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Aptima® Sexual and Vaginal Health Solutions Test

Rely on excellent sensitivity and specificity for your sexual and vaginal health testing needs.

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    Overview

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    Overview

    The most comprehensive sexual and vaginal health molecular menu.

    Hologic offers the most comprehensive sexual and vaginal health portfolio that allows you to automate molecular testing workflows while instilling confidence in your clinical results. 

    Multitest Diagram

    One Sample, Multiple Results

    With innovative nucleic acid amplification test (NAAT) and a single collection device, the Aptima® Multitest Swab simplifies testing by helping to detect up to 7 infections and disease states from just 1 vaginal swab.1-5

    Expert Partner

    Through continuous clinical research and trusted testing solutions, Hologic supports our partners in the fight against sexually transmitted infections (STIs) and accurate detection of vaginitis.

    Proven Performance

    Our sexual and vaginal health portfolio leverages best-in-class technology to provide timely and reliable results to patients.
     

    Streamlined Workflow

    The Aptima sexual and vaginal health portfolio can run alongside multiple disease areas on our fully automated Panther® Scalable Solutions.

    Evolve Your Offerings with Aptima Assays

    7 infections and disease states

    can be detected with the Aptima sexual and vaginal health portfolio to support your testing needs. 

    35 years of experience

    in sexual and vaginal health molecular testing and helping stop the spread of disease.

    A Comprehensive, Flexible Menu

    By expanding access to timely and accurate results, Hologic empowers patients to protect their sexual and reproductive health.

    Aptima Combo 2® assay (for chlamydia / gonorrhea)

    Detects chlamydia and gonorrhea from a single sample. By using this highly specific and sensitive test, laboratories can improve workflow while allowing healthcare professionals to identify and treat patients with these often-asymptomatic infections to prevent long-term health consequences.1

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    Aptima® Trichomonas vaginalis assay

    The first NAAT cleared by the FDA to test patients with or without symptoms for trichomoniasis. This test delivers up to 100% sensitivity and detects infections missed by traditional methods to improve overall patient care.5

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    Aptima® Mycoplasma genitalium assay

    When identifying Mycoplasma genitalium, the test you choose matters. A highly sensitive rRNA test is needed for an accurate diagnosis, and NAAT is the most effective way to identify this STI. Hologic developed the first FDA-cleared sample-to-result test to detect this highly prevalent STI.2

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    Aptima® Herpes Simplex Viruses 1 & 2 assay

    Provides specific knowledge required for healthcare professionals to better manage treatment for patients and provide targeted counseling based on the HSV infection type.6

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    Aptima® BV assay

    Demonstrates excellent sensitivity and specificity, due to its proprietary quantitative algorithm and assay design, targeting Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus species. A simple qualitative BV positive or negative result is returned.4

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    Aptima® CV/TV assay

    Detects and differentiates microorganisms associated with vulvovaginal candidiasis (candida vaginitis or "CV”), commonly known as a yeast infection and trichomoniasis or “TV,” sometimes referred to as “trich.”3

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    Aptima® Neisseria gonorrhoeae assay

    A standalone NAAT for the detection of rRNA from Neisseria gonorrhoeae to aid in the diagnosis of gonococcal urogenital disease using the Panther® System. Provides excellent performance and an alternative option for detection of gonorrhea.

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    Aptima® Chlamydia trachomatis assay

    A standalone NAAT for the detection of rRNA from Chlamydia trachomatis to aid in the diagnosis of chlamydial urogenital disease using the Panther® System. Provides excellent performance and an alternative option for detection of chlamydia.

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    The Significance of Diagnostic Testing in Women’s Health: Mycoplasma genitalium

    Dr. Kyle Bukowski*, Chief Medical Officer for Planned Parenthood of Maryland, discusses real-world data reflective of current practices in the U.S. for Mycoplasma genitalium.

