Arrayit Corporation (ARYC)

[MikeCr]

I wouldn't say that ARYC has the FDA "blessings" to sell the ovarian cancer screening test as an LDT test.

For years they were pursuing PMA FDA APPROVAL for screening then they changed the strategy to pursue 510k FDA approval for monitoring.

Can they get away with offering the test now as LDT?

The FDA is concerned about tests that could cause harm, like telling someone incorrectly that they have cancer and go through unnecessary dangerous procedures