Question-and-Answer Session
Operator
(Operator instructions).
Harry Stylli
Okay, operator. We are ready for the first question.
Operator
And your first question comes from Tony Butler with Barclays Capital.
Tony Butler – Barclays Capital
Thanks very much. Harry, three questions. One is what evidence do you have that the diagnostic test is validated at all? The second is, can you define a little more specifically what internal inquiries actually meant? How did you go about an internal series of questions and why did you do it? And the third question, please just review for us the large independent study that you are referring to, where you are in that process, how many patients, etcetera, do you anticipate again the timing? Thanks very much.
Harry Stylli
Tony, thank you for the questions. Because of confidentiality considerations and because the investigation is not complete, I am limited as to what I can say. But I can tell you this, regarding the large independent clinical studies which are ongoing, these are the Brown University study which is in a patient collection mode and the LDT study which is also in a patient collection mode. Between them, they involve about 15,000 patients and it is these studies, when they are executed, either more than likely in the first part of 2010 that we are likely to launch the test with. We expect to have a validated Down's Syndrome test by Q4 or in Q4 of this year.
Paul Hawran
Thank you, Tony.
Operator
Your next question comes from the line of Charles Duncan with JMP Securities.
Charles Duncan – JMP Securities
Hi. Harry, I had a question regarding really when you started to suspect or become concerned about the validation of the test. Can you give us more color on that and whether or not it was related to the presentation of data in January?
Harry Stylli
What I would say is that the data in question relates to data that goes back to June. The September and January releases of information, I believe that information is now suspect. And again, I am going to sort of repeat this. I can't really go into any of the details because of the confidentiality considerations of the investigation is not complete. That really ties my hands.
Charles Duncan – JMP Securities
Harry, I understand that but could you provide us any color on not necessarily the individuals of involved but the types of functions that they performed?
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