The US Food & Drug Administration (FDA) has categorized Cepheid's Xpert CT/NG test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).
The test runs on Cepheid's GeneXpert Systems and is the first and only molecular CT/NG test to be categorized as Moderately Complex. The Moderately Complex categorization will now allow the accuracy benefits of molecular diagnostics to be realized over a broader testing universe.
"In a recent study of 23 developed countries by the Institute of Medicine and the National Research Council, the US was found to have the highest rates of Sexually Transmitted Diseases among youths," said John Bishop, chief executive officer, Cepheid. He further added, "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."
"The classification of Xpert CT/NG by the FDA as 'Moderate Complexity' is a breakthrough for sexual health and STD prevention. The large number of Moderate Complexity point-of-care laboratories that exist in US hospitals and clinics can now offer rapid, highly accurate and private same-day STD testing," said Jeffrey D Klausner, MD, MPH, Professor of Medicine, UCLA-David Geffen School of Medicine. "Public health officials need to work with providers to increase the availability of those tests. Faster STD detection and treatment could go a long way in stemming the continued epidemic of STDs in the United States."
Gonorrhoea and Chlamydia are sexually transmitted diseases (STDs). Both are easily treated when detected and managed quickly. Chlamydia remains the most common sexually transmitted bacterial infection in the United States. While the CDC recommends annual testing for all sexually active women aged 25 and under, their most recent nationally representative estimate among this population found that only 38 per cent of sexually active women were tested for chlamydia during the previous year.
Gonorrhoea is the second most commonly reported bacterial infectious disease in the country. The CDC estimates that more than 700,000 Americans become infected with gonorrhea every year, yet fewer than half of these infections are diagnosed and reported to the CDC. Current testing protocols for Neisseria gonorrhoeae are often problematic due to cross-reactivity with other organisms, often requiring an additional confirmatory test. These delays and coordination issues can significantly hamper communication and consultation, leaving both patients and their partners uninformed and untreated.
The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories: waived tests, tests of moderate complexity and tests of high complexity.
Cepheid was the first company to receive a 'Moderate Complexity' categorization for a nucleic acid test and Xpert CT/NG is the 12th Cepheid test to be categorized as such. Xpert CT/NG will begin shipping this month.
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands found in clinical environments.
Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.