Siemens receives FDA approval for HIV-1 test on Automated Molecular Instruments

Siemens Healthcare received approval from the U.S. Food and Drug Administration (FDA) to sell its VERSANT^® HIV-1 RNA 3.0 viral load test in the United States, for use on the automated VERSANT^® 440 Molecular System. This approval allows clinical laboratories to benefit from running an FDA-approved HIV-1 and hepatitis C virus (HCV) test on one single viral load testing platform. Viral load testing is a quantitative method critical to monitoring a patient’s infection and therapy.

“HIV-1 and HCV are among the most requested infectious disease tests in the United States,” said Dr. David Okrongly, senior vice president, molecular diagnostics, Siemens Healthcare Diagnostics. “We are the only manufacturer to offer laboratories both tests FDA approved for use on an automated instrument, which helps our customers advance the delivery of these tests to physicians. Customers will truly benefit from this next-generation molecular technology and have greater throughput and less hands-on time—maximizing productivity to meet the evolving needs of the molecular laboratory.”

The VERSANT 440 Molecular System uses branched DNA (bDNA) technology that helps to reduce the risk of cross-contamination. The instrument is designed for flexible walk-away automation and has a small footprint so it fits easily in the laboratory. It streamlines workflow by integrating bar code data entry, automated reagent processing, signal amplification detection, and a Laboratory Information System (LIS) interface for transfer of patient work lists and results.

The VERSANT 440 was CE marked in 2006 and has been successfully launched throughout Europe, Africa, and parts of Asia and the Americas.