Replies to post #195107 on Arrayit Corporation (ARYC)

[okwife]

YES!!! GO $$$$$$ ARYC $$$$$ WANT .0210 TODAY!!!

[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

[WebSlinger]

<< So high complexity CLIA labs like Arrayit's are not required to get EUA to sell their tests, although they are encouraged to do so. >>

The problem is that it looks like ARYC lost their CLIA license.

[ScorpGirl]

Calif Dept of Public Health - see map --about mid-way between Redwood City & San Jose - (Thompson Pl) - Off of E Arques Ave -- current as of April 2020.

https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/Laboratories-In-State-Map.aspx

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