Aytu BioScience Inc. (AYTU)

[Dank02]

AYTU does not have an EUA. AYTU falls here. This is what is going to be modified. This most likely won't affect AYTU's right to distribute because other countries have already performed the tests to ensure accuracy so they have a lot to back up their tests.

Per FDA web page

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2


Q: Can I offer my SARS-CoV-2 antibody test kit in the US without an EUA?

A: As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, during the COVID-19 public health emergency, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

This test has not been reviewed by the FDA.

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

To help to ensure the above information is provided in the test report, as described in the guidance, commercial manufacturers could include this information in their Instructions for Use (IFU) or other labeling provided to laboratories.
As noted in the guidance, this policy does not apply to at home testing.
The commercial manufacturers and laboratories that have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019 are listed on this FAQ page under What serology tests are being offered under the policy outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019?.