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Cepheid Receives FDA Clearance for Extragenital Claims for Xpert® CT/NG Test
SUNNYVALE, Calif., May 29, 2019 /PRNewswire/ -- Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for testing throat and rectal specimens with its Xpert® CT/NG test. The test provides fast and accurate molecular detection of chlamydia and gonorrhea, making same-day consultation and treatment possible.
Xpert CT/NG test is an automated in vitro diagnostic test for qualitative detection and differentiation of DNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae. In addition to the new extragenital specimens, Xpert CT/NG is indicated for use with urine, vaginal, and endocervical specimens from symptomatic and asymptomatic patients.
"Xpert CT/NG is the most sophisticated test in its class, yet it can be performed on-demand by virtually any laboratory to maximize the medical impact of the results. Adding throat and rectal sample types addresses a critical unmet need allowing for more complete patient screening," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Considering the increasing rates of chlamydial and gonorrheal infection, this is particularly important for public health screening programs, to capture patients who previously would have gone undiagnosed if only genital specimens were tested.1,2 It is not uncommon for patients to have an infection only in their throat or rectum, which may be asymptomatic. Same day consultation and treatment is critical for patient management so patients are not lost to follow up."
Detection of patients with extragenital gonorrheal and chlamydial infections is critical for optimal treatment of disease and can prevent development of antibiotic resistance in strains due to inadequate treatment regimens that do not cover extragenital sites.3,4 This is particularly important for men who have sex with men, where disease may be limited to the pharynx or rectum. Such infections will go undetected if only genital sites are tested.5 Extragenital disease has also been reported in women.6
The clinical study used to validate the new claims was led by Drs. Jeffrey Klausner of University of California Los Angeles and Sarah Doernberg of University of California, San Francisco, and coordinated by the Antibacterial Resistance Leadership Group (ARLG), which is funded and supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1AI104681.*
"Over the last decade, cases of chlamydia and gonorrhea have continued to increase sharply both in the Unites States and abroad necessitating better diagnostics and treatment regimens," said Dr. Jeffrey Klausner, professor of medicine and public health at the University of California, Los Angeles, and lead researcher on the study. "Screening for both genital and extragenital disease with fast turn-around times is critical for optimizing therapy for both male and female populations to reduce the spread of infection."
The Xpert CT/NG test is performed on the Cepheid GeneXpert® Systems. The test's capability to detect DNA from organisms in both genital and extragenital specimens allows for improved screening and detection in patients to ensure infections can be treated in the same day.
For more information on Cepheid's GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheid.com.
For more information on Antibacterial Resistance Leadership Group, visit https://arlg.org/.
Based in Sunnyvale, Calif., 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. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.
*The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
- CDC. Sexually Transmitted Disease Surveillance 2017. Accessed Mar 2019. https://www.cdc.gov/std/stats17/infographic.htm
- Patton ME, et al. Extragenital gonorrhea and chlamydia testing and infection among men who have sex with men – STD Surveillance Network, United States, 2010-2012. Clin Infect Dis. 2014 Jun;58(11):1564-70.
- Deguchi T, Yasuda M, Ito S. 2012. Management of pharyngeal gonorrhea is crucial to prevent the emergence and spread of antibiotic-resistant Neisseria gonorrhoeae. Antimicrob Agents Chemother. 56: 4039-4040.
- Dukers-Muijrers NHTM, Schachter J, van Liere GAFS, et al. 2015. What is needed to guide testing for anorectal and pharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae in women and men? Evidence and opinion. BMC Infectious Diseases. 15;533:1-13.
- Tao G, Hoover KW, Nye MB, et. al. 2016. Rectal infection with Neisseria gonorrhoeae and Chlamydia trachomatis in men in the United States. Clin Infect Dis. 63(10):1325-1331.
- Cosentino LA, Danby CS, Rabe LK, et.al. 2017. Use of nucleic acid amplification testing for diagnosis of extragenital sexually transmitted infections. J Clin Microbiol. 55(9):2801-2807.
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