FDA Clears BD’s BD MAX CT/GC/TV Assay on the BD MAX System

BD (Becton, Dickinson and Company) today announced that it obtained U.S. Food and Drug Administration (FDA) clearance for the BD MAX CT/GC/TV assay, which is also CE marked in Europe, Canada, and Australia and launched there in spring of 2015.
 
The BD MAX CT/GC/TV assay provides health care providers the ability to detect for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV) from a single specimen in just one test.
 
CT, GC and TV are among the most prevalent sexually transmitted infections (STIs).  Reports from the U.S. Centers for Disease Control and Prevention (CDC) estimate 2.86 million new chlamydial infections and 820,000 gonorrheal infections each year.^1,2 Trichomoniasis, a much neglected STI until recently, is the most prevalent non-viral sexually transmitted infection in the United States, affecting an estimated 3.7 million people.³ Although most of these infections are asymptomatic, they can have serious consequences if left unaddressed, such as pelvic inflammatory disease, ectopic pregnancies, infertility, pre-term or low birth-weight babies and increased risk of STI transmission or infection (including HIV) in males and females. Trichomonas can be difficult to diagnose with manual methods, and despite its high prevalence in many populations, awareness remains low. The CDC 2015 guidance recommends the use of highly sensitive and specific tests, such as nucleic acid amplification test (NAAT) technology, as the recommended test for Trichomonas detection.
 
The BD MAX CT/GC/TV assay allows health care providers to detect these common and addressable STIs from a single specimen in just one test. Specimen collection options are flexible, allowing for urine specimens, self-collected vaginal swabs and clinician-collected endocervical swabs. Once samples are loaded onto the BD MAX System, results will be ready in less than three hours, and all reagents are ready-to-use and can be stored at room temperature.
 
“The FDA clearance and launch of the BD MAX CT/GC/TV assay in the U.S. brings a “one-test” approach to detect for three sexually transmitted infections,” said Doug White, vice president and general manager of Molecular Diagnostics and Women’s Health for BD. “This represents just one of several expansions to the BD MAX portfolio in 2016, as BD continues to expand the capabilities of the platform with a focus on comprehensive syndromic solutions with an emphasis on improving clinical outcomes and laboratory efficiency.”
 
References
¹Chlamydia – CDC Fact Sheet (Detailed), Sept. 24, 2015  http://www.cdc.gov/std/chlamydia/stdfact-chlamydia-detailed.htm#_ENREF_4  as of Oct.12, 2015
²Gonorrhea – CDC Fact Sheet (Detailed Version)
http://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm as of Oct. 12, 2015 
³CDC Morbidity and Mortality Weekly Report, June 5, 2015, pg. 72. http://www.cdc.gov/mmwr/pdf/rr/rr6403.pdf