More on the PCA3 test

In developing our earlier article on the PCA3 test (on Sunday), we should have made it clear that, despite the fact that Gen-Probe’s Progensa PCA3 assay is not yet commercially available in the USA, it absolutely is possible for patients to have the PCA3 test carried out — and in most cases this will be covered by insurance carriers!

Selected specialty laboratories in the US are capable of conducting this assay under what is known as an “analyte specific reagent” or ASR protocol, which does not require FDA approval. Different laboratories have given their own names to this test. Thus, for example, Dianon Systems offers this test as the CapDetect:PCA3 test and Bostwick Laboratories offers the test under the name PCA3Plus.

If individual patients are interested in having this test carried out, they should do one of two things:

  • Ask their urologist if (s)he works with a laboratory that can carry out this test or if (s)he could contact a laboratory capable of carrying out this test to get information about specimen protocols for urine collection and transport — and make sure that the test is covered by your insurance carrier.
  • Contact the testing laboratory directly and get information about specific physicians that those laboratories are already working with in carrying out their version of the PCA3 test.

We understand that, at this time, the test does have to be conducted under the supervision of a urologist due to the collection procedures required.

The “New” Prostate Cancer InfoLink wishes to be clear that, although extensive data have been published about the PCA3 test, there are, as yet, no nationally approved guidelines about interpretation of PCA3 data in the USA, so all results of PCA3 assays should be assessed with due caution at the present time.

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