Ortho Clinical Diagnostics Receives FDA Approval For New HIV Test

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 31 Mar 2008 - 0:00 PDT

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Ortho-Clinical Diagnostics announced U.S. Food and Drug Administration approval of a new diagnostic assay for the detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti HIV-1 and anti HIV-2). The new VITROS® Anti-HIV 1+2 assay1 can be run in a fully automated, random access format on the VITROS ECi/ECiQ Immunodiagnostic System, with results readily available in less than 50 minutes. This FDA approval and availability to laboratories in the U.S., Puerto Rico and U.S. territories marks the first anti-HIV 1+2 test capable of being run in full random access with other tests and providing immediate result reporting capability upon test completion. VITROS Anti-HIV 1+2 tests can be run at any time, in any order and with other types of tests. The features of automation and random access can increase productivity and efficiency in the laboratory.

The VITROS Anti-HIV 1+2 assay can help meet the demand on laboratories created by new U.S. Centers for Disease Control and Prevention (CDC) testing recommendations. The CDC now recommends routine, voluntary HIV testing in all health care settings, including health clinics and emergency rooms, for all individuals ages 13 to 64 without written informed consent. In addition, testing is recommended at least once a year for those at high risk.2

By latest estimates, approximately 1,039,000 to 1,185,000 people in the United States are living with HIV/AIDS, with 24 to 27 percent undiagnosed and unaware of their HIV infection.3 Costs associated with unrecognized or late-recognized HIV infection are growing.

Two multicenter research teams supported in part by the National Institute on Drug Abuse, National Institutes of Health, have independently determined through the development of computer models that routine screening for HIV in health care settings is as cost effective as screening for other conditions such as breast cancer and high blood pressure, and can provide important health and survival benefits. The studies also suggest that screening that leads to a diagnosis of HIV infection may further lower health care costs by preventing high-risk practices and decreasing virus transmission.4

The VITROS Anti-HIV 1+2 Assay has been co-developed with Chiron, a business of Novartis Vaccines and Diagnostics Inc.

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 more than 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 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 http://www.orthoclinical.com.

References

1 Refer to the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack and VITROS Products Anti-HIV 1+2 Calibrators Instructions for Use for Warnings and Limitations

2 CDC. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 2006; 55 (No. RR-14):1-17.

3 Glynn M, Rhodes P. Estimated HIV prevalence in the United States at the end of 2003. National HIV Prevention Conference; June 2005; Atlanta. Abstract 595.

4 http://www.drugabuse.gov/newsroom/05/NR2-09.html

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