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Becton Dickinson Strengthens Position in Women's Health, STI Testing With New FDA Approvals

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NEW YORK (GenomeWeb) – With two newly approved panels, Becton Dickinson has expanded its profile in the sexually transmitted infection and women's health testing markets. The tests are part of a small, focused panel approach which the firm believes will resonate with physicians and labs.

BD received approval from the US Food and Drug Administration this week for a test to detect common causes of vaginitis. The BD Max Vaginal Panel, which was also CE marked earlier this year, detects pathogens responsible for bacterial vaginosis, candidiasis, and trichomoniasis.

The firm also received clearance in September for a triplex STI test to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis from a single specimen. That test had been CE marked in 2015. Results of the firm's clinical trial of the BD Max CT/GC/TV assay were published last week in the Journal of Clinical Microbiology.

Women's health and STI testing is not new to BD, and the firm already has multiple tests and systems on the market, Doug White, vice president and general manager of molecular diagnostics and women’s health for BD, told GenomeWeb in an email.

"Our focus is on providing comprehensive, fully automated molecular panels for the mid- to low-volume acute clinic and hospital labs [via the] BD Max, as well as high-volume core and reference labs with the Viper XTR and LT systems," White said. The firm also offers a probe-based visual read system for vaginitis on the BD Affirm system.

Meanwhile, BD's approach to panels is somewhat unique in the market. The firm is deliberately designing small, focused molecular testing panels, rather than larger syndromic molecular panels that detect many different viruses and bacteria.

For the firm's enteric solutions, for example, BD's worldwide market segment director for molecular told GenomeWeb last year that the strategy was to offer separate panels for bacteria, viruses, and parasites. In this way, the firm hopes to tap into labs' desires to improve test utilization and avoid overuse.

White noted that the CT/GC/TV test was developed with the three specific targets it has because, "these infections often share similar clinical signs and symptoms, and high-risk sexual behaviors increase the risk of transmission or acquisition of all three."

This trio of infections also represents the three most common, curable, non-viral STIs, White said, noting that testing all three at once can improve the coverage of diagnosis as well as the cost and efficiency of testing.

Trichomonas is not frequently tested for, White pointed out, even though it is much more prevalent than gonorrhea and is more commonly seen as a co-infection with chlamydia than is gonorrhea. Also, about 70 percent of the 3.7 million people infected with the protozoan parasite have no symptoms, according to the US Centers for Disease Control and Prevention.

The CDC recently recommended nucleic acid testing for trichomonas, specifically mentioning BD's ProbeTec assay for the parasite in its guidelines. Nucleic acid testing has also been emphasized in the most recent guidelines from the US Preventive Services Task Force for diagnosis chlamydia and gonorrhea.

Last week's JCM evaluation described the results of the clinical trials for the CT/GC/TV test. There were 1,143 female patients tested with the entire panel, and another 847 tested for just the gonorrhea and chlamydia components. These tests used endocervical and vaginal swabs as well as urine specimens. And about 800 urine samples from males were also tested for gonorrhea and chlamydia.

Comparator assays included the BD CTQ/GCQ test for gonorrhea and chlamydia, the Hologic Aptima Combo 2 for CT/NG and Aptima Trichomonas vaginalis assay tests, trichomonas microscopy, and culture.

According to the study, sensitivities for the chlamydia target were 99 percent, 96 percent, 92 percent, and 96 percent for vaginal swabs, endocervical swabs, female urine, and male urine, respectively, while the gonorrhea target's sensitivity was approximately 96 percent for all female samples and 99 percent for male urine.

The trichomonas target showed a sensitivity of 96 percent for vaginal swabs, and around 93 percent for endocervical swabs and female urine.

The researchers — in labs at the University of Alabama at Birmingham School of Medicine, Indiana University School of Medicine, Eskanazi Health Services in Indianapolis, and Louisiana State University Health Sciences Center — also found a specificity of greater than about 99 percent for all targets and sample types.

White noted that the trial showed that the test's performance using self-collected vaginal swabs — which are recommended by CDC because they are convenient and tend to be preferred by patients over endocervical swabs — is "equivalent with other assays on the market."

Based on the clinical performance, and with the benefit of versatility from the BD Max platform, White said the firm is confident it is offering "a solution for medium- to low-volume laboratories that will enable expansion and decentralization of testing, while increasing the opportunity for routine screening of these three common STIs."

For the vaginosis panel, the assay design was also based on capturing the three main causes of vaginal infection symptoms, a list which also happens to include trichomonas.

In this case, accurate diagnosis is particularly important because treatment differs depending on whether a patient has bacterial vaginosis, vulvo-vaginal candidiasis, or trichomoniasis, White said.

The panel also uses slightly different approaches for each target. "The bacterial vaginosis portion of the assay is based on analysis of the vaginal microbiome [and] the algorithm developed provides a positive or negative BV result based on the presence, absence, and relative load of the BV markers," White said. For candidiasis infection, the test detects the major species of Candida yeast and is designed to identify species that are resistant to antifungal therapy, he said.

White said that clinical data has suggested the vaginal panel will be at least 25 percent more sensitive and 10 percent more specific than currently used testing, and, based on this performance, no additional or confirmatory tests are needed to diagnose vaginal infection.

Overall, the new STI and women’s health panels panels will complement, rather than compete with, BD's current portfolio of systems and assays, White asserted, with the BD Max platform specifically addressing the needs of clinical laboratories by providing fully automated, random access, cartridge-based panels.

The firm also has a pipeline of assays being developed on the BD Max, including enteric, hospital-acquired infection, respiratory, and additional STI panels, White said.

"Additionally, our women's health portfolio includes the SurePath liquid-based cytology solution that includes automated processing of slides, and we recently submitted a [pre-market approval] to the FDA for our Onclarity HPV assay that is currently CE marked and available in Europe and other major markets outside of the US," he said.

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