Cepheid Xpert GBS test categorized as 'moderate complexity'

By Elaine Rigoli

Tampa, Fla., Aug. 22 - Cepheid said Tuesday that its recently cleared Xpert GBS test for Group B streptococcus has now been categorized by the Food and Drug Administration as "moderate complexity" under the Clinical Laboratory Improvement Amendments.

The company said its Xpert GBS assay is the first amplified molecular diagnostic test using real time polymerase chain reaction (PCR) to receive the moderate complexity categorization, which will allow the test to be performed by institutions registered for moderate complexity in addition to institutions registered for high complexity, accounting for more than 34,000 laboratories nationwide.

"Until now, most clinical molecular diagnostic testing has been limited to institutions that could build and support specialized, sophisticated laboratories and specially trained lab personnel. Although PCR-based technology has been shown to generate relatively fast and highly accurate results, it has remained inaccessible to many of the clinical settings that need it most. With the moderate complexity categorization, the Xpert GBS test can be easily performed on-site and on-demand by clinical personnel 24 hours a day, seven days a week," chief executive officer John Bishop said in a news release.

A moderately complex molecular test is an asset to delivery-room personnel, officials noted. According to the U.S. Centers for Disease Control, Group B streptococcus bacterium is the most common cause of life-threatening infections in newborns and is the leading infectious cause of neonatal morbidity and mortality.

Cepheid, based in Sunnyvale, Calif., is a molecular diagnostics company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.