Replies to post #89958 on Arrayit Corporation (ARYC)

[caryS4]

It's a complicated process to get FDA approval but Arrayit is progressing along really nicely. Here's more detail about the process:

https://www.marsdd.com/wp-content/uploads/2012/09/Pathway-to-Commercialization-for-an-In-Vitro-Diagnostic-in-the-US.pdf

I think Arrayit's test(s) are considered Class 1 (low risk) LDT (lab developed test) so approvals shouldn't take as long as the higher risk tests (Class 2 and 3).