SAN JOSE, California, July 2, 2026
Visby Medical has received U.S. Food and Drug Administration (FDA) clearance for the Visby Medical Flu and COVID-19 Test, becoming the first at-home polymerase chain reaction (PCR) test capable of detecting multiple respiratory viruses in a single over-the-counter device. The newly cleared diagnostic enables consumers to test for COVID-19, Influenza A, and Influenza B using laboratory-quality molecular technology while receiving results in approximately 30 minutes from the comfort of their homes. The milestone represents Visby Medical’s second FDA-cleared over-the-counter PCR test and significantly expands the company’s growing portfolio of rapid molecular diagnostics designed to improve access to accurate infectious disease testing. By combining gold-standard PCR sensitivity, instrument-free technology, and immediate telehealth connectivity, the innovative test enables earlier diagnosis and faster treatment decisions during respiratory virus seasons, reinforcing the growing role of decentralized molecular diagnostics in modern healthcare.
First At-Home Multi-Virus PCR Test Expands Diagnostic Access
The Visby Medical Flu and COVID-19 Test represents a major advancement in consumer molecular diagnostics, delivering laboratory-quality PCR testing without requiring specialized laboratory equipment or clinical visits. Unlike traditional rapid antigen tests, which may have reduced sensitivity during the early stages of infection, PCR technology detects viral genetic material at much lower viral concentrations, enabling earlier and more accurate diagnosis. The test simultaneously identifies SARS-CoV-2, Influenza A, and Influenza B, allowing individuals experiencing respiratory symptoms to determine the likely cause of illness using a single home-based test.
The portable, single-use device produces results within 30 minutes, helping patients make timely healthcare decisions regarding isolation, antiviral treatment, or consultation with healthcare professionals through integrated telehealth services. As respiratory viruses continue to contribute to millions of healthcare visits annually, broader access to highly sensitive at-home molecular testing has the potential to improve patient outcomes while reducing unnecessary emergency department and urgent care utilization.
Early Detection Supports Faster Treatment Decisions
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The availability of high-sensitivity PCR testing at home offers significant clinical advantages by identifying infections during the earliest stages of disease, when antiviral therapies such as treatments for COVID-19 and influenza are most effective. Earlier diagnosis enables patients to seek medical advice and begin treatment within recommended therapeutic windows, potentially reducing disease severity and limiting transmission. According to Visby Medical, the newly cleared test integrates immediate telehealth connectivity, allowing consumers to rapidly discuss results with healthcare providers and receive guidance on appropriate treatment options.
The test will also be eligible for Flexible Spending Account (FSA) and Health Savings Account (HSA) reimbursement, improving accessibility for consumers seeking convenient, high-quality diagnostic solutions. This latest regulatory clearance builds upon the company’s previously authorized at-home PCR platform, demonstrating continued expansion of molecular testing beyond traditional laboratory settings into routine home healthcare.
FDA Clearance Strengthens Molecular Diagnostics Innovation
The FDA clearance reinforces Visby Medical’s leadership in developing rapid molecular diagnostic technologies that combine laboratory-grade performance with user-friendly home testing. Founded to expand access to infectious disease diagnostics, the company has pioneered instrument-free, single-use PCR technology capable of delivering reliable molecular test results in a compact handheld format. Over the past year, Visby has expanded nationwide access to its over-the-counter testing platform through multiple healthcare and diagnostic distribution partners while continuing to broaden its product portfolio.
The newly cleared Flu and COVID-19 Test further strengthens the company’s position within the rapidly evolving point-of-care and at-home diagnostics market, where demand for highly accurate, decentralized testing continues to grow. As healthcare systems increasingly prioritize early detection, personalized care, and digital health integration, Visby Medical’s innovative PCR platform demonstrates how advanced molecular diagnostics can improve disease management, accelerate clinical decision-making, and support better public health outcomes through accessible, laboratory-quality testing performed entirely at home.
Source: Visby Medical press release
