DNAprint Genomics (DNAG)

[worktoplay]

novicetx...Didn't mean to put words in your mouth, just drawing an inference from several sources.

We have heard from DNAP that the process of developing a market for their products would involve initially performing the testing themselves. This has three primary benefits. The FDA would allow them to market the test as long as THEY were performing the testing, as opposed to packaging and selling a kit through a third party. Secondly, they can establish a market which, in turn, helps establish a value for purposes of negotiation with potential marketing partners down the road. Thirdly, introducing the test in this fashion will make eventual FDA approval less cumbersome.

But in order to offer this testing service in a clinical setting, they must first pass regulatory muster. Thus, the reason that Tony said in the TWST article that the company is going through that process now. He stated in the article that they expect to have their clinical genotyping operations up and running by the end of the year.

Finally, he would not be able to offer that test to you if they have not completed the regulatory approval process. I wasn't drawing anything specific from your post alone, but it helped clarify (in my own mind at least) why they are seeking regulatory approval to do clinical work.

Later,
W2P