NEW YORK (GenomeWeb News) – Cepheid today said that the US Food and Drug Administration has categorized the firm's Xpert CT/NG test as moderate complexity under the Clinical Laboratory Improvement Amendments.
Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae. The test runs on Cepheid's GeneXpert molecular testing system, and is the first molecular CT/NG test to be categorized as moderately complex and the twelfth Cepheid test to be categorized as such, the Sunnyvale, Calif.-based firm said.
"Now accessible to more than 20,000 moderately complex US labs and 7,000 high-complexity US labs, Xpert CT/NG becomes an important new weapon in reducing STD rates as clinicians can test, consult with, and treat their patients on a more timely basis," Cepheid CEO John Bishop said in a statement.
Cepheid said it will begin shipping the test this month.