Accelerated review pathway helps bring pair of at-home COVID-19 tests to U.S. market

Jan 04, 2022 - 03:11 PM
FDA product update

Two new COVID-19 home tests are now available to consumers in the U.S. Tests from SD Biosensor and Siemens in December gained Food and Drug Administration emergency use authorization, in part driven by the Department of Health and Human Services’ accelerated pathway to support FDA’s review of tests with potential for large-scale manufacturing. 
 
The SD Biosensor COVID-19 At-Home Test is authorized for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 or older, or adult-collected anterior nasal swab samples from individuals aged 2 or older. It should be noted that SD Biosensor’s test does not differentiate between SARS-CoV and SARS-CoV-2. The Siemens CLINITEST Rapid COVID-19 Antigen Self-Test for qualitative SARS-CoV-2 detection is designed for home use using self-collected anterior nasal swabs from individuals age 14 and older who are within the first seven days of COVID-19 symptom onset. The test is also authorized for those between the ages of 2 and 13 when an adult collects the nasal sample. Test results are available within 15 minutes of administration.
 

Related News Articles

Headline
AHA responds to FDA request for information on AI-enabled medical devices
The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of…
Headline
Permanent recall issued for Baxter ventilation system
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
CDC data shows rise in flu, COVID-19 cases across states 
Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19…
Headline
Recall issued for mislabeled potassium chloride
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled…
Headline
Study finds flu, COVID-19 infection temporarily raises risk of heart attack, stroke 
A study published Oct. 30 by the American Heart Association found that people have an elevated risk of heart attack and stroke following flu and COVID-19…
Headline
CDC adopts ACIP recommendations for COVID-19, chickenpox vaccines
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…