Exact words by Mr. Quirk during the Quest webcast on 7/21/10
Operator
Thank you the next question is from Bill Quirk with Piper Jaffray.
William Quirk – Piper Jaffray
Yeah thanks, good morning guys, was wondering if you could comment Surya just on the recent FDA meeting on laboratory developed test, what that means for Quest, and how we should think about some of your own laboratory developed tests that you are going to be looking at moving to a manufactured kit or would you actually consider taking some of your products to FDA, thank you.
Surya N. Mohapatra
Now that’s a good question, our goal is the same as FDA goal we want to really create Test which are clinically tested and analytically valid and the only concern we have and we are working with our trade association and working with FDA that most of the test are laboratory developed test which brings innovation to the market place and we are regulated by clear and if we are not careful we don’t want FDA to over regulate us which will stop innovation and also not bring test to the market place so we are working with them to make sure what test are risky and obviously it has been exaggerated because some of these companies none are providing genetic testing. So I believe that we’ll come to a place where there will be a balanced between laboratory producing not very high quality test and the test which are not validated and the test which are high risk verses the majority of test which are safe and helping patients. Now as far as our company is concern we are very fortunate that we have lots of experience in creating products like H1N1 and other tests which we know how to go through the FDA, so obviously what about the position FDA takes we are very well positioned with the laboratory developed test and the test which might become caves because of our experience to focused diagnosing.
William Quirk – Piper Jaffray
And so just as a quick follow up Surya, is it safe to say it is little too early from your perspective to start ticking down a list of what test we might transition to a kit verses what we might take to FDA.
Surya N. Mohapatra
It is too early and I think there’s quite a bit of work to be done and I think FDA is having this hearing and we are working with them.
William Quirk – Piper Jaffray
Okay, very good thank you.