Visby

Market position

Visby Medical states that the FDA authorized its product as the first at-home test for chlamydia, gonorrhea and trichomoniasis, the three most common curable STIs as identified by the Centers for Disease Control and Prevention.

The company positions its device against mail-in laboratory testing and clinic visits by combining PCR-level accuracy with a 30-minute on-site result, FDA authorization, discreet delivery, app-based private result reporting, and an included same-day telehealth pathway to treatment for positive results.

Technology

A single-use, handheld device that performs polymerase chain reaction (PCR) amplification at the point of use, described by the company as making laboratory-grade PCR possible at home. Results are reported in about 30 minutes through a companion password-protected app that also delivers muted, segmented video instructions.

Go-to-market

Direct-to-consumer online ordering via the company's website, supported by promotional discounts, customer reviews and testimonials, social media presence, and referenced partner relationships.

Individuals seeking private sexual health screening outside a clinical setting, including asymptomatic people; the company notes that most women and many men experience no symptoms from these infections.

Risks & controversies

Treatment decisions rest with third-party licensed providers rather than the company, and medication costs are not covered by the kit purchase. The panel is limited to three infections, and the company reports 98% accuracy rather than perfect concordance; user feedback referenced on the site includes at least one report of a delay in receiving results.