Doc, you seem to be "hung up" a little on the sensitivity/specificity aspect of the test. That applies mainly to the performace of the test in general.
What the FDA would be concerned with is the performance of the test when monitoring CRC. If I remember correctly, the test was accurate about 78% of the time when a negative result correctly indentified the cancer as not progressing.
When the cancer was progressing, the test was accurate 74% of the time. Both of those numbers would be the reference for the 5% change the FDA would allow.
One thing for sure. The company did not disclose the results of the first trials that ended in late 2009 that allowed them to change the antibody without obtaining a new approval from the FDA.
If it was really good, they would have been elated to apply for a new approval and screamed to the high heavens how great the new test was. As it stands, they did not say anything at all so I would have to say there was little or no improvement in the test.
Doc, do you agree with that assessment? This company is all about PR and hype. Silence is NOT GOOD.
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