NEW YORK (GenomeWeb News) – The US Food and Drug Administration has said CLIA labs can use Cepheid’s Xpert Group B Streptococcus test, Cepheid said today.
Last month the agency cleared the test as an in vitro diagnostic. The recent move, which categorizes the Xpert test as "moderate complexity," means the test can be used by 27,000 additional labs.
Cepheid said the Xpert assay is the first amplified molecular diagnostic using real-time PCR to receive the moderate complexity CLIA categorization.
The test is designed to detect Group B Strep DNA in vaginal and rectal swabs in the point-of-care setting.