Visby Medical
Visby Medical develops rapid at-home molecular diagnostic tests powered by polymerase chain reaction (PCR) technology, focusing on accessible, private, and accurate screening for sexually transmitted infections (STIs). The company offers the first FDA-authorized over-the-counter at-home PCR test for women’s sexual health and is expanding its diagnostics platform to address other infectious diseases for point-of-care and home use. Its technology enables results in approximately 30 minutes via a secure mobile app, with integrated telehealth services for positive results. Visby Medical emphasizes user privacy, scalable manufacturing, and partnerships to broaden access to high-quality diagnostics.
Industries
N/A
Visby Medical
Patents
Molecular diagnostic devices with digital detection capability and wireless connectivity
2025-04-01 • US-12263478-B2
View DetailsPortable molecular diagnostic device and methods for the detection of target viruses
2024-07-16 • US-12037635-B2
View Details
Molecular diagnostic devices with digital detection capability and wireless connectivity
2025-04-01 • US-12263478-B2
View DetailsPortable molecular diagnostic device and methods for the detection of target viruses
2024-07-16 • US-12037635-B2
View DetailsProducts
An FDA-authorized, single-use molecular diagnostic device for at-home detection of chlamydia, gonorrhea, and trichomoniasis using a self-collected vaginal swab. Results are provided through a secure mobile application in about 30 minutes.
An FDA-authorized, single-use molecular diagnostic device for at-home detection of chlamydia, gonorrhea, and trichomoniasis using a self-collected vaginal swab. Results are provided through a secure mobile application in about 30 minutes.
Services
PCR-based at-home testing for chlamydia, gonorrhea, and trichomoniasis, offering mobile app guidance and telehealth consultations for positive results.
PCR-based at-home testing for chlamydia, gonorrhea, and trichomoniasis, offering mobile app guidance and telehealth consultations for positive results.
Expertise Areas
- At-home molecular diagnostics
- Women's sexual health testing
- Mobile health platform development
- Clinical validation and study design
Key Technologies
- Polymerase chain reaction (PCR)
- Single-use molecular diagnostic devices
- Self-collected vaginal swab sampling
- Mobile health application
Key People
Founder
Founder
News & Updates
Coverage of the FDA's approval of an at-home, over-the-counter PCR test for women’s sexual health.
Overview of new partnerships with national labs to make FDA-authorized at-home PCR STI testing more widely accessible.
Announcement of a partnership focused on cloud-based digital health solutions for rapid at-home STI diagnostics.
Received FDA De Novo authorization for an over-the-counter, at-home PCR test for sexually transmitted infections.
Established distribution partnerships with major laboratory providers to broaden access to at-home PCR STI testing.
Formed collaborations with digital health and logistics partners to enhance the availability of rapid at-home STI testing.
Coverage of the FDA's approval of an at-home, over-the-counter PCR test for women’s sexual health.
Overview of new partnerships with national labs to make FDA-authorized at-home PCR STI testing more widely accessible.
Announcement of a partnership focused on cloud-based digital health solutions for rapid at-home STI diagnostics.
Received FDA De Novo authorization for an over-the-counter, at-home PCR test for sexually transmitted infections.
Established distribution partnerships with major laboratory providers to broaden access to at-home PCR STI testing.
Formed collaborations with digital health and logistics partners to enhance the availability of rapid at-home STI testing.