FDA grants EUA to Siemens Healthineers’ over-the-counter rapid COVID-19 test

Siemens Healthineers (ETR:SHL) announced that it received FDA emergency use authorization (EUA) for its Clinitest COVID-19 diagnostic.

Tarrytown, New York-based Siemens Healthineers can now offer the Clinitest rapid COVID-19 antigen self-test over the counter as the need for COVID-19 testing rises in the U.S.

According to a news release, the company designed the nasal swab test to aid in the rapid detection of SARS-CoV-2 (the virus causing COVID-19) with visually read test results delivered in 15 minutes. Authorization covers self-testing for individuals aged 14 years and older or adult-collected samples from individuals aged two to 13.

Siemens Healthineers expects the test to be made available in January, having secured dedicated production capacity for U.S.-bound tests in the range of tens of millions per month.

“Undetected COVID-19 exposure is a major driver of community spread. With the Clinitest rapid COVID-19 antigen self-test, consumers will have access to a fast, reliable, and convenient test to provide additional safety,” Siemens Healthineers Head of Point-of-Care Diagnostics Christoph Pedain said in the release. “Siemens Healthineers is proud to bring this high-quality test, already used and trusted by families, medical professionals, businesses and governments in many parts of the world, to the United States under FDA emergency use authorization.”

Original Article: (https://www.massdevice.com/fda-grants-eua-to-siemens-healthineers-over-the-counter-rapid-covid-19-test/)