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Gold Seeker

02/12/11 7:37 PM

#2745 RE: Future Doc #2744

Future doc, I understand what you are saying but just because a poor test has become a standard of care does not mean another poor test will also become a standard of care.

As you clearly indicated in a prior post. PSA has become a standard of care and their are medical practices that solely survive on the use of that test and subsequent treatment. It is going to take a long time if ever to reduce the use of PSA.

If you go back to those first figures we discussed where Onko Sure was only better than a flip of a coin by 7%. It is better than 50% if the cancer is progressing and by that 7% it gained clearance by the FDA to monitor CRC cancer.

When the cancer is not progressing, the test is wrong 22% of the time but at least the cancer is not growing.

As for the new version that is undergoing trials, I don't think there will be a vast difference in false positives because most of the false positives from the current test are caused by elevated FDP from other issues. That is going to remain unchanged. I am sure the company will make it sound like the best test ever regardless of how it performs. The problem is that you will never see data that would normally be submitted for FDA clearance.