>>>Again, typically the PCA3 test is done after a negative biopsy
, that would have been prompted by an elevated PSA test. It is not indicated for use in place of, or in conjunction with PSA, as a screening test.<<<
Yes! “Intended Use.” Our test is going through the regulatory process with an intended use for screening – not diagnostic or prognostic or disease monitoring. There is no other genomic or proteomic test (that I know of) that is on its way to a screening approval for PC. Our test has the best chance of detecting something prostate cancer-like (sensitivity) and then specify this with an accuracy close to an actual visual/pathological exam. Really … no one is going to catch us.
>>>Bottom line is, the HDVY-Quest-Abbott PC screening test is very likely superior to the PCA3 test, both in sensitivity and specificity. Medicare should have no problem covering it, when it becomes available commercially (initially as a laboratory developed test). Do you concur, Mr Zeno?<<<
Yes again. PCA3 is still a work in progress according to the Medical Directors and reimbursement committees of some major payers. I think it’s a good adjunct test to diagnose the disease with a minimum of tissue snips. However, I don’t think it’s a coincidence that Abbott is spending resources to approve our tissue test. My guess is that the medical community will embrace the art of pathology (our tissue test) to establish a diagnosis for PC.
I do concur Sir asked for it regarding reimbursement. I will go one step further and say universal reimbursement will be the corollary of a screening approval … a standard of care which may or may not be shared with the clinically embedded serum PSA.
BTW, I applaud your wisdom in accumulating at these levels, but you ain't getting one share of mine.
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