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Visby Medical

San Jose, California, United Statesvisbymedical.com ↗

Ownership: Private
Employees: ~194
Development stage: Commercial

Overview

Visby Medical has developed the world’s first instrument-free, single-use PCR diagnostic platform that delivers lab-quality results in under 30 minutes. Its Sexual Health Click Test for women is FDA-cleared and CLIA-waived for point-of-care use; the company recently received FDA De Novo authorization for the first-ever OTC at-home PCR sexual health test. The COVID‑19/Flu test is also available under emergency use authorization. Clinical studies have demonstrated high accuracy comparable to central lab PCR tests.

Therapeutic areas: Infectious Diseases
Modalities: Molecular diagnostics (PCR-based)Point-of-care and at-home testing platforms
Industry: Molecular Diagnostics

Partnerships

CARB-X funding partnership to develop rapid diagnostics for antibiotic-resistant gonorrheaStrategic/commercial partnerships anticipated as per recent press releases

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