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MikeCr

05/04/20 2:58 PM

#195107 RE: MikeCr #195104

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.

https://www.washingtonpost.com/health/2020/05/04/fda-steps-up-scrutiny-coronavirus-antibody-tests-ensure-accuracy/
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theunclear1

05/04/20 2:59 PM

#195108 RE: MikeCr #195104

Good find. Thanks. Also, this site https://antibodycovidtest.com/ says: "Our laboratory is now offering this test while we await an official EUA status letter from the FDA."


https://www.washingtonpost.com/health/2020/05/04/fda-steps-up-scrutiny-coronavirus-antibody-tests-ensure-accuracy/
"If commercial test makers don’t submit applications for authorizations within the 10-day time limit, the agency plans to make that information public and consider enforcement action to take the products off the market."
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PennyStock Alert

05/05/20 12:28 AM

#195176 RE: MikeCr #195104

http://www.arrayit.com/

Website updated:

“Our healthcare pipeline includes finger stick tests for ovarian cancer, Parkinson’s disease, colon cancer, male fertility and now SARS-CoV-2 (COVID-19) Antibody.”