Johnson & Johnson
Oct 3, 2007

Ortho-Clinical Diagnostics Introduces Improved Sensitivity Troponin I Assay To Help Diagnose Heart Attack, Heart Damage

Enhances Immunodiagnostic Cardiology Menu

Raritan, NJ (October 1, 2007) – Ortho-Clinical Diagnostics, a Johnson & Johnson company, announces the availability in the United States, Europe and other international markets1 of an improved sensitivity troponin I assay. The biomarker troponin I is used along with other cardiac tests to help diagnose a heart attack and to detect and evaluate heart injury. It may also be used to predict the risk of having a future coronary event.

Heart attacks are a major cause of mortality in the world. Physicians require accurate cardiac troponin results to aid in the diagnosis of heart attacks or cardiac injury. Therefore, troponin assays with improved sensitivity can be useful in identifying patients earlier and those most likely to benefit from specific therapeutic interventions.

In 2000 the Joint European Society of Cardiology/American College of Cardiology Committee (ESC/ACC)Consensus Document described cardiac troponin as the preferred biomarker for heart damage because of its sensitivity and specificity for heart tissue.2 The VITROS® Troponin I ES Assay quantitatively measures cardiac troponin I in human serum and plasma with the level of sensitivity and precision described in the ESC/AAC consensus document, improving the ability to differentiate between healthy and unwell patients.

The VITROS® Troponin I ES Assay is designed and integrated with the VITROS® ECi /ECiQ System to help ensure quality, accurate results using Intellicheck® technology. Excellent precision is demonstrated across the Troponin I ES Assay measuring range. The assay demonstrates precision and sensitivity at the normal decision level (99th percentile of a normal population) that meets the ESC/ACC guideline for acceptable imprecision in a high sensitivity troponin I assay. The assay performance and integration with the VITROS® ECi /ECiQ Immunodiagnostic System provides confident results, true improvements in workflow and turnaround times, improved labor efficiency and effectiveness.

The VITROS® Troponin I ES Assay complements the VITROS® ECi /ECiQ Immunodiagnostic System's existing cardiology offering of NT-proBNP, CK-MB and Myoglobin.

About the VITROS® ECi/ECiQ Immunodiagnostic System

The VITROS® ECi/ECiQ Immunodiagnostic System is a simple to use, flexible and fully automated laboratory testing system that provides true continuous, STAT, random access capabilities for routine and specialty immunodiagnostic testing. The system uses proprietary enhanced chemiluminescence detection technology to provide excellent assay performance including wide dynamic ranges and exceptional precision and sensitivity. The VITROS® ECi/ECiQ Immunodiagnostic System also uses Intellicheck Technology, a proprietary technology designed to verify diagnostic checks throughout automated sample and assay processing. Intellicheck serves to increase the integrity and security of reported patient results while helping to ensure greater confidence and productivity for laboratories that generate these results.

The expanding VITROS® ECi/ECiQ Immunodiagnostic System test menu now includes over 45 tests worldwide for the sensitive measurement of thyroid function, reproductive health and fertility, bone metabolism, anemia, metabolic, oncology, emergency cardiology, and infectious diseases.

About Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world's blood supply. In addition, through its VITROS® MicroSlide™ and enhanced chemiluminescence technologies, the company has transformed the way that clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions and services that promote effective diagnoses and enhance patient care. For more information, visit

1 Product availability subject to fulfillment of regulatory requirements in each market.

2 Joint European Society of Cardiology/American College of Cardiology Committee. Myocardial Infarction Redefined–A Consensus Document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. J Am Coll Cardiol. 36: 959-969; 2000.