Kevin T. Conroy
Thanks, Maneesh. We're very pleased to announce that we have enrolled 9,000 patients into the clinical trial. I want to complement the entire team in Exact for keeping enrollment on track. Enrolling 9,000 patients into a colorectal cancer study is no small undertaking.
Colonoscopy and pathology reports have been completed for approximately 6,000 patients. The pathology data for roughly 3,000 patients are in process. The final pathology report determines whether an enrolled patient has cancer.
Our goal is to enroll 49 to 56 patients with colon cancer. To date, our cancer accrual in the study is in line with expectations. We have already enrolled more than 400 patients with advanced adenomas or pre-cancers, which more than adequately powers the study for pre-cancer sensitivity. Assuming that our cancer incidence rate remains on par with the rate so far, we expect to complete the study and make our FDA submission per our guidance, the manufacturing module in the fourth quarter and the clinical analytical modules together in the first quarter of 2013 per FDA's request.
Let's turn to our recently completed cutoff study. The cutoff study or our final DeeP-C training sets involve more than 900 patients, including more than 80 cancer patients and 70 pre-cancer patients. We are very pleased with the results of the study. The results are in line with previously released data and we look forward to presenting this new data at a fall 2012 scientific meeting. These data are being used for final confirmation of the cutoff criteria for the assay.
Two important things to note about the cutoff study. First, the patient samples were processed on the automation system that will be part of the DeeP-C study and represents our commercial high-volume solution. The study validated the robust performance of our instruments. Second, this is the third set of data that meets or exceeds our expectations, which increases our confidence even further as we head towards testing the DeeP-C samples later this year.
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