Visby Medical
Developer of an instrument-free, single-use at-home PCR diagnostic platform for consumer-directed sexual health screening. Offers an over‑the‑counter at‑home PCR test for chlamydia, gonorrhea, and trichomoniasis with reported lab-comparable performance in ~30 minutes, companion mobile app for guided testing and image-based result interpretation, integrated telehealth for positive results, and direct-to-consumer distribution including e-commerce, subscription purchasing, and on‑demand local delivery partnerships.
Industries
N/A
Nr. of Employees
small (1-50)
Patents
Molecular diagnostic devices with digital detection capability and wireless connectivity
US-12263478-B2
View DetailsPortable molecular diagnostic device and methods for the detection of target viruses
US-12037635-B2
View Details
Molecular diagnostic devices with digital detection capability and wireless connectivity
US-12263478-B2
View DetailsPortable molecular diagnostic device and methods for the detection of target viruses
US-12037635-B2
View DetailsProducts
Women’s at‑home single‑use PCR STI test kit
An over‑the‑counter, single‑use at‑home molecular test kit using a self‑collected vaginal swab to detect chlamydia, gonorrhea, and trichomoniasis with reported lab-comparable performance in ~30 minutes; results delivered via a companion mobile application. Retail pricing displayed on product pages has included a regular price of $179.99 and sale pricing at $149.99, with occasional promotional pricing reported to $99.00. Product available for purchase in the U.S.; intended for users 14 years and older.
Safe Access Program Test Kit
A palm-sized, FDA-authorized at-home PCR test kit providing lab-quality results for chlamydia, gonorrhea, and trichomoniasis in thirty minutes.
Visby Medical Sexual Health Test
A point-of-care rapid PCR device designed for self-collected vaginal swabs, delivering accurate STI test results in under 30 minutes without the need for separate instruments or readers.
Visby Medical App
Companion mobile application providing step-by-step guidance for at-home testing, secure access to test results, and telehealth support.
Women’s at‑home single‑use PCR STI test kit
An over‑the‑counter, single‑use at‑home molecular test kit using a self‑collected vaginal swab to detect chlamydia, gonorrhea, and trichomoniasis with reported lab-comparable performance in ~30 minutes; results delivered via a companion mobile application. Retail pricing displayed on product pages has included a regular price of $179.99 and sale pricing at $149.99, with occasional promotional pricing reported to $99.00. Product available for purchase in the U.S.; intended for users 14 years and older.
Safe Access Program Test Kit
A palm-sized, FDA-authorized at-home PCR test kit providing lab-quality results for chlamydia, gonorrhea, and trichomoniasis in thirty minutes.
Visby Medical Sexual Health Test
A point-of-care rapid PCR device designed for self-collected vaginal swabs, delivering accurate STI test results in under 30 minutes without the need for separate instruments or readers.
Visby Medical App
Companion mobile application providing step-by-step guidance for at-home testing, secure access to test results, and telehealth support.
Services
In‑app connection to third‑party licensed telehealth providers for consultation and possible prescription following a positive at‑home result; delivered via the companion mobile application.
In‑app connection to third‑party licensed telehealth providers for consultation and possible prescription following a positive at‑home result; delivered via the companion mobile application.
Expertise Areas
- At‑home molecular diagnostics
- Point‑of‑care PCR testing for consumer use
- Clinical validation and lay‑user usability testing
- Regulatory strategy and De Novo authorization for OTC diagnostics
Key Technologies
- Polymerase chain reaction (PCR) molecular diagnostics
- Instrument‑free single‑use microfluidic diagnostic devices
- Mobile app image analysis and automated result interpretation
- Cloud‑based digital health infrastructure (AI/ML‑ready)
News & Updates
Announcement of partnerships to expand distribution via consumer laboratory and digital health channels, enabling additional purchase and same‑day virtual care options.
Press release describing national launch, cloud infrastructure partnership, instant‑delivery pilot channels, and planned AI‑enabled product roadmap.
Announcement of FDA De Novo authorization for an over‑the‑counter at‑home PCR diagnostic for chlamydia, gonorrhea, and trichomoniasis; notes clinical studies and manufacturing readiness.
Received U.S. FDA De Novo authorization for an over‑the‑counter at‑home PCR test for detection of chlamydia, gonorrhea, and trichomoniasis.
Announcement of partnerships to expand distribution via consumer laboratory and digital health channels, enabling additional purchase and same‑day virtual care options.
Press release describing national launch, cloud infrastructure partnership, instant‑delivery pilot channels, and planned AI‑enabled product roadmap.
Announcement of FDA De Novo authorization for an over‑the‑counter at‑home PCR diagnostic for chlamydia, gonorrhea, and trichomoniasis; notes clinical studies and manufacturing readiness.
Received U.S. FDA De Novo authorization for an over‑the‑counter at‑home PCR test for detection of chlamydia, gonorrhea, and trichomoniasis.