FDA Grants EUA to OTC COVID-19, Flu Combination Test

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The SpeedySwab COVID + FLU A&B Self-Test from Watmind is intended for at-home and point-of-care use and can simultaneously detect COVID-19, influenza A, and influenza B in 15 minutes.

The FDA has granted emergency use authorization (EUA) to an over-the-counter (OTC) 3-in-1 flu and COVID-19 test, biotechnology company Watmind announced in a news release.1 The test, which is intended for at-home and point-of-care use, can simultaneously detect COVID-19, influenza A, and influenza B in 15 minutes.

FDA Grants EUA to OTC Combination COVID-19, Flu Test / Araki Illustrations - stock.adobe.com

FDA Grants EUA to OTC Combination COVID-19, Flu Test / Araki Illustrations - stock.adobe.com

The SpeedySwab COVID + FLU A&B Self-Test was developed in partnership with the National Institutes of Health's Rapid Acceleration of Diagnostics Independent Test Assessment Program, an initiative that aims to speed up innovation in the development, commercialization, and implementation of COVID-19 testing technologies.2

READ MORE: Vaccination Prior to Initial Infection Reduced Risk of Post-COVID Condition

"Receiving the EUA for our SpeedySwab test marks a significant milestone in our commitment to advancing public health," Dan Davis, CEO of Watmind, said in a release.1 "As we navigate the ongoing challenges of COVID-19 and influenza A&B strains, our goal is to provide accessible and rapid at-home testing solutions that empower individuals to proactively manage their health from the comfort of their homes, while minimizing the spread of such diseases.”

The test is designed for individuals aged 2 years and older who have symptoms of COVID or the flu. It uses lateral flow assay technology, making it a low-cost and rapid tool that is easy to use through a step-by-step process.3 In its release, Watmind said the availability of the test, which comes in 1, 2, 4 and 25-pack options, is especially important during flu season and potential COVID-19 surges.

According to data from the CDC, the COVID-19 test positivity rate in the United States was 4.2% for the week ending May 25, up .8% from the previous week. Additionally, the emergency department visit rate for the same time period was .4%, up 5.1% from the week before.4 While COVID-19 cases are down substantially from the height of the pandemic, the disease still represents a threat to public health due to emerging variants.

READ MORE: COVID-19 Resource Center

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References
1. Watmind USA™ Receives FDA Emergency Use Authorization for SpeedySwab™ 15-Minute At-Home 3-in-1 Antigen Test for COVID-19, Flu A & B. News Release. Watmind. May 31, 2024. Accessed May 31, 2024. https://www.prnewswire.com/news-releases/watmind-usa-receives-fda-emergency-use-authorization-for-speedyswab-15-minute-at-home-3-in-1-antigen-test-for-covid-19-flu-a--b-302160165.html
2. RAPID ACCELERATION OF DIAGNOSTICS (RADX). NIH. Accessed May 31, 2024. https://www.nih.gov/research-training/medical-research-initiatives/radx
3. Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem. 2016 Jun 30;60(1):111-20. doi: 10.1042/EBC20150012. PMID: 27365041; PMCID: PMC4986465.
4. COVID Data Tracker. CDC. May 25, 2024. Accessed May 31, 2024. https://covid.cdc.gov/covid-data-tracker/#datatracker-home
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