ENGLEWOOD, Colo., Nov. 17, 2016 /PRNewswire/ -- Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today announced that clinical data demonstrating the reproducibility and reliability of its novel infertility diagnosis platform MiOXSYS™ has been published in the peer-reviewed, scientific journal Reproductive BioMedicine Online. The data establish a clear protocol for reproducible sampling and a clinical cut-off value for distinguishing infertile men from healthy ones. In the article titled, "Diagnostic application of oxidation-reduction potential assay for measurement of oxidative stress: clinical utility in male factor infertility," researchers used MiOXSYS to compare the semen of control volunteers versus infertile patients for signs of oxidative stress (OS) by measuring sORP (static oxidation-reduction potential), which directly measures the balance of harmful reactive oxygen species versus antioxidants. They found a significant difference in sORP between control volunteers (1.59 ± 0.29 mV/10 6 sperm/ml) versus infertile volunteers (6.22 ± 1.10 mV/10 6 sperm/ml) (P = 0.004). This difference was even more significant in the subset of infertile individuals presenting with varicocele (P = 0.0003). The variability of the MiOXSYS readings was also analyzed to assess reproducibility across multiple users. The coefficients of variation for three independent users of the MiOXSYS platform were 7.98%, 5.72%, and 11.96%, with an average difference between any two replicates of < 0.1 mV/10 6 sperm/ml. Variability analysis between users yielded a coefficient of variation of 3.61%, with no statistically significant difference between the three users' readings. This reproducibility confirms the suitability of MiOXSYS for broad use in the clinical setting.