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WebSlinger

03/19/20 1:07 PM

#181690 RE: WebSlinger #181687

The FDA only approved 9 companies last night for Emergency Use Authorization. ARYC is NOT on that list.

Here is the list:

- CDC
- Abbott Molecular
- Quest Diagnostics Infectious Disease
- Quidel Corp
- LabCorp
- Hologic
- Thermo Fisher Scientific
- Roche Molecular Systems
- Wadsworth Center, NY State Dept of Health

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

Of course, now that the rumor has been disproved, the next rumor will be that ARYC is a partner for one of the above.

LOL...

caryS4

03/19/20 1:07 PM

#181691 RE: WebSlinger #181687

"States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA. Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA and are not required to pursue an Emergency Use Authorization (EUA) with the FDA."

https://globalbiodefense.com/2020/03/16/fda-pandemic-response-states-can-now-approve-covid-19-diagnostics-serology-testing/

BokehRebl

03/19/20 1:11 PM

#181696 RE: WebSlinger #181687

No FDA needed.. Arrayit is already an FDA approved company for their Allergy tests and from the looks of it, they simply rehashed that test into a Covid19 Blood Card to be sent to labs for quick turnaround testing.

Also “ President Donald Trump on Wednesday invoked rarely used emergency powers to marshal critical medical supplies against the coronavirus pandemic.”

This is a broad statement but many companies will be getting orders to ramp up productions of medical supplies, respirators, saline bags, prevention disinfection products... and most probably testing.

raspaman

03/19/20 1:14 PM

#181701 RE: WebSlinger #181687

Decisions are at the individual state level. you are looking in the wrong places.

CA can choose to allow any test the officials decide

whippinsaw

03/19/20 1:36 PM

#181729 RE: WebSlinger #181687

The authorizations are somewhat of a formality. FDA guidance issued earlier this week allows companies to manufacture and ship tests before receiving permission

This is in your post.

Its a formality