Cepheid, Sunnyvale, Calif, has received premarket notification (510(k)) clearance from FDA to market Xpert TV, a qualitative in vitro diagnostic for accurate and reproducible identification of trichomoniasis in symptomatic and asymptomatic female patients, using urine, endocervical swab, or vaginal swabs collected by the patient in a clinical setting.
Xpert TV is the 18th test available to run on Cepheid’s GeneXpert system in the United States. According to the company, the test is an important addition to its Xpert women’s health portfolio, which includes Xpert CT/NG for Chlamydia trachomatis and Neisseria gonorrhoeae, and Xpert Group B Strep. The company’s Xpert HPV test for human papillomavirus is available outside the United States.
The most common nonviral sexually transmitted infection, trichomoniasis is caused by the protozoan parasite Trichomonas vaginalis, and affects an estimated 170 million people globally every year, including an estimated 3.7 million people annually in the United States.1 Of those infected, up to 85% of individuals have minimal to no symptoms. Infection is associated with a two- to threefold increased risk of HIV acquisition, preterm birth, and other adverse outcomes among pregnant women.2
“The commercial launch of Xpert TV is particularly timely given CDC’s recently revised recommendation to use highly sensitive and specific nucleic acid amplification testing for the detection of Trichomonas vaginalis in both symptomatic and asymptomatic patients,” says David Persing, MD, PhD, chief medical and technology officer at Cepheid. “Xpert TV provides reference laboratory levels of performance in an on-demand, easy-to-use format. For the first time, clinicians can offer same-day consultation and treatment for TV, with results available in about an hour, in most cases.”
Xpert TV will begin shipping in the United States in early November. For more information, visit Cepheid.
- Gaydos C, Ginocchio CC, Chapin KC, Smith J, Aslanzadeh J. Risk factors associated with Trichomonas vaginalis infection as measured with a nucleic acid amplification test in women in the United States [presentation abstract]. Minneapolis: Centers for Disease Control and Prevention, National STD Prevention Conference, March 12–15, 2012. Available at: www.researchgate.net/publication/267879978_Risk_factors_associated_with_trichomonas_vaginalis_infection_as_measured_with_a_nucleic_acid_amplification_test_in_women_in_the_United_States. Accessed October 26, 2015.
- Workowski KA, Berman G. Sexually transmitted diseases treatment guidelines, 2010 [online]. Atlanta: US Centers for Disease Control and Prevention, 2010. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5912a1.htm. Accessed October 26, 2015.