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Becton Dickinson Triplex STD Test Clears FDA Review

NEW YORK (GenomeWeb) – A triplex test from Becton Dickinson to detect chlyamydia, gonorrhea, and trichomonas has been cleared by the US Food and Drug Administration, the company announced today.

The BD MAX CT/GC/TV assay runs on the firm's BD MAX automated PCR system and detects Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis from a single specimen. The test has been cleared for urine specimens, self-collected vaginal swabs, and clinician-collected endocervical swabs. After samples are loaded onto the BD MAX System, results are ready in three hours.

"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," Doug White, vice president and general manager of molecular diagnostics and women's health, said in a statement.

These three sexually transmitted infections are among the most prevalent in the US, with the Centers for Disease Control and Prevention estimating 2.86 million new chlamydial and 820,000 gonorrheal infections per year, and 3.7 million people affected by Trichomoniasis. The CDC has also recommended that nucleic acid amplification tests be used for routine trichomonas screening for high-risk populations.

Becton Dickinson is expanding its portfolio of reproductive and sexually transmitted infections solutions. The firm filed for FDA approval of an HPV test last week, and its vaginal pathogen panel was CE marked earlier this year. The BD Max CT/GC/TV assay was CE marked in 2015.