FAQ

Answers to some frequently asked questions.

Sexual Health Test

What is the Visby Medical Sexual Health Click Test?

The Visby Medical Sexual Health Click Test is a single-use, fully-integrated, rapid, automated polymerase chain reaction (PCR) in-vitro diagnostic test for the qualitative detection and differentiation of DNA from Chlamydia, Gonorrhea, Trichomoniasis infections.

What type of test is the Visby Medical Sexual Health Click Test?

The Visby Medical Sexual Health Click Test is a single-use (disposable), fully-integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test intended for use in point-of-care or clinical laboratory settings for the rapid detection and differentiation of DNA from Chlamydia trachomatis(CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis(TV) in self-collected female vaginal swab specimens collected in Visby Medical Collection Media in a health care setting. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with CT, NG, and TV.

Who can use the Visby Medical Sexual Health Click Test?

The Visby Medical Sexual Health Click Test is intended for use with vaginal samples from women, aged 14 years of age or older.

What is the clinical performance of the Visby Medical Sexual Health Click Test?

The details of the clinical performance can be found in the Instructions for Use. Results of the clinical study for the test were published by the Lancet Infectious Diseases

When will the Sexual Health Click Test be available?

The Visby Medical Sexual Health Click Test will begin shipping in the late summer of 2021.

Will I need a prescription to use this test?

Yes, the Visby Sexual Health Click Test will only be available in CLIA-waived point-of-care settings with a prescription, such as a clinician’s office.

What does the FDA clearance mean for Visby and for the use of the Visby Medical Sexual Health Click Test?

  • There remains a need for diagnosis prior to treatment – treatment for STIs is, currently, usually conducted without a timely diagnostic result present, resulting in over or under treatment, the need for further clinic visits, additional treatments, and elongation of the infection itself.
    • Typically, on-site testing takes 24-48 hours and send-out testing takes 6-13 days, forcing women to wait for a diagnosis, clinicians to prescribe blindly, relying mainly on empirical experience without data, causing stress and anxiety for both patients and clinicians.
    • Visby Medical delivers innovation that makes PCR fast, accessible, affordable, and simple: Immediacy to test within ~30 minutes and helps to ensure appropriate treatment during a single patient visit, and freedom from instrument commitment and  maintenance.
    • The clearance by the FDA for the Visby Medical Sexual Health Click Test validates Visby Medical’s PCR technology as a comparable option for clinicians to test and help diagnose infectious diseases, and provides a tool to enable clinicians to test first and appropriately treat thereafter.

Why the focus on women’s health specifically?

  • Women are disproportionately impacted by these infections – they are more likely to experience symptoms, have serious long-term health issues if left untreated, and the infections can cause future fertility and maternity impairment.
  • According to the CDC: in 2018, new infections totaled nearly $16 billion in direct lifetime medical costs, and women face a disproportionate burden in terms of severe health outcomes and medical costs2.
  • The CDC reported an estimated 68 Million active STIs in 2018, and 26 Million new STIs; which included1
    • 6.9 million new in trichomoniasis infections
    • 4 million new chlamydia infections
    • 1.6 million new gonorrhea infections
  1. Kreisel, Kristen M. PhD∗; Spicknall, Ian H. PhD∗; Gargano, Julia W. PhD†; Lewis, Felicia M.T. MD∗,‡; Lewis, Rayleen M. MPH†; Markowitz, Lauri E. MD†; Roberts, Henry PhD§; Johnson, Anna Satcher MPH¶; Song, Ruiguang PhD¶; St. Cyr, Sancta B. MD∗; Weston, Emily J. MPH∗; Torrone, Elizabeth A. PhD∗; Weinstock, Hillard S. MD∗ Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2018, Sexually Transmitted Diseases: April 2021 – Volume 48 – Issue 4 – p 208-214 doi: 10.1097/OLQ.0000000000001355
  2. CDC estimates 1 in 5 people in the U.S. have a sexually transmitted infection | CDC Online Newsroom | CDC

Why does the Visby Medical Sexual Health Test include these three infections?

  • As a diagnostic company, we understand that chlamydia and gonorrhea are currently two of the most widely spread STIs, making their quick diagnosis and treatment of high importance.
    • Furthermore, STIs are frequently asymptomatic, with nearly 50% of gonorrhea cases and 80% of chlamydia cases being asymptomatic in women.
  • Currently, there is no reporting requirement for trichomoniasis by public health authorities, meaning that there might be a significant under diagnosis and reported numbers of this STI.
    • This is especially concerning as trichomoniasis has been identified to increase risk of contracting HIV two- to three-fold, raising the need for tracking and treating much more important over the last several years.
    • Also, approximately 70% of all trichomoniasis cases are asymptomatic.
  • A 2019 KFF poll found that a large share of the public is unaware of how common STIs are, with far less than half (36%) aware that STI rates are increasing every year.

Support

If I need assistance with my product, whom do I contact?

If you have any questions with your product, please contact the Visby Medical Support Team for assistance at support@visby.com or 1-833-468-4729 (1-833-GoVisby)

What are CLIA-Certified Laboratories and Point of Care Settings?

Under CLIA, a laboratory is defined as a facility that performs applicable testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of human beings.

Point of care includes settings such as physician offices, urgent care, outpatient clinics, pharmacies, and patient care settings that operate under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

How does an entity obtain a CLIA Waiver?

For more information please visit: CLIA Waiver by Application | FDA