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Wednesday, 05/25/2011 11:49:02 AM

Wednesday, May 25, 2011 11:49:02 AM

Post# of 30046
Future doc.

This is from the 10K. How can you have valid study results when you eliminate 50 samples because they did not produce any FDP values? According to the first statement below, they all had CEA values. What gives here?

"MVSS provided 976 biospecimens and annotation that MVSS tested with the standard CEA cancer screening test. We then took the biospecimens and tested them using the Onko-Sure® cancer screening test on March 4, 2011. We submitted the data from our Onko-Sure® measurement tests, along with the CEA tests MVSS performed on the same samples to a third party statistical analysis firm. The statistical analysis of the study was completed on April 25, 2011. Based on the final trial analysis, it was determined Onko-Sure® is a useful tool in the detection of colorectal cancer (“CRC”) in all stages, and specifically, in early Stages I and II where effective diagnosis can lead to better patient prognosis. Additionally, the study demonstrated Onko-Sure® IVD cancer test can be up to 13-17% more effective in detecting and/or monitoring CRC in Stages I and II over CEA. Furthermore, the study showed that when Onko-Sure® is combined with CEA, the sensitivity of the combined tests delivers additional increased sensitivity to physicians and their patients as opposed to using CEA alone.
The trial was performed using retrospective clinical samples from a total of 926 serum samples with 446 healthy volunteers and 480 colorectal cancer patients (approximately 50 of the originally provided biospecimens did not provide any values so the final data set included 926 samples). We plan to disseminate these results in a peer-reviewed journal, either independently or with other third party healthcare organizations. Additionally, we plan to present these results to physicians at international oncology conferences and scientific meetings."







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