FDA grants EUA for Watmind USA’s SpeedySwab Covid + FLU A&B self-test

Original from: Medical Device Network

Watmind USA has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its SpeedySwab Covid + FLU A&B Self-Test.

This authorisation enables over-the-counter (OTC) and point-of-care (POC) use, offering a rapid, simultaneous detection of Covid-19, as well as influenzas A and B.

Developed in collaboration with the National Institutes of Health’s Rapid Acceleration of Diagnostics Independent Test Assessment Program, the SpeedySwab Self-Test is claimed to provide a quick solution for at-home diagnostic testing.

Watmind USA stated that it aims to transform the landscape of at-home diagnostics with this latest offering.

The SpeedySwab OTC test is designed for symptomatic individuals aged two years and older, providing a quick method to determine the cause of their symptoms.

This test utilises Lateral Flow Assay technology, a cost-effective solution that is particularly valuable given the similar symptoms presented by Covid-19 and the flu.

The introduction of such a diagnostic tool is in line with wider efforts to increase the availability of testing options, the company stated.

This is especially important during flu seasons and in the event of potential Covid-19 spikes.

The SpeedySwab test’s ease of use and rapid results could play a crucial role in managing the spread of these viruses.

Watmind USA CEO Dan Davis said: “Receiving the EUA for our SpeedySwab test marks a significant milestone in our commitment to advancing public health.

“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. Watmind USA is proud to support critical public health initiatives.” 

Last month Biolabs International announced an exclusive distribution agreement for the COVID-19 + Flu A&B Antigen Test from Watmind USA.

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Source: FDA grants EUA for Watmind USA’s SpeedySwab Covid + FLU A&B self-test