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news.AspenBio Pharma has reported that its FDA 510(k) clinical trial for AppyScore, the world's first blood-based diagnostic test for human appendicitis, has reached the 800 patient target and thereby has officially concluded enrollment in the study.
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Approximately more than 800 subjects have been enrolled in the independent, blind, multicenter study. The company estimates that four to six weeks will be required to allow its independent medical data management contractor to review and validate all final clinical and assay data, un-blind the study subject codes, and provide final data metrics for statistical analysis.
This data will then be forwarded to an independent medical statistician who will conduct statistical analysis and study results, to be then reported to the company for inclusion in its FDA 510(k) submission package. The company anticipates completing its FDA 510(k) submission in early 2009.
Richard Donnelly, president and CEO of AspenBio Pharma, said: “Achieving our 800 subject enrollment target in this trial is a key milestone for AspenBio Pharma. Analyzing the final data and successfully achieving FDA 510(k) clearance of our AppyScore appendicitis blood test is now our number one priority.
“While the actual final results of this blind trial will not be known for several more weeks, we are excited that this large AppyScore clinical trial has been completed. We look forward to sharing the results in early 2009.”