US-based health diagnostic testing solutions provider Watmind USA has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its SpeedySwab Covid + FLU A&B Self-Test.
The SpeedySwab is authorised for both over the counter (OTC) and point-of-care (POC) use.
Watmind developed the test in partnership with the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program (ITAP).
It is designed to help symptomatic individuals aged two years and above rapidly test whether their symptoms are due to Covid-19, Influenza A, or Influenza B.
The FDA authorisation provides a rapid solution for at-home testing that simultaneously detects Covid-19, Influenza A, and Influenza B.
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.”
According to the company, the test employs advanced Lateral Flow Assay (LFA) technology, and a simple format facilitates self-administration on adults, or by adults on children.
SpeedySwab Covid + FLU A&B Self-Test is highly sensitive and easy-to-use, and provides rapid, reliable results within 15 minutes, using a user-friendly step-by-step process.
Its reliable design detects proteins from SARS-CoV-2 (Covid-19) variants and subvariants.
The test provides a cost-effective option at a time when distinguishing between the overlapping symptoms of these viruses is challenging, said the diagnostic tests provider.
Watmind is engaged in developing advanced medical diagnostic solutions in partnership with governmental agencies and leading healthcare companies.
