Replies to post #190930 on Arrayit Corporation (ARYC)

[r2g2]

From: CDRH-EUA-Templates <[e-mail]>
To: CDRH-EUA-Templates <[e-mail]>; [e-mail] <[e-mail]>
Sent: Monday, April 13, 2020, 01:59:51 PM CDT
Subject: RE: Testing for virus ARYC

Hi Mr. G,
One serology test has been authorized; many manufacturers have notified the FDA.  I do not see this lab listed within our website.
Yvonne
 
EUA Authorizations
All in vitro diagnostic tests that have received an Emergency Use Authorization (EUA) are listed on FDA’s EUA Authorization page.
  
Serology Tests (Section IV.D.)
The commercial manufacturers and laboratories listed on our website have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. These tests have not been reviewed by FDA, and many of these manufacturers will not be pursuing FDA review and Emergency Use Authorization. This list is only intended to provide transparency about the manufacturer notifications FDA has received.
 
As noted in the guidance, the policies outlined in the Policy for Diagnostic Tests for Coronavirus Disease-2019 do not apply to at-home testing, including self-collection of samples to be sent to a clinical laboratory. The policy is limited to such testing in laboratories or by healthcare workers at the point-of-care. For each test offered under this policy, the manufacturer is expected to make it clear that:
 
·        The test has not been reviewed by the FDA.
·        Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
·        Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
·        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.
·        Not for the screening of donated blood
 




From: R G <[e-mail]> 
Sent: Monday, April 13, 2020 1:46 PM
To: Kahn, Jeremy <[e-mail]>
Subject: Testing for virus ARYC
 
Dear Mr. Kahn
I respect that you are very busy and simply wanted to inquire as to whether you have received an application for review of an antibody / finger prick test for COVID 19  from Arrayit Corp of Sunnyvale CA?
I believe they are a bona fide lab and am not writing to report any fraud.
 
R G
xxxx @yahoo.com