Here is the news today, somewhat condensed to get to the key points:

IRIS International, Inc. announced today that it has received Institutional Review Board (IRB) approvals from Duke University Medical Center, Memorial Sloan Kettering Cancer Institute, Eastern Virginia Medical School and the University of Washington Medical Center to immediately begin a multi-center 300 patient retrospective randomized clinical study utilizing its NADiA(TM) ProsVue(TM) ultra sensitive prostate-specific antigen diagnostic assay.

The testing and analysis of 300 patients with serially collected blood samples, retained over an eight year period, is expected to be completed in approximately two months with the results to be incorporated into a FDA 510(k) application, which IRIS expects to submit late in the fourth quarter 2009.

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If you listed to the last conference call, starting at about 26.50 minutes in, the indication is that that they had the samples from two schools, and expected the samples from Sloan-Kettering and Duke in August. So here they are some 2.5 months behind. No explanation given.

In the last conference call, the FDA submission was to be in the end of the third quarter, and now it is to be the end of the fourth quarter.

What this means is that they have simply lost a quarter. On July 30 they say that they expect release of the samples within 30 days (in August), and it turns out to be late October. I suppose they will blame the schools.