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BD wins FDA approval for MAX CT/GC/TV assay

MDBR Staff Writer Published 15 September 2016

Becton, Dickinson and Company (BD) has secured approval from the US Food and Drug Administration (FDA) for its MAX CT/GC/TV assay.

The assay has been approved to detect Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV) from a single specimen in one test.

According to the company, CT, GC and TV are the most prevalent sexually transmitted infections (STIs).

BD MAX System provides results through automated nucleic acid extraction, real-time PCR amplification and detection.

Specimen collection options provided include urine specimens, self-collected vaginal swabs and clinician-collected endocervical swabs.

Later, the samples will be loaded onto the BD MAX system. Results will be provided within three hours.

The US Centers for Disease Control and Prevention (CDC) has recommended highly sensitive and specific tests such as nucleic acid amplification test (NAAT) technology for Trichomonas detection.

BD molecular diagnostics and women's health general manager and vice president Doug White said: "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.

"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."

Earlier this month, the company also submitted pre-market approval (PMA) application to the FDA for the Onclarity human papillomavirus (HPV) assay.

The PMA has been submitted for use of the BD Onclarity HPV assay with SurePath specimens to detect 14 high-risk HPV types to determine the need for referral to colposcopy for women 21 and older with abnormal (ASC-US) Pap test results.


Image: BD has secured FDA approval for MAX CT/GC/TV assay. Photo: courtesy of Suwit Ritjaroon / FreeDigitalPhotos.net.