Will “Apifiny” be helpful in the diagnosis of prostate cancer?

The development-stage test known as Apifiny is a new type of test that its creators believe will help in the more accurate diagnosis of prostate cancer. Whether that is actually the case seems to be rather less certain as yet.

According to Armune BioScience, a Kalamazoo, Michigan-based company that is developing the Apifiny test, the test uses a simple blood sample and can measure the levels of cancer-specific autoantibodies in such blood samples. The initial goal would be to be able to use this test in men who had a negative result on an initial biopsy but who were still suspected of being at significant risk for prostate cancer.

Several other tests already offer capabilities in this setting, including many of the genomic and genetic tests that are already on the market. This makes one wonder why it might not be wiser to look at a test like the Apifiny test as an immediate follow-up to a PSA test to determine whether a biopsy was actually worth considering at all.

According to one news report the company is hoping to be able to launch the Apifiny test early in 2015. However, it seems very unclear as yet exactly what a clinician would know based on the results of this test. The presence of autoantibodies to prostate cancer might mean only that a patient has a very small focus of Gleason 6 prostate cancer, in which case there are real questions about whether a repeat biopsy is a good idea — particularly in older men with a relatively short life expectancy.

Having said that, data supporting the accuracy of this type of test were published by Wang et al. back in 2005 in The New England Journal of Medicine. There is clearly relevant science behind the concept. The question is going to be one of precise clinical utility and value.

One Response

  1. PHI costs $60 and is covered by Medicare and insurance, or is guaranteed to be covered. PCA3 is FDA-approved only after a first negative biopsy where suspicion remains and costs $300 to $400. The MiPS test, combining TMPRSS2:ERG fusion with PCA3, costs $750. Apifiny costs $300 to $400 and is not yet FDA-approved, and there is no guarantee yet that any insurance will cover it. The 4KScore is in the same price range. The goal of all of these is to prevent unnecessary biopsies. I hope Armune will come down in price to achieve better value for the money. It’s probably less expensive to foot the bill for the co-pays and deductibles on a biopsy than to get an inconclusive blood test costing this much out-of-pocket that may lead to a biopsy anyway.

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