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Re: Alyssa post# 85342

Saturday, 06/16/2018 6:37:40 PM

Saturday, June 16, 2018 6:37:40 PM

Post# of 205136
I do agree that OvaDx is 10 years overdue, and it would be great if they got back its ownership and got it to FDA clearence. But to be realistic,
they left these hints since the beginning of the year, and in the Feb. tweet they mention 510(k).
That coupled with the fact that the 100% score on Proficiency Testing Conducted by the College of American Pathologists CAP PT is in the highly quantitative measurements of IgE. (allergy).
And the PR re CLIA certiifcation said
"Arrayit has developed patented and proprietary microarray technology, validated through the CLIA program, to measure immunoglobulin E (IgE) and immunoglobulin G (IgG) levels for the purposes of allergy and dietary wellness testing."

This all means that they are in the allergy track this year.

26 Jan 2018
Arrayit completes site visit and laboratory tour with a key business-to-business B2B partner and regulatory consultant regarding submission of a proprietary microarray product line to the United States Food and Drug Administration for FDA clearance

26 Feb 2018
Arrayit clinical team assembles technical documents for a major microarray technology product line in preparation for 510(k) clearance submission with the United States Food and Drug Administration FDA

Mar 14 2018
Arrayit clinical team submits requested standard operating procedures SOPs and other documentation required for submission of a major microarray technology product to the United States Food and Drug Administration FDA for FDA regulatory clearance https://www.fda.gov

17 May 2018
Arrayit clinical team confirms meeting with the United States Food and Drug Administration FDA to discuss FDA clearance of a major product line. The FDA is headquartered in Silver Spring Maryland USA and improves healthcare by ensuring public safety

May 29 2018
Arrayit CLIA clinical team confirms 7/2/2018 meeting with top officials at the United States Food and Drug Administration FDA headquartered in Silver Spring Maryland USA to discuss FDA regulatory clearance of a major microarray technology product line