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Dx Focus: BD Diagnostics ProbeTec Trichomonas Assay; Cepheid Xpert MTB/RIF

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Becton Dickinson's BD Diagnostics segment said this week that the US Food and Drug Administration has cleared the BD ProbeTec Trichomonas vaginalis Qx Amplified DNA Assay on the BD Viper System with XTR technology.

The assay qualitatively detects T. vaginalis DNA in endocervical and vaginal samples as well as neat urine specimens to aid in the diagnosis of trichomoniasis. The test was previously CE marked for in vitro diagnostic use.

Trichomoniasis is the most common curable sexually transmitted infection. Worldwide, more than 180 million cases are estimated to occur annually.

"The global prevalence of trichomoniasis is on the rise and there are more asymptomatic cases than previously thought," Chris Demiris, worldwide group marketing manager for diagnostic systems, women's health and cancer at BD Diagnostics, said in a statement. "The availability of an automated platform is especially important as clinical and public health communities embrace the need for a test that provides timely and accurate diagnosis of trichomoniasis when screening high-risk populations."

The BD Viper system automates DNA extraction, amplification, and detection. Compared to wet mount microscopy and culture, the ProbeTec assay reduces human intervention and associated variables and improves speed to results. The BD Viper System allows laboratories to test samples in panel mode for T. vaginalis, Chlamydia trachomatis and Neisseria gonorrhoeae; or in batch mode for CT/NG, trichomonas, and herpes.


Cepheid said this week that the US Food and Drug Administration has categorized Cepheid's Xpert MTB/RIF test as moderate complexity under CLIA guidelines.

Xpert MTB/RIF runs on Cepheid's GeneXpert system and is designed for the rapid molecular detection of Mycobacterium tuberculosis complex DNA and rifampin-resistance associated mutations of the rpoB gene. The assay provides results in two hours, compared to up to three months with traditional methods of detecting drug-resistant TB, according to Cepheid.

The FDA granted de novo 510(k) clearance to Xpert MTB/RIF last month. Cepheid has been selling the assay outside the US for nearly two years under its high-burden developing country program.

The assay becomes the first and only molecular TB test to be categorized as CLIA moderately complex.

"The dramatic impact of Xpert MTB/RIF on identifying TB positive patients and optimizing their drug therapy has been well documented outside of the US," Cepheid CEO John Bishop said in a statement. "Now, US clinicians can leverage those same transformative results not only for the detection of TB, but also for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy."

The Scan

Booster for At-Risk

The New York Times reports that the US Food and Drug Administration has authorized a third dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for people over 65 or at increased risk.

Preprints OK to Mention Again

Nature News reports the Australian Research Council has changed its new policy and now allows preprints to be cited in grant applications.

Hundreds of Millions More to Share

The US plans to purchase and donate 500 million additional SARS-CoV-2 vaccine doses, according to the Washington Post.

Nature Papers Examine Molecular Program Differences Influencing Neural Cells, Population History of Polynesia

In Nature this week: changes in molecular program during embryonic development leads to different neural cell types, and more.