First Authorized Test Approved by FDA

The Food and Drug Administration on Thursday authorized its first emergency use coronavirus serology test.

Cellex Lateral Flow Test

The test was developed by Cellex Inc. and involves a blood draw done at a certified lab. It can provide results in 15 minutes.

FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19,” FDA chief scientist Denise M. Hinton said, adding “The known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.”

The test will determine whether an individual has developed antibodies to the virus, which would be detectable within days of initial infection, and will be used on people who are suspected of having the virus.

Becton, Dickinson and Co. and BioMedomics earlier this week announced a similar antibody test but has yet to receive the FDA’s emergency approval. To see complete list of companies applying for approval. See Link.

Antibody testing differs from the testing being done to determine whether individuals are suffering from coronavirus, which involve nasal swabs.

source. IBT

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