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<\/a><\/a>\nThe clearance comes as demand for at-home testing continues to grow, particularly for respiratory infections like COVID-19 and influenza, which send millions of people<\/a> to urgent care each year. Designed for home use, the Visby Medical Flu and COVID-19 Test helps consumers quickly test for COVID-19 and influenza A\/B so they have the test results to enable faster decisions about care, including whether to seek antiviral treatment or connect with a telehealth provider.<\/p> \n\u201cJust over a year after the authorization of our first at-home PCR test, we\u2019re expanding the same gold-standard PCR accuracy and 30-minute result to some of the most common respiratory infections,\u201d said Adam de la Zerda, founder of Visby Medical. \u201cWith the Visby Medical Flu and COVID-19 Test, consumers can test themselves at home, receive a real PCR result in 30 minutes, and make faster, more informed decisions about treatment and care.\u201d<\/p> \nUnlike antigen tests, PCR testing can detect infections earlier and at lower viral levels, making it the gold-standard for diagnosing respiratory infections like COVID-19 and influenza. Earlier detection is especially important because antiviral medications such as Paxlovid and Tamiflu are most effective when started early in the course of infection.<\/p> \n\u201cThe Visby Medical Flu and COVID-19 Test represents a meaningful advancement in access to highly sensitive molecular diagnostics for consumers,\u201d said Gary Schoolnik, Chief Medical Officer of Visby Medical. \u201cMore sensitive testing can help more patients access treatment during the window when antivirals are most effective, which can meaningfully impact outcomes for respiratory infections like COVID-19 and influenza.\u201d<\/p> \nThe Visby Medical Flu and COVID-19 Test builds on Visby\u2019s previously authorized at-home testing platform and further expands the company\u2019s growing over-the-counter diagnostics portfolio. It will be eligible for FSA and HSA reimbursement, consistent with Visby's currently available at-home testing product.<\/p> \nOver the past year, Visby has significantly expanded access to its at-home testing platform, with its STI test now available nationwide through partners including DoorDash, Labcorp, Quest Diagnostics, Wisp, Everlywell, and RAINN.<\/p> \nThis project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00019.<\/p> \nAbout Visby Medical\n