Arrayit Corporation (ARYC)

[MikeCr]

Don't feel bad. The FDA guidelines for the covid-19 antibodies tests have been confusing. There are now 179 manufacturers and 20 high complexity labs selling tests in what some people have called a "wild west" of tests.

The FDA has been criticized for allowing tests that are not even accurate to be sold. Doctors are confused as to which tests are good. That's why the FDA continues to fine tune the guidelines.

Arrayit fits in the lab the category below. They are not required to get Emergency Use Authorization (EAU) but they are encouraged to do so.:

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.

Access Medical Laboratories
Arrayit Corporation
BioDiagnostic Inc.
DLS Research & Ventures
EDP Biotech Corporation
Emory Medical Laboratories
Genalyte, Inc
HealthQuest Esoterics
IMMYLabs
Lenco Diagnostic Laboratory
Mayo Clinic
Michigan Health Clinics
National Jewish Health
Otogenetics
Progenesis, Inc.
Rady Children's Hospital - San Diego
Roseland Community Hospital/American Medical Lab
Vibrant America Clinical Labs
VRL Eurofins

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