Erthang, a 510k could be possible but a long shot. Things have changed at the agency in the past year after vioxx. They have become much more conservative and issuing a lot of "approvables". If you are not familiar with that term, it is not good. IMO, no one in the agency is going to stick their neck out and approve a 510k. Once they get this test approved, other cancer indications could come under that rule.
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