and future
• primary challenges for IVD manufacturers developing diagnostic assay products