 |  | | San Francisco Chronicle: Early warning system for drug dangers sought | [show details] |
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| San Francisco Chronicle, March 21, 2008
If one company's disaster can transform an industry, the withdrawal of Merck's $2.5 billion painkiller Vioxx in 2004 may become the textbook example.
Primarily, the removal of Vioxx from the market due to heart risks spurred a sweeping examination of the pharmaceutical industry and its regulation. But it also enriched the soil for a new generation of companies trying to update technology that detects whether new drugs may be harmful to the heart.... To read the entire article online, please visit http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/03/21/BU9RVK360.DTL&hw=singulex&sn=001&sc=1000 |
| | | Drug Discovery & Development: Adding ‘Omics to Clinical Trials | [show details] |
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| Drug Discovery & Development, February 1, 2008
...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....
To read the entire article online, please visit http://www.dddmag.com/Article-Genomics-and-Proteomics-Tools-Can-Improve-Clinical-Trials.aspx
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| In 2004, the U.S. Food and Drug Administration released a white paper, now known as the Critical Path Initiative, which challenged the pharmaceutical industry to reduce the time (12–15 years) and expense (approximately $1–2 billion) required to bring a drug to market. Biomarkers were seen as key to meeting this challenge with a promise of providing more effective drug and target identification, safety and toxicity monitoring, and patient identification and stratification. With unprecedented sensitivity and dynamic range, the technology described in this article helps fulfill the promise of biomarkers through its advances in single molecule detection. |
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| 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
- academic and industry partnerships in diagnostic assay development
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| OVERVIEW: Early identification of adverse heart events is invaluable—not only in clinical diagnostic settings, but in clinical trials as well. The Singulex Erenna Immunoassay System detects small changes in concentration levels of cTnI well below the current and standard detectable limit of all other Troponin assays. In fact, the assay is able to measure the level of troponin I in normal individuals—something Singulex president Philippe Goix says has never been possible before. With the cTnI assay and other similarly sensitive assays, Singulex looks to improve clinic diagnostics as well as helping pharmaceutical companies prevent late-stage drug development failures. Download complete article.... |
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| Alan H. Wu, Ann Q. Lu, Bob Freese, John A. Todd
American Association of Clinical Chemistry, Annual Meeting 2007;
Abs No. A-46.
doi:10.1016/j.ahj.2007.10.016 [PMID: 18215588]
Poster presented at AACC 2007. ABSTRACT: The European Society/American College of Cardiology (ESC/ACC) have established cardiac troponin (cTnI) as the gold standard for diagnosis of acute myocardial infarction (AMI) and risk stratification for adverse cardiac events. We previously reported the development of a highly sensitive cTnI assay and the use of this assay to define cTnI levels in normal subjects. This assay has been further developed to yield greater sensitivity and currently we report its analytical and preliminary clinical performance. |
| | | Single molecule troponin detection to assess for transient myocardial ischemia | [show details] |
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| Sabatine MS, Morrow DA, Lu QA, de Lemos JA, Jarolim P, Todd JA, Braunwald E.
American Heart Association Scientific Sessions 2007; Abs No. 12183.
doi:10.1016/j.ahj.2007.10.016 [PMID: 18215588] |
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| Alan H. Wu, Ann Q. Lu, Bob Freese, John A. Todd
American Association of Clinical Chemistry, Annual Meeting 2007;
Abs No. A-46.
doi:10.1016/j.ahj.2007.10.016 [PMID: 18215588]
8.5 x 11" version of poster presented at AACC 2007. ABSTRACT: The European Society/American College of Cardiology (ESC/ACC) have established cardiac troponin (cTnI) as the gold standard for diagnosis of acute myocardial infarction (AMI) and risk stratification for adverse cardiac events. We previously reported the development of a highly sensitive cTnI assay and the use of this assay to define cTnI levels in normal subjects. This assay has been further developed to yield greater sensitivity and currently we report its analytical and preliminary clinical performance. |
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| Development and preliminary clinical validation of a high sensitivity assay for cardiac troponin using a capillary flow (single-molecule) fluorescence detector. Cardiac troponin (cTnI) is the gold standard for diagnosis of myocardial infarction (AMI) and risk stratification for adverse cardiac events. [Abstract for Oak Ridge Conference]. |
