Replies to post #94560 on Arrayit Corporation (ARYC)

[Starlight84]

Dear Stevenson, Thanks for your continued support and feedback. The summer timeframe is an Arrayit estimate based on our extensive experience with auditors and audits. We continue to have confidence in that estimate. Thanks, Mark

[StockDetective]

USDA

A fast, simple and high throughput array-based method for typing pathogens will be developed. Capture probes will be designed to target norovirus and hepatitis A virus, clinically-important Salmonella serovars and Campylobacter spp. To evaluate probe specificity, viral RNA or bacterial DNA will be extracted from clinical samples or cultured strains. A Cooperative Research and Development Agreement (CRADA) has been established with Arrayit Corporation to develop a fast, simple, and cost-effective test, in conjunction with inexpensive instrumentation.

Project Number: 2030-42000-051-00-D
Project Type: In-House Appropriated

Start Date: Feb 25, 2016
End Date: Feb 24, 2021

https://www.ars.usda.gov/research/project/?accnNo=430420

[StockDetective]

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FDA
1-2-18: 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 https://www.fda.gov

3-14-18: 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

5-17-18: 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 fda.gov

5/29/2018: 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 (link: https://www.fda.gov) fda.gov

Arrayit provides 7/2/18 FDA update: (1) excellent meeting, (2) large attendance by FDA top brass, (3) insightful and instructive, (4) our entire clinical team wishes to thank the agency for their feedback and generosity, and (5) we believe that our test will receive FDA approval.

7/16/2018: Arrayit Corporation Reports Clinical Instrumentation Sale to the FDA.