Visby Medical, Inc.
Visby Medical is a diagnostics company dedicated to transforming infectious disease diagnosis and treatment through innovative, portable PCR testing technology. Their mission is to make access to rapid, accurate testing easy and accessible, enabling clinicians to deliver same-visit diagnosis and treatment for serious infections, including sexually transmitted infections and COVID-19. They develop palm-sized, single-use PCR diagnostic devices that provide fast, accurate results at the point of care, including in resource-limited settings and for at-home use. Their technology has received multiple FDA clearances, CLIA waivers, and emergency use authorizations, and they actively participate in public health and medical conferences to showcase their innovations.
Industries
Nr. of Employees
medium (51-250)
Visby Medical, Inc.
San Jose, California, United States, North America
Products
Single-use point-of-care PCR test for sexually transmitted infections (women)
Disposable, instrument-free PCR assay designed for detection of common sexually transmitted pathogens from self-collected vaginal specimens with results delivered during the patient visit.
Single-use point-of-care PCR respiratory panel
Disposable, instrument-free multiplex PCR assay for detection and differentiation of respiratory pathogens with rapid turnaround for point-of-care use.
Pooled-sample RT-PCR workflow for laboratory use
Instrument-free RT-PCR assay and associated pooled-sample protocol authorized for laboratory workflows that combine multiple patient specimens into a single test device.
OTC-format single-use PCR test for sexual health (consumer)
Over-the-counter single-use PCR test format for at-home detection of selected sexually transmitted infections, authorized via a consumer diagnostic regulatory pathway.
Single-use point-of-care PCR test for sexually transmitted infections (women)
Disposable, instrument-free PCR assay designed for detection of common sexually transmitted pathogens from self-collected vaginal specimens with results delivered during the patient visit.
Single-use point-of-care PCR respiratory panel
Disposable, instrument-free multiplex PCR assay for detection and differentiation of respiratory pathogens with rapid turnaround for point-of-care use.
Pooled-sample RT-PCR workflow for laboratory use
Instrument-free RT-PCR assay and associated pooled-sample protocol authorized for laboratory workflows that combine multiple patient specimens into a single test device.
OTC-format single-use PCR test for sexual health (consumer)
Over-the-counter single-use PCR test format for at-home detection of selected sexually transmitted infections, authorized via a consumer diagnostic regulatory pathway.
Services
Clinical implementation support and materials
Provision of implementation materials, case studies, webinars and resources to integrate point-of-care molecular tests into clinical workflows.
Clinical implementation support and materials
Provision of implementation materials, case studies, webinars and resources to integrate point-of-care molecular tests into clinical workflows.
Expertise Areas
- Point-of-care molecular diagnostics
- RT-PCR assay development and multiplexing
- Clinical validation and implementation studies
- Regulatory strategy for diagnostics (EUA, 510(k), CLIA waiver, De Novo)
Key Technologies
- Reverse transcription PCR (RT-PCR)
- Nucleic acid amplification tests (NAAT)
- Multiplex PCR
- Single-use cartridge-based assays