Here's another post:
Posted 04-10-10 on the RPC board:
with all due respect sir, you are frankly wrong. There is nothing specific about this test, they just have to give it a specific use to get 501k approval. It is liking taking the same broom and selling it as a "floor sweeper" and a "deck sweeper" and a "garage sweeper" under different labels; even though it is a general use broom.
From the CEO's own mouth:
"It's a general cancer screening test, the problem is that the FDA does not approve 'general cancer screening tests.' So we had to then focus on what type of cancer do we focus on in order to get approval by the FDA? the first thing we had to do is find a predicate device (A device recently cleared under 510(k) is usually used as a predicate device) and that predicate device was the CEA test for the monitoring of colorectal cancer (Note: the Carcinoembryonic Antigen test looks for certain tumor markers. The CEA is also used as a detector for other forms of cancer, including cancers of the rectum, lung, breast, liver, pancreas, stomach, and ovary. Not all cancers produce CEA, and a positive CEA test is not always due to cancer. Therefore, CEA is not used for screening the general population.)"
This explains why Dr. Moro is pursuing a specific type of cancer for approval.
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