We have just come across the first patient we know of to be given an Apifiny test for risk of prostate cancer. He had an Apifiny score of 89 — but quite what that might mean seems to be a little unclear (as is why this particular patient was given the test, since he is 81 years of age but, as yet, we don’t know his PSA level).
To quote the information being distributed by Armune Biosciences, the developer of the Apifiny test, this test
may be used in men who have an elevated PSA (> 2.5 ng/ml) and are considering a prostate biopsy.
If the Apifiny score is 59 or less, then the patient is supposedly at “lower” risk for prostate cancer and if the score is 60 to 100 then the patient is at “higher” risk. The implication is that a man with an Apinify test score of < 60 probably doesn’t need a biopsy (if there are no other indicators of risk). Of course the unanswered question is whether a man at higher risk is also at higher risk for prostate cancer of any type (indolent disease included) or whether the Apifiny score tells us anything at all about risk for clinically significant disease.
The information available from Armune at this time is limited. We were able to find the following on or via the company’s web site:
- A brief piece of promotional information intended for physicians that tells us almost nothing beyond the points made above.
- Some information for patients which is similarly uninformative.
- An article from the journal Translational Oncology stating that the authors have developed an algorithm that can be used in association with the Apifiny test “to indicate a relative high or low risk of [prostate cancer], particularly for patients with intermediate (4.0 to 10 ng/ml) PSA levels.”
- The abstract of an article from the New England Journal of Medicine about the Apifiny test that we have mentioned previously.
We want to be very clear that the Apifiny test may well be very useful. It was developed in association with Arul Chinnaiyan and others at the University of Michigan who most certainly know what they are doing. However, if the Apifiny test really is going to have practical, routine value in the diagnosis of prostate cancer, then (in our humble opinions) both doctors and their patients need some better guidance about the implications of the results of the test!
Filed under: Diagnosis, Risk | Tagged: Apifiny, risk, test |
THE "NEW" PROSTATE CANCER INFOLINK 
In Armune’s literature, they tell us that at a cut point of 59, the positive predictive value is 0.34 and the negative predictive value is 0.88. This means that two-thirds of men who are sent to a biopsy on the basis of this test will turn out to be negative for prostate cancer. On the other hand, only 12% of the men who are told by the test that they do not have prostate cancer, will indeed be found to have it if they have a biopsy anyway. It is really no better than %free PSA at a cut point of 10%, but not as good as phi or PCA3. For a cost of over $300, this is not a very good test.
Thanks Allen … I didn’t find that piece of physician-directed literature in my quick review.
I recently scored a 99 on the Apifiny test. Informed a couple of days ago that the biopsy was negative for cancer. One data point, for what it’s worth.