    The Latest News on Aptima Sexual and Vaginal Health

    Expanded Sample Collection Methods Offer Greater Flexibility and Access to Reliable Trichomoniasis Testing

    NAAT Testing for M. Gen Allows for Accurate Diagnosis, More Effective Treatment Decisions, and Long-Term Patient Health

    Adopting the Latest Screening Approaches Can Help Reverse the Growing Rate of Sexually Transmitted Infections

    Increasing Certainty in Sexual & Vaginal Health

    The Aptima sexual and vaginal health portfolio represents a comprehensive menu to champion women’s health worldwide. By supporting sexual health testing with innovative technology and a fully automated, sample-to-result platform, we are helping advance early detection and treatment.

    Hologic is committed to protecting sexual and reproductive health by preventing the spread of STIs and vaginitis. We are continuously investing in R&D efforts designed to deliver new products to help healthcare providers and laboratories provide better patient care, now and in the future.  

    Timeline

    First FDA-Cleared STI Molecular Test

    FDA clears the first molecular diagnostic test kit for an STI: the Aptima Combo 2 assay for chlamydia and gonorrhea (CT/NG).

    Aptima HPV assay

    Aptima HPV assay is the first FDA-cleared test for human papillomavirus (HPV) mRNA, and the test detects mRNA in 14 high risk HPV types associated with cervical cancer.

    Panther System Introduced

     

    FDA clears the Panther system, an automated, integrated molecular platform, for use with the Aptima Combo 2 assay. Today, this scalable instrument supports labs with a robust menu of 20+ assays. 

    Hologic receives FDA clearance for the Aptima HPV 16/18/45 Genotype assay on its Tigris system. This assay was the first test FDA-cleared for genotyping HPV types 16, 18 and/or 45. 

     

    Aptima Trichomonas vaginalis assay

    Hologic introduces the FDA-cleared Aptima Trichomonas vaginalis assay for the identification of Trichomonas vaginalis (TV), the most common curable STI with a prevalence higher than CT and NG combined.7

    Aptima HSV 1 & 2 assay

    The Aptima Herpes Simplex Virus (HSV) 1 & 2 molecular assay receives FDA clearance to qualitatively detect, and differentiate between, HSV-1 and HSV-2.

    Aptima Zika Virus assay

    The FDA issues an Emergency Use Authorization (EUA) to authorize the use of the Aptima Zika Virus assay for the in vitro qualitative detection of Zika virus.8

    Aptima M. gen assay

    FDA clears the Aptima Mycoplasma genitalium assay, the first FDA-cleared test to detect this under-recognized but highly prevalent STI. 

    Aptima BV and CV/TV assays

    The FDA granted clearance for the Aptima BV and Aptima CV/TV assays, which provide an accurate and objective method for diagnosing vaginitis.

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    *Speaker and consultant for Hologic, Inc.
      References
      *The Aptima Zika Virus assay: This test has not been FDA cleared or approved; This test has been authorized by FDA under an EUA for use by authorized laboratories; This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
      † Speaker and consultant for Hologic, Inc.
      References: 1. Aptima Combo 2 Assay [package insert]. AW-20535, San Diego,CA; Hologic, Inc., 2022. 2. Aptima Mycoplasma genitalium assay [package insert]. AW-17946, San Diego, CA; Hologic, Inc., 2019. 3. Aptima CV/TV assay [package insert]. AW-18812, San Diego, CA;Hologic, Inc., 2021 4. Aptima BV assay [package insert]. AW-18811, San Diego, CA; Hologic, Inc., 2020. 5. Aptima Trichomonas vaginalis Assay [package insert]. 503684, San Diego, CA; Hologic, Inc., 2020. 6. Aptima HSV 1 & 2 assay [package insert]. AW-15346-001, San Diego, CA; Hologic, Inc., 2019. 7. CDC. Incidence, Prevalence, and Cost of Sexually Transmitted Infection in the United States. Last reviewed: March 16, 2022. Accessed July 7, 2022. https://www.cdc.gov/nchhstp/newsroom/fact-sheets/std/STI-Incidence-Prevalence-Cost-Factsheet.html [cdc.gov]. 8. Aptima Zika virus assay [package insert]. AW-15406, San Diego, CA; Hologic, Inc., 2018.
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