Employment or Leadership: None declared. Consultant or Advisory Role: A.S. Jaffe, Beckman Coulter, Critical Diagnostics, Inverness Medical, Radiometer, Pfizer, and Amgen. Stock Ownership: None declared. Honoraria: A.S. Jaffe, Roche and Abbott Laboratories. Research Funding: A.K. Saenger, Roche Diagnostics; G.G. Klee, Beckman Coulter; A.S. Jaffe, Beckman Coulter. Expert Testimony: None declared....