Overall, multiparametric MRI is probably the most transformative development in the context of prostate cancer detection. Loeb herself is a proponent of multiparametric MRI in the PCa diagnostic space: Loeb expressed caution: “Additional studies are needed to compare IsoPSA to other commercially available prostate cancer markers in this space,” before its potential use as a second-line test to help men decide on a biopsy. Stacy Loeb (NYU Langone Medical Center), considers the PHI and 4K score to be “most useful second-line tests in screening since they are like new and improved versions of PSA itself.” Regarding the 2017 initial results of IsoPSA research, Dr. There are several widely used biomarker tests that enlarge upon information from blood or biopsy tissues, such as the PHI (Prostate Health Index), the 4K score, Prolaris, OncotypeDX, Decipher, etc. The bad news is, there is no sign yet that the FDA has actually approved the test for market distribution. This move sprang from results of a 2019 validation study, which closely matched the first. Then, in October 2019, the FDA granted breakthrough device designation to the test, in order to work closely with the manufacturer to expedite approval. In September, 2018 we posted a blog on this promising news of the IsoPSA blood test for prostate cancer (PCa).