The clinical utility of a molecular test rises proportional to a favorable regulatory risk/benefit assessment, and clinical utility is the driver of payer coverage decisions. Although a great deal has been written about clinical utility, debates still center on its 'definition.' We argue that the definition (an impact on clinical outcomes) is self-evident, and improved communications should foc...

OBSERVATION Outbreak situations require in vitro diagnostics (IVDs) to identify those who are infected and to track the infectious agent in the population. However, such IVDs are typically not available and must be developed. In addition, the process of IVD development, assessment, and implementation are very time and resource intensive. Recognising the extraordinary public health need for IVDs...

Several model-based seasonal adjustment diagnostics are currently being incorporated into X-13-ARIMASEATS, a new hybrid seasonal adjustment program under development at the U.S. Census Bureau. These diagnostics have been implemented in the Ox programming language, and this paper discusses various aspects of the implementation. The diagnostics are normalized quadratic forms in the data, and roug...

Area: Diagnostics for future burning tokamak devices and stellarators. Benefit: An opportunity to develop compelling technology in the area of plasma diagnostics allowing internal field, n e and T e measurements on next step tokamaks and stellarators. Questions: 1) What can the US do in regards to ITER and DEMO to allow us to be an integral player, to play a bigger role? 2) Our importance withi...

tmRNA^anovel high-copy-numberRNAdiagnostic target ^ its application forStaphylococcus aureus detection using real-timeNASBA Justin O’Grady, Katrina Lacey, Barry Glynn, Terry J. Smith, Thomas Barry & Majella Maher The Biomedical Diagnostics Institute Program, National University of Ireland Galway, Galway, Ireland; Molecular Diagnostics Research Group, National Centre for Biomedical Engineering S...