Arrayit Corporation (ARYC)

[MikeCr]

High-complexity laboratories developing their own tests, also called Laboratory Developed Tests or LDTs, must still have a CLIA certificate (provided by CMS) to legally develop a serology test. In addition, under the policy outlined by the FDA, they are performing their own validation and providing notification to the FDA, as well as following other labeling recommendations described in the March 16 policy. Developers of LDTs are still encouraged to seek authorization through an EUA.

"Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy"

https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy