As of Thursday May 21, Arrayit was still listed. See below:
Q: What laboratories are offering serology tests under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? (Updated 5/21)
A: As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to FDA, and information that helps users and patients understand the test results, such as the following, is included in the test reports:
This test has not been reviewed by the FDA.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
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.
This policy does not apply to at-home testing, including at-home specimen collection.
The laboratories in the list below have notified FDA that they have validated and intend to offer serology tests as set forth in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notifications submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.
If FDA becomes aware of concerns about a laboratory developed serology test that cannot be or have not been addressed in a timely manner, FDA intends to remove the laboratory from this list and may take additional actions as appropriate.
Laboratories that have notified FDA that they have validated and intend to offer serology tests as set forth in Section IV.D:
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Laboratory Authorization Status Settings for Use1
Arrayit Corporation Not FDA Authorized H
BioDiagnostic Inc. Not FDA Authorized H
Center for Cellular Therapy Medical University of South Carolina Not FDA Authorized H
DLS Research & Ventures Not FDA Authorized H
EDP Biotech Corporation Not FDA Authorized H
Emory Medical Laboratories Not FDA Authorized H
Enzo Clinical Labs Not FDA Authorized H
Genalyte, Inc Not FDA Authorized H
IGeneX Inc. Not FDA Authorized H
IMMYLabs Not FDA Authorized H
KSL Diagnostics Not FDA Authorized H
LabCorp Center for Esoteric Testing Not FDA Authorized H
OneBlood, Inc. Not FDA Authorized H
University of Arizona Genetics Core for Clinical Services Not FDA Authorized H
University of Minnesota Advanced Research and Diagnostic Laboratory Not FDA Authorized H
Vibrant America Clinical Labs Not FDA Authorized H
White Coat Sciences Not FDA Authorized H
Showing 1 to 17 of 17 entries
1 Settings for use include the following:
H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
W - Patient care settings operating under a CLIA Certificate of Waiver.
AI
