Miraculins Inc announces the launch of its PSP94 Immunoassay for urine specimens, a research use only (RUO) tool utilizing enzyme linked immunosorbent assay (ELISA) for the detection of PSP94 in urine.

The company also announces the signing of a one-year non-exclusive distribution agreement with GenWay Biotech for the world-wide sales and marketing of the immunoassay.

Prostate Secretory Protein (PSP94) is the lead marker from Miraculins’ prostate cancer program and has been the subject of research by Miraculins for a number of years. PSP94, also known as beta-microseminoprotein, or inhibin-like peptide, is a basic 94 amino acid protein found in high concentration in the epithelial cells of the prostate. The marker has been examined in independent literature for its potential to be a cancer biomarker and was found to be decreased in the 24 hour collection of urine from men with late stage tumors compared to men with enlarged prostate or benign prostatic hyperplasia (Teni TR, et al, Clin Chem 1989: 35; 1376-79). Miraculins has completed a number of studies which have added to the growing body of evidence that levels of PSP94 are decreased in the urine of men with prostate cancer. Further research is needed to confirm the utility of PSP94 as a biomarker in this setting.

The Miraculins PSP94 ELISA kit has been developed to allow researchers to expand on these findings in a simple rapid test. The kit includes a precoated 96 well plate of anti-PSP94, an anti-PSP94 peroxidase conjugate, a 12 ng/mL PSP94 calibrator, wash buffer, assay buffer, color developer and a stop solution. The Miraculins PSP94 ELISA kit has shown extremely high sensitivity thereby minimizing the effect of potential interfering substances. The coefficient of variation (CV) for the assay is less than 7% and the dilution linearity of urine is a nearly perfect correlation coefficient of 0.999.

"We are impressed with the potential of the PSP94 marker and the quality of the Miraculins kit," stated Matthew Landry, Vice-President of Sales and Marketing for GenWay Biotech. "GenWay is excited about making this product available to our extensive customer base."
"This product provides a robust means of determining PSP94 in urine and will allow for the further study of PSP94 in research settings," said Christopher J. Moreau, president and CEO of Miraculins Inc. "Adding the dedicated and knowledgeable sales, marketing and distribution capabilities of a partner like GenWay is an important step towards our goal of making our test widely available to the academic community throughout the world and encouraging further study of PSP94 in preclinical and non-clinical settings."

Source: Miraculins