Aytu BioScience Inc. (AYTU)

[Aprice125]

The FDA is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 infection. While the FDA remains open to receiving submissions for these tests for such uses, based on the underlying scientific principles of antibody tests, the FDA does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection.

Recommendations
The FDA recommends health care providers:

Continue to use serological (antibody) tests, as appropriate, and be aware of their limitations.
Do not use serological (antibody) tests as the sole basis to diagnose COVID-19 but instead as information about whether a person may have been exposed.
Be aware that not all marketed serological tests have been evaluated by the FDA. The FDA’s authorized tests, including serological tests, are listed on the Emergency Use Authorization (EUA) page. Tests being offered under a policy outlined in the FDA’s COVID-19 Diagnostic Policy Guidance are listed on our FAQ page. Such tests have not been reviewed by the FDA, unless an EUA has also been submitted and reviewed by FDA.

https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers










Approved by FDA found here. AYTU not ON THIS LIST.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations