FDA Approves Roche's Blood Screening Assay for Simultaneous Detection and Identification of Three Major Viral Targets

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved the cobas® TaqScreen MPX Test, v2.0 for use in the detection and identification of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma.

This latest version of the cobas TaqScreen MPX Test provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay. The combination of viral target detection and identification steps on a fully automated system offers workflow advantages to blood and plasma testing centers by eliminating the need for consecutive rounds of testing, and facilitating earlier donor counseling in the event of a positive result.

“Since 1998, Roche has developed assays and systems designed to protect the blood and plasma supply on a global scale,” said Roland Diggelmann, COO of Roche Diagnostics. “By continually developing these innovative products we are striving for the highest level of safety for patients and efficiency for blood and plasma centers. This latest approval supports that commitment.”

Along with CE Mark and recent approvals in Canada, Brazil, China, and India, FDA approval of the cobas TaqScreen MPX Test, v2.0 supports safety standards of blood and plasma centers worldwide. By utilizing real-time, multi-dye PCR technology, individual specimens are simultaneously detected and discriminated for HIV, HCV and HBV, reducing the sample volume required and the turnaround time for donor testing.

About the cobas TaqScreen MPX Test, v2.0

The cobas® TaqScreen MPX Test, v2.0 is a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA in human plasma. This test is intended for use in the screening donations of human whole blood and blood components in pools of 6 samples, and source plasma donations in pools of up to 96 samples.

The test runs on the fully automated cobas s 201 system, which is designed to increase processing efficiency in a unique modular design with ready-to-use reagents. The cobas s 201 system allows signal detection in four separate channels, facilitating simultaneous monitoring of three viral targets (HIV, HCV and HBV) plus a full-process internal control. In addition to HIV, HCV and HBV, the menu of the cobas s 201 system includes tests for West Nile virus, parvovirus B19 (B19V) and hepatitis A virus (HAV). All Roche blood screening tests are based on Nucleic Acid Amplification Technology (NAT) which offers earlier detection of viruses than traditional serology testing. The cobas s 201 system offers a comprehensive NAT test menu available on a single automated platform.