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FDA Grants EUA for At Home Multiplex Rapid Test


The FDA grants emergency use authorization (EUA) for The CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test by CorDx. Designed to differentiate between influenza types A and B and SARS-CoV-2, this test is aimed at individuals experiencing symptoms of respiratory infections like COVID-19 within the first 5 days of symptom onset. Confirmation of results requires at least 2 applications over 3 days, with a mandatory interval of no less than 48 hours between tests.

Approved for individuals 14 and older for self-collection of nasal swab samples, and children 2 years old under adult supervision, this test enhances diagnostic capabilities in a convenient, at-home setting. The EUA is based on data provided by the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), a collaboration with the FDA to evaluate the effectiveness of COVID-19 diagnostics.

Introduced by the NIH Rapid Acceleration of Diagnostics (RADx®) Tech program, the ITAP aims to accelerate the regulatory review process and increase the availability of accurate, reliable, and high-quality diagnostic tests. This initiative marks a significant advancement in managing respiratory infections, combining ease of use with essential diagnostic functionality amidst ongoing public health challenges.

Reference

FDA Roundup: April 5, 2024. Published April 5, 2024. Accessed April 5, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-april-5-2024



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