The COVID-19 outbreak has affected almost every facet of life which is why there is a section below on facts, forms, and other sources of information that you can review to help you understand Avellino’s response to SARS-CoV-2.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
HCP Fact Sheet
Patient Fact Sheet
Access the Avellino genetic counselor network
Contact Avellino for information on genetic counseling and learn how you can utilize the network to support your patients who need further explanation of their at-risk or positive results.