Replies to post #23271 on DNAprint Genomics (DNAG)

[DorseyE]

Forgive me frogdreaming, I don't like the way that sounds....
could you please share your thoughts on the statement?

[Blue Juggernaut]

Hey Dorsey,

Sorry to jump in on your request to Frog....but I do not think that the subject is open for opinion.

Since the FDA came out with its new guidence (IMO) its been clear that DNAP would have to apply for a 510K for Stat. and Ov. Check out #2 below. Number 2 appears to speak directly to DNAP's genomic-based diagnostic tests. Although, the 10 was just released it is my hope that they wrote their statement about further FDA guidence prior to the new guidelines coming out.

If you're interested in looking into it further you can check CFR 312.23. The info below is from: http://www.fda.gov/cder/genomics/decisionTree.htm

Big, I love this stuff, Blue


Pharmacogenomic data must be submitted to the IND under CFR 312.23 if ANY of the following apply:

1. The test results are used for making decisions pertaining to a specific clinical trial, or in a animal trial used to support safety (e.g., the results will affect dose selection, entry criteria into a clinical trial safety monitoring, or subject stratification).

2. A sponsor is using the test results to support scientific arguments pertaining to, for example, the pharmacologic mechanism of action, the selection of drug dosing, or the safety and effectiveness of a drug.

3. The test results constitute a known, or probable, valid biomarker for physiologic, pathophysiologic, pharmacologic, toxicologic, or clinical states or outcomes in humans, or is a known valid biomarker for a safety outcome in animal studies. If the information on the biomarker (example, human CYP2D6 status) is not being used for purposes 1 or 2 above, the information can be submitted to the IND as an abbreviated report